Science.gov

Sample records for efficacy supplement approvals

  1. Efficacy of nutritional supplements used by athletes.

    PubMed

    Beltz, S D; Doering, P L

    1993-12-01

    Findings on the efficacy of nutritional supplements used by athletes are reviewed. Many athletes have turned away from anabolic steroids and toward nutritional supplements in the hope of gaining a competitive edge without threatening their health. Athletes may require slightly more protein than sedentary people do to maintain positive nitrogen balance, but it is dubious whether extra dietary protein will help someone to achieve athletic goals. Purified amino acids have become a popular if expensive form of protein supplementation; there is no scientific evidence, however, to support their use. Excessive protein supplementation can lead to dehydration, gout, liver and kidney damage, calcium loss, and gastrointestinal effects. Supplementation with vitamins and minerals in excess of recommended daily allowances appears to have no effect on muscle mass or athletic performance. Other substances touted as having ergogenic properties are carnitine, cobamamide, growth hormone releasers, octacosanol, and ginseng; again, there is no reliable scientific evidence to support claims that products containing these compounds have ergogenic potential, and heavy supplementation may lead to adverse effects. Nutritional supplements are promoted through unsubstantiated claims by magazine advertisements, health food stores, coaches, and other sources. The FDA considers nutritional supplements to be foodstuffs, not drugs, and therefore has not required that they be proved safe and effective. Dosage guidelines are inadequate, and quality control is poor. The FDA has begun to revise regulations governing labeling and health claims for these products. There is little if any evidence that nutritional supplements have ergogenic effects in athletes consuming a balanced diet, and some products have the potential for harm.

  2. Accelerated approval of drugs: ethics versus efficacy.

    PubMed

    Chary, Krishnan V; Pandian, Kumaresh

    2017-06-27

    To analyse the post-marketing status of molecules approved through the expedited review process in the last quintile. This observational study was carried out between January 2016 and June 2016. The details of the time taken to approve drugs were collected from the official website of United States Food and Drug Administration (FDA). The average time taken to review drugs and take a decision following the review were ascertained from the FDA's annual release of novel drugs from 2011 to 2015. Information on adverse drug reactions noted after approval was gathered from the FDA Drug Safety Communication and FDA Adverse Event Reporting System (FAERS). In the last five years, 166 products were approved by expedited review. Of these, 45 (27.1%) did not meet the stringent criteria framed for expedited review. Reports of serious adverse event alerts were submitted for 79 (47.5%) of the 166 molecules. Fourteen (8.4%) drugs were associated with inducing severe autoimmune disorders. It can be observed that a lower average time of review is positively correlated with a greater number of adverse events (p<0.05). Thirty-seven (45.7%) of the molecules failed to be of any benefit in the treatment scenario. Drug approval by accelerated review should be stringent. Beneficence and non-maleficence are applicable to the global population, and should apply equally to subjects involved in trials. Approving drugs on the basis of trivial evidence is non-scientific and absolutely unethical, since it can lead to clinical failure and produce serious adverse events.

  3. 21 CFR 314.71 - Procedures for submission of a supplement to an approved application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Procedures for submission of a supplement to an approved application. 314.71 Section 314.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A...

  4. 29 CFR 1953.6 - Review and approval of plan supplements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... previously approved State standards which do not change the meaning or requirements of the standard. OSHA...) OSHA shall review a supplement to determine whether it is at least as effective as the Federal program.... If the review reveals any defect in the supplement, or if more information is needed, OSHA shall...

  5. 29 CFR 1953.6 - Review and approval of plan supplements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... previously approved State standards which do not change the meaning or requirements of the standard. OSHA...) OSHA shall review a supplement to determine whether it is at least as effective as the Federal program.... If the review reveals any defect in the supplement, or if more information is needed, OSHA shall...

  6. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... effectiveness data in the parent application. Category I supplements include the following: (i) A corporate... II. Supplements that may require a reevaluation of certain safety or effectiveness data in the parent... prescription drug advertising. (x) A change in the drug withdrawal period prior to slaughter or in the...

  7. Efficacy of Vitamin D3 Supplementation on Osseointegration of Implants.

    PubMed

    Javed, Fawad; Malmstrom, Hans; Kellesarian, Sergio Varela; Al-Kheraif, Abdulaziz A; Vohra, Fahim; Romanos, Georgios E

    2016-04-01

    The aim was to systematically review the efficacy of vitamin D3 (VD3) supplementation on the osseointegration of implants. The addressed focused question was "does VD3 supplementation affect osseointegration around implants?" Indexed databases were searched from 1969 up to and including March 2015 using various key words including: "Bone to implant contact"; "implant"; "vitamin D"; and "osseointegration." Letters to the editor, case reports/case series, reviews, and articles published in languages other than English were excluded. The pattern of the present systematic review was customized to primarily summarize the pertinent data. Six experimental studies (4 in rodents and 2 in rabbits) were included. Number of titanium implants placed ranged between 28 and 100 implants. Results from 5 studies showed that VD3 supplementation enhanced new bone formation and/or bone to implant contact (BIC) around implants. One study showed no significant difference in BIC and new bone formation around VD3 coated and noncoated implants. One study reported that insulin therapy with adjunct VD3 supplementation enhances new bone formation around implants in diabetic rats than when insulin replacement therapy is used alone. Efficacy of VD3 supplementation on osseointegration of implants remains controversial and requires further investigations.

  8. Efficacy and Safety of Saffron Supplementation: Current Clinical Findings.

    PubMed

    Broadhead, G K; Chang, A; Grigg, J; McCluskey, P

    2016-12-09

    Saffron (Crocus savitus) is a Middle-Eastern herb with strong antioxidant properties. Its major constituents, safranal, crocin, and crocetin, are also antioxidants and bear structural similarities to other well-known natural antixodant substances, such as zeaxanthin. Given the role of oxidative stress in many diseases, considerable interest has been shown into the potential role of saffron supplementation as a treatment for a range of diseases. In vitro and animal studies have provided evidence that saffron and its constituents may be potent therapies for a range of pathologies, including Alzheimer's disease, age-related macular degeneration (AMD) and cardiac ischemia. Whether these findings translate into clinical efficacy, however, has as of yet been incompletely assessed. This makes assessing the role of saffron supplementation in these diseases difficult. Here, we review the current human clinical evidence supporting saffron supplementation as a treatment for a range of pathologies and the underlying science supporting its use.

  9. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... application. 514.8 Section 514.8 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUG APPLICATIONS General Provisions § 514.8 Supplements and other changes to an approved application. (a) Definitions. (1)...

  10. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... prescription drug, any mailing or promotional piece used after the drug is placed on the market is labeling... permitted labeling. (3) Prescription drug labeling not requiring an approved supplemental application is... labeling, promotional labeling, or prescription drug advertising of additional warning,...

  11. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... prescription drug, any mailing or promotional piece used after the drug is placed on the market is labeling... permitted labeling. (3) Prescription drug labeling not requiring an approved supplemental application is... labeling, promotional labeling, or prescription drug advertising of additional warning,...

  12. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... prescription drug, any mailing or promotional piece used after the drug is placed on the market is labeling... permitted labeling. (3) Prescription drug labeling not requiring an approved supplemental application is... labeling, promotional labeling, or prescription drug advertising of additional warning,...

  13. Efficacy of a food supplement in patients with hashimoto thyroiditis.

    PubMed

    Nordio, M; Basciani, S

    2015-01-01

    Thyroid inflammation has been commonly seen in recent decades, due to a series of factors and is considered as the most frequent thyroid illness. It is characterized by some distinctive traits, which include morphological and hormonal modifications, often in association with an elevated anti-thyroid autoantibody title. The aim of the therapy is to improve symptoms as fast as possible, treating inflammation and subsequent hypothyroidism, when present. Therefore, we evaluated the efficacy of a Food Supplement (FS) containing enzymes which is commonly used in various inflammatory processes and is able to modulate immune reactions during inflammation in a very rapid and efficacious way. An open, controlled study was then designed and 45 patients with Hashimoto thyroiditis were enrolled and divided into 3 groups (FS alone; thyroid hormones alone; FS plus thyroid hormones). Blood, morphological and subjective parameters were considered. The results obtained indicate that the FS used in our study is efficacious and safe when used alone and/or in combination with thyroid hormones in the treatment of autoimmune thyroiditis, as documented by the improvement of the majority of the parameters considered. The efficacy was considered faster than thyroid hormones alone as far as subjective symptomatology is considered. In conclusion, the use of the food supplement evaluated herein during inflammation may be considered an additional tool in clinicians’ hands, when facing patients with autoimmune thyroiditis, especially in presence of subjective symptomatology, in order to rapidly alleviate it.

  14. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... supplement that quality control personnel approve for reprocessing? 111.525 Section 111.525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned...

  15. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... supplement that quality control personnel approve for reprocessing? 111.525 Section 111.525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned...

  16. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... supplement that quality control personnel approve for reprocessing? 111.525 Section 111.525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned...

  17. Efficacy and safety of ingredients found in preworkout supplements.

    PubMed

    Eudy, Anne E; Gordon, Lindsay L; Hockaday, Brandon C; Lee, Daniel A; Lee, Vivianne; Luu, Daniel; Martinez, Carlos A; Ambrose, Peter J

    2013-04-01

    Published evidence on common ingredients of "energy drinks" and other dietary supplements widely used by consumers in hopes of enhancing athletic performance is reviewed. Preworkout products- unregulated dietary supplements- typically contain "proprietary blends" of multiple ingredients, including caffeine, dimethylamylamine, creatine, arginine, β-alanine, taurine, and phosphates. While some dietary supplement labels instruct consumers to seek the advice of a health care professional before using the products, the labels usually do not disclose all ingredients or their precise amounts, and evidence to support the purported performance-enhancing benefits is generally lacking. There is limited evidence to support the use of some preworkout supplement ingredients. For example, in one small placebo-controlled study (n = 12), the use of the energy drink Red Bull (containing caffeine and taurine) 40 minutes before a simulated cycling time trial appeared to provide a meaningful ergogenic benefit; in another small study (n = 12), the use of a similar caffeine-containing product (Redline) by strength-trained athletes was found to improve reaction time, energy, and mental focus relative to placebo use. However, published evidence on the use of the other ingredients listed above is scant, inconclusive, or conflicting. Adverse effects reported in association with preworkout supplements include gastrointestinal symptoms, cardiac arrhythmia, blood pressure increases, and potential effects on lipids and blood glucose. Although evidence exists to support the performance-enhancement efficacy of some preworkout ingredients as standalone agents, published data on combination products are scant, inconclusive, or conflicting. The safety of these products may be compromised if users consume larger-than-recommended amounts or use more than one product.

  18. 30 CFR 250.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... discharged; (6) Request a new H2S area classification, or increase the concentration of H2S to a... supplement your approved EP, DPP, or DOCD when you propose to conduct activities on your lease(s) or...

  19. Efficacy considerations for U.S. Food and Drug Administration approval of diagnostic radiopharmaceuticals.

    PubMed

    Gorovets, Alexander; Marzella, Louis; Rieves, Dwaine; Yang, Lucie

    2013-08-01

    The safety and efficacy expectations for U.S. Food and Drug Administration (FDA) approval of diagnostic radiopharmaceuticals (DRs) are described in laws that broadly apply to all prescription drugs and biologic products. These laws also outline efficacy expectations that are unique for DRs. The FDA regulations and guidance documents elaborate on DR efficacy expectations for clinical uses of the drugs, such as the delineation of anatomy, the characterization of a physiologic process, or the diagnosis of disease. As described in the FDA regulations, the approval of a DR necessitates that the imaging drug has the ability to provide clinically useful information. Here we cite approved DRs to illustrate how the imaging performance of the drugs was characterized in clinical studies and the clinical usefulness of the imaging information described in drug labels.

  20. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

    PubMed

    Zheng, Sarah Y; Dhruva, Sanket S; Redberg, Rita F

    2017-08-15

    High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data). Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015. Panel-track supplement approval. Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements. Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were

  1. Efficacy of twice weekly iron supplementation in anemic adolescent girls.

    PubMed

    Shobha, S; Sharada, D

    2003-12-01

    Two hundred and forty four girls with different hemoglobin levels were selected, of which forty-one were non-anemic. The rest were graded as mildly, moderately or severely anemic and supplemented with 60 mg of iron daily or twice weekly for twelve weeks. There was no significant difference in the increase in hemoglobin levels between daily and twice weekly-supplemented subjects at the end of the study. Unpleasant side effects of supplementation were experienced by 57.8% of the daily supplemented subjects as against 5.9% of twice weekly-supplemented ones. Twice weekly supplementation could be recommended for overcoming anemia in adolescent girls.

  2. Efficacy and Safety of Leucine Supplementation in the Elderly.

    PubMed

    Borack, Michael S; Volpi, Elena

    2016-12-01

    Leucine supplementation has grown in popularity due to the discovery of its anabolic effects on cell signaling and protein synthesis in muscle. The current recommendation is a minimum intake of 55 mg ⋅ kg(-1)(.) d(-1) Leucine acutely stimulates skeletal muscle anabolism and can overcome the anabolic resistance of aging. The value of chronic leucine ingestion for muscle growth is still unclear. Most of the research into leucine consumption has focused on efficacy. To our knowledge, very few studies have sought to determine the maximum safe level of intake. Limited evidence suggests that intakes of ≤1250 mg ⋅ kg(-1)(.) d(-1) do not appear to have any health consequences other than short-term elevated plasma ammonia concentrations. Similarly, no adverse events have been reported for the leucine metabolite β-hydroxy-β-methylbutyrate (HMB), although no studies have tested HMB toxicity in humans. Therefore, future research is needed to evaluate leucine and HMB toxicity in the elderly and in specific health conditions. © 2016 American Society for Nutrition.

  3. Examining the Mediating Effect of Self-Efficacy on Approval of Aggression and Proactive Aggression

    ERIC Educational Resources Information Center

    Hadley, Jade; Mowbray, Tony; Jacobs, Nicky

    2017-01-01

    Proactive aggression (PA) is goal-directed, hostile social behavior that has been linked to detrimental outcomes. It has been theorized that adolescents who believe aggression is a normal and acceptable social response (approval of aggression) are more likely to show PA. Confidence in one's ability to behave aggressively (self-efficacy about…

  4. Examining the Mediating Effect of Self-Efficacy on Approval of Aggression and Proactive Aggression

    ERIC Educational Resources Information Center

    Hadley, Jade; Mowbray, Tony; Jacobs, Nicky

    2017-01-01

    Proactive aggression (PA) is goal-directed, hostile social behavior that has been linked to detrimental outcomes. It has been theorized that adolescents who believe aggression is a normal and acceptable social response (approval of aggression) are more likely to show PA. Confidence in one's ability to behave aggressively (self-efficacy about…

  5. Efficacy comparison of medications approved for chronic weight management.

    PubMed

    Kumar, Rekha B; Aronne, Louis J

    2015-04-01

    For the first time, patients who are obese are able to benefit from 5 different FDA approved pharmacologic agents for chronic weight management. Although weight loss from all of these medications was limited to 5% to 10% of total body weight loss in the Phase III clinical trials, patients are capable of losing more weight when a cumulative approach of diet, exercise, and multiple medications are used. A pilot study of adding phentermine to lorcaserin yielded double the weight loss than lorcaserin alone. A higher percentage of total body weight is lost with use of combination phentermine/topiramate compared to orlistat, lorcaserin, and bupropion/naltrexone but there are more contraindications to its use and potential cardiovascular adverse effects due to adrenergic agonism. Lorcaserin and bupropion/naltrexone yielded similar weight loss but carry different adverse effect profiles and interactions with other psychiatric medications may preclude use of one over the other. When choosing a medication for obesity, several factors need to be considered, such as comorbidities, medication interactions, and risk of potential adverse effects.

  6. 77 FR 65198 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-25

    ... HUMAN SERVICES Food and Drug Administration Generic Drug User Fee--Abbreviated New Drug Application, Prior Approval Supplement, and Drug Master File Fee Rates for Fiscal Year 2013 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the rate for...

  7. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? 111.525 Section 111.525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

  8. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? 111.525 Section 111.525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

  9. 78 FR 46977 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... HUMAN SERVICES Food and Drug Administration Generic Drug User Fee--Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2014 AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  10. Efficacy of Ginseng Supplements on Fatigue and Physical Performance: a Meta-analysis

    PubMed Central

    2016-01-01

    We conducted a meta-analysis to investigate the efficacy of ginseng supplements on fatigue reduction and physical performance enhancement as reported by randomized controlled trials (RCTs). RCTs that investigated the efficacy of ginseng supplements on fatigue reduction and physical performance enhancement compared with placebos were included. The main outcome measures were fatigue reduction and physical performance enhancement. Out of 155 articles meeting initial criteria, 12 RCTs involving 630 participants (311 participants in the intervention group and 319 participants in the placebo group) were included in the final analysis. In the fixed-effect meta-analysis of four RCTs, there was a statistically significant efficacy of ginseng supplements on fatigue reduction (standardized mean difference, SMD = 0.34; 95% confidence interval [CI] = 0.16 to 0.52). However, ginseng supplements were not associated with physical performance enhancement in the fixed-effect meta-analysis of eight RCTs (SMD = −0.01; 95% CI = −0.29 to 0.27). We found that there was insufficient clinical evidence to support the use of ginseng supplements on reducing fatigue and enhancing physical performance because only few RCTs with a small sample size have been published so far. Further lager RCTs are required to confirm the efficacy of ginseng supplements on fatigue reduction. PMID:27822924

  11. Efficacy of Ginseng Supplements on Fatigue and Physical Performance: a Meta-analysis.

    PubMed

    Bach, Hoang Viet; Kim, Jeongseon; Myung, Seung Kwon; Cho, Young Ae

    2016-12-01

    We conducted a meta-analysis to investigate the efficacy of ginseng supplements on fatigue reduction and physical performance enhancement as reported by randomized controlled trials (RCTs). RCTs that investigated the efficacy of ginseng supplements on fatigue reduction and physical performance enhancement compared with placebos were included. The main outcome measures were fatigue reduction and physical performance enhancement. Out of 155 articles meeting initial criteria, 12 RCTs involving 630 participants (311 participants in the intervention group and 319 participants in the placebo group) were included in the final analysis. In the fixed-effect meta-analysis of four RCTs, there was a statistically significant efficacy of ginseng supplements on fatigue reduction (standardized mean difference, SMD = 0.34; 95% confidence interval [CI] = 0.16 to 0.52). However, ginseng supplements were not associated with physical performance enhancement in the fixed-effect meta-analysis of eight RCTs (SMD = -0.01; 95% CI = -0.29 to 0.27). We found that there was insufficient clinical evidence to support the use of ginseng supplements on reducing fatigue and enhancing physical performance because only few RCTs with a small sample size have been published so far. Further lager RCTs are required to confirm the efficacy of ginseng supplements on fatigue reduction.

  12. Daily iron supplementation is more efficacious than twice weekly iron supplementation for the treatment of childhood anemia in western Kenya.

    PubMed

    Desai, Meghna R; Dhar, Ritesh; Rosen, Daniel H; Kariuki, Simon K; Shi, Ya Ping; Kager, Piet A; Ter Kuile, Feiko O

    2004-05-01

    A recent meta-analysis of 14 clinical trials indicated that daily compared with intermittent iron supplementation resulted in significantly greater hematological improvement in pregnant women. No such definitive beneficial effect was demonstrated in preschool children. We compared the efficacy of daily and twice weekly iron supplementation for 6 wk under supervised and unsupervised conditions in the treatment of mild and moderate anemia [hemoglobin (Hb) 50-109 g/L] in children aged 2-59 mo living in a malaria-endemic area of western Kenya. The study was a cluster-randomized trial using a factorial design; participants were aware of the treatment assigned. All children (n = 1049) were administered a single dose of sulfadoxine-pyrimethamine at enrollment followed by 6 wk of daily supervised iron supplementation [3-6 mg/(kg.d)], twice weekly supervised iron supplementation [6-12 mg/(kg.wk)], daily unsupervised iron supplementation, or twice weekly unsupervised iron supplementation. In the supervised groups, Hb concentrations at 6 and 12 wk (6 wk postsupplementation) were significantly higher in children given iron daily rather than twice weekly [mean (95% CI) difference at 6-wk: 4.2 g/L (2.1, 6.4); 12-wk: 4.4 g/L (1.8, 7.0)]. Among the unsupervised groups, Hb concentrations were not different at 6 wk [mean (95% CI) difference: 0.86 g/L (-1.4, 3.1)], but significantly higher at 12 wk for those assigned daily iron [mean (95% CI) difference: 3.4 g/L (0.79, 6.0), P = 0.02]. In this malarious area and after initial antimalarial treatment, 6 wk of daily iron supplementation results in better hematological responses than twice weekly iron supplementation in the treatment of anemia in preschool children, regardless of whether adherence can be ensured.

  13. Iron supplements: scientific issues concerning efficacy and implications for research and programs.

    PubMed

    Allen, Lindsay H

    2002-04-01

    Iron supplementation remains an important strategy for the prevention and treatment of iron deficiency anemia and can produce substantial improvements in the functional performance of iron deficient individuals and populations. Many potential benefits of iron supplementation require further exploration, including its effect on vitamin A and iodine metabolism. There is strong evidence that vitamin A and riboflavin deficiencies affect iron utilization from supplements and are important on a global scale, but little evidence that folate and vitamin B-12 deficiencies play a major causal role in the global burden of anemia. The efficacy of multiple micronutrient supplements for the prevention and treatment of anemia must be further evaluated. Because weekly supplementation with iron is effective at improving iron status, this option should be thoroughly explored and evaluated in the context of programs for the prevention and the treatment of iron deficiency and anemia. More conformation is warranted concerning the number of tablets that must be consumed in different situations, and the efficacy of supplying other micronutrients weekly with iron. Weekly supplementation programs may improve the logistical and economic constraints that currently limit the provision of supplements to the many target population groups for whom they are recommended, but usually fail to reach. Further work is required to clarify the purpose, delivery and outcomes of iron supplementation programs.

  14. Safety, Efficacy, and Legal Issues Related to Dietary Supplements

    ERIC Educational Resources Information Center

    Powers, Michael

    2004-01-01

    This article focuses on the effects of dietary supplements on collegiate and adult populations. Anabolic steroids, amphetamines, and other drugs have been used for decades to improve athletic performance. However, the legal issues and dangers associated with these drugs have resulted in reluctance by many athletes to use them. Because dietary…

  15. Safety, Efficacy, and Legal Issues Related to Dietary Supplements

    ERIC Educational Resources Information Center

    Powers, Michael

    2004-01-01

    This article focuses on the effects of dietary supplements on collegiate and adult populations. Anabolic steroids, amphetamines, and other drugs have been used for decades to improve athletic performance. However, the legal issues and dangers associated with these drugs have resulted in reluctance by many athletes to use them. Because dietary…

  16. [DIETARY SUPPLEMENT REKECEN IMPROVES SAFETY AND EFFICACY OF CHRONIC PROSTATITIS ANTIBACTERIAL THERAPY].

    PubMed

    Kuznetsov, V F; Davidov, M I; Sokolov, A P; Kuznetsov, S V

    2015-01-01

    This randomized comparative study was carried out to estimate efficacy and safety of the natural complex of fermented food fibers and short chain fatty acids (dietary supplement rekicen-RD®) in antibacterial therapy of 64 patients with chronic infectious prostatitis. 32 patients of the treatment group received 8 week standard antibacterial therapy for chronic prostatitis in combination with dietary supplement rekicen-RD® and 32 patients of the control group were treated only with antibacterial therapy. Short-term and long-term results were estimated after 8 weeks and 6 months follow-up, respectively. It was found, that addition of dietary supplement rekicen- RD® to antibacterial therapy resulted in statistically significant improvement of the treatment efficacy. Compared to patients of the control group, patients of the treatment group had more pronounced positive changes of all indicators of treatment efficacy (NIH-CPSI total score, quality of life, echo-structure of prostate, the number of leukocytes in prostatic secretions). Long-term (after 6 months) clinical efficacy of the combination of antibacterial therapy with dietary supplement rekicen-RD® was 96,9%, bacteriological efficacy after 8 weeks - 87,5%, after 6 months - 81%. Notably, there was 4,5-fold reduction in the rate of antibiotics adverse side effects in the treatment group patients without a single gastro-intestinal side effect.

  17. Efficacy trials of a micronutrient dietary supplement in schoolchildren and pregnant women in Tanzania.

    PubMed

    Latham, Michael C; Ash, Deborah M; Makola, Diklar; Tatala, Simon R; Ndossi, Godwin D; Mehansho, Haile

    2003-12-01

    Traditionally, the main strategies used to control micronutrient deficiencies have been food diversification, consumption of medicinal supplements, and food fortification. In Tanzania, we conducted efficacy trials using a dietary supplement as a fourth approach. These were randomized, double-blind, placebo-controlled efficacy trials conducted separately first in children and later in pregnant women. The dietary supplement was a powder used to prepare an orange-flavored beverage. In the school trial, children consumed 25 g per school day attended. In the pregnancy trial, women consumed the contents of two 25-g sachets per day with meals. This dietary supplement, unlike most medicinal supplements, provided 11 micronutrients, including iron and vitamin A, in physiologic amounts. In both trials we compared changes in subjects consuming either the fortified or the nonfortified supplement. Measures of iron and vitamin A status were similar in the groups at the baseline examination, but significantly different at follow-up, always in favor of the fortified groups. Children receiving the fortified supplement had significantly improved anthropometric measures when compared with controls. At four weeks postpartum, the breast milk of a supplemented group of women had significantly higher mean retinol content than did the milk of mothers consuming the nonfortified supplement. The advantages of using a fortified dietary supplement, compared with other approaches, include its ability to control several micronutrient deficiencies simultaneously; the use of physiologic amounts of nutrients, rather than megadoses that require medical supervision; and the likelihood of better compliance than with the use of pills because subjects liked the beverage used in these trials.

  18. Efficacy and safety concerns are important reasons why the FDA requires multiple reviews before approval of new drugs.

    PubMed

    Ross, Joseph S; Dzara, Kristina; Downing, Nicholas S

    2015-04-01

    The regulatory approval of new drugs by the Food and Drug Administration (FDA) is a long and complex process and often requires multiple cycles of review, potentially delaying patients' access to new and effective therapeutics. We used qualitative methods to characterize the safety and efficacy reasons why applications for novel therapeutics approved by the FDA between 2001 and 2011 required multiple review cycles prior to approval. Among ninety-six applications approved between 2001 and 2011 that required multiple review cycles, safety concerns contributed to seventy-four (77.1 percent) and efficacy concerns to forty-three (44.8 percent). Our study suggests that multiple review cycles appear to play an important role in allowing the FDA to protect public health and in ensuring adequate understanding of clinical benefits and risks prior to approval.

  19. Multi-ingredient, caffeine-containing dietary supplements: history, safety, and efficacy.

    PubMed

    Gurley, Bill J; Steelman, Susan C; Thomas, Sheila L

    2015-02-01

    Our objective was to review the history, safety, and efficacy of caffeine-containing dietary supplements in the United States and Canada. PubMed and Web of Science databases (1980-2014) were searched for articles related to the pharmacology, toxicology, and efficacy of caffeine-containing dietary supplements with an emphasis on Ephedra-containing supplements, Ephedra-free supplements, and energy drinks or shots. Among the first and most successful dietary supplements to be marketed in the United States were those containing Ephedra—combinations of ephedrine alkaloids, caffeine, and other phytochemicals. A decade after their inception, serious tolerability concerns prompted removal of Ephedra supplements from the US and Canadian markets. Ephedra-free products, however, quickly filled this void. Ephedra-free supplements typically contain multiple caffeine sources in conjunction with other botanical extracts whose purposes can often be puzzling and their pharmacologic properties difficult to predict. Ingestion of these products in the form of tablets, capsules, or other solid dosage forms as weight loss aids, exercise performance enhancers, or energy boosters have once again brought their tolerability and efficacy into question. In addition to Ephedra-free solid dosage forms, caffeine-containing energy drinks have gained a foothold in the world market along with concerns about their tolerability. This review addresses some of the pharmacologic and pharmaceutical issues that distinguish caffeine-containing dietary supplement formulations from traditional caffeine-containing beverages. Such distinctions may account for the increasing tolerability concerns affiliated with these products. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

  20. A Review of the Efficacy, Safety, and Clinical Implications of Naturally Derived Dietary Supplements for Dyslipidemia.

    PubMed

    Thaipitakwong, Thanchanit; Aramwit, Pornanong

    2017-02-01

    Dyslipidemia is recognized as a major cause of cardiovascular disease. A number of evidence-based guidelines recommend conventional synthetic drugs as standard therapy for dyslipidemia in clinical practice. However, antihyperlipidemic drugs have some serious side effects. Naturally derived dietary supplements are becoming attractive as an alternative strategy because of their high efficacy and safety, as supported by numerous data. Moreover, they could be considered an initial treatment for dyslipidemia. The aims of this literature review were to demonstrate the efficacy, safety, and clinical implications of dietary supplements for treating dyslipidemia. We reviewed the literature, including data from in vitro, in vivo, and human studies, and clinical guideline recommendations. We classified dietary supplements by their proposed mechanisms of action on lipid metabolism and also collected daily dosage recommendations, interactions with concurrent drugs and/or foods, dosage forms, and examples of commercially available products. Various types of naturally derived dietary supplements exhibit lipid-improving properties. Efficacy and safety are acceptable; however, their use in clinical practice will require further well-designed investigations and the support of scientific data.

  1. 78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

    ... holders of an approved drug or biological product to change the product labeling to reflect certain types... biological product to change the product labeling to reflect certain types of newly acquired information in... Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of...

  2. Efficacy of iron fortification compared to iron supplementation among Vietnamese schoolchildren.

    PubMed

    Thi Le, Huong; Brouwer, Inge D; Burema, Jan; Nguyen, Khan Cong; Kok, Frans J

    2006-12-05

    The effect of iron fortification is generally assumed to be less than iron supplementation; however, the magnitude of difference in effects is not known. The present study aims to compare the efficacy of these two strategies on anaemia and iron status. After screening on low Hb, 425 anaemic children in six primary schools in Tam Nong district of Phu Tho province were included in a randomized, placebo-controlled trial comparing two groups receiving iron fortified instant noodles or iron supplementation for 6 months and a control group, with children in all groups having been dewormed. Blood samples were collected before and after intervention for haemoglobin, serum ferritin (SF), serum transferrin receptor (TfR), C-reactive protein (CRP), and haemoglobinopathies analysis. Regression analysis was used to assess the effect of iron fortification and iron supplementation on haemoglobin concentration, SF, TfR, body iron, and anaemic status as outcome variables. The improvement of haemoglobin, SF, and body iron level in the group receiving iron fortification was 42% (2.6 g/L versus 6.2 g/L), 20% (23.5 microg/L versus 117.3 microg/L), and 31.3% (1.4 mg/kg versus 4.4 mg/kg) of that in the iron supplementation group. The prevalence of anaemia dropped to 15.1% in the control group, with an additional reduction of anaemia of 8.5% in the iron supplementation group. The additional reduction due to iron fortification was 5.4%, which amounts to well over 50% of the impact of supplementation. In conclusion, the efficacy of iron fortification based on reduction of prevalence of anaemia, and on the change in haemoglobin level, is about half of the maximum impact of supplementation in case of optimal compliance. Thus, in a population of anaemic children with mild iron deficiency, iron fortification should be the preferred strategy to combat anaemia.

  3. Efficacy of iron fortification compared to iron supplementation among Vietnamese schoolchildren

    PubMed Central

    Thi Le, Huong; Brouwer, Inge D; Burema, Jan; Nguyen, Khan Cong; Kok, Frans J

    2006-01-01

    The effect of iron fortification is generally assumed to be less than iron supplementation; however, the magnitude of difference in effects is not known. The present study aims to compare the efficacy of these two strategies on anaemia and iron status. After screening on low Hb, 425 anaemic children in six primary schools in Tam Nong district of Phu Tho province were included in a randomized, placebo-controlled trial comparing two groups receiving iron fortified instant noodles or iron supplementation for 6 months and a control group, with children in all groups having been dewormed. Blood samples were collected before and after intervention for haemoglobin, serum ferritin (SF), serum transferrin receptor (TfR), C-reactive protein (CRP), and haemoglobinopathies analysis. Regression analysis was used to assess the effect of iron fortification and iron supplementation on haemoglobin concentration, SF, TfR, body iron, and anaemic status as outcome variables. The improvement of haemoglobin, SF, and body iron level in the group receiving iron fortification was 42% (2.6 g/L versus 6.2 g/L), 20% (23.5 μg/L versus 117.3 μg/L), and 31.3% (1.4 mg/kg versus 4.4 mg/kg) of that in the iron supplementation group. The prevalence of anaemia dropped to 15.1% in the control group, with an additional reduction of anaemia of 8.5% in the iron supplementation group. The additional reduction due to iron fortification was 5.4%, which amounts to well over 50% of the impact of supplementation. In conclusion, the efficacy of iron fortification based on reduction of prevalence of anaemia, and on the change in haemoglobin level, is about half of the maximum impact of supplementation in case of optimal compliance. Thus, in a population of anaemic children with mild iron deficiency, iron fortification should be the preferred strategy to combat anaemia. PMID:17147795

  4. Hair zinc levels and the efficacy of oral zinc supplementation in patients with atopic dermatitis.

    PubMed

    Kim, Jeong Eun; Yoo, Seo Rye; Jeong, Myeong Gil; Ko, Joo Yeon; Ro, Young Suck

    2014-09-01

    Zinc deficiency in patients with atopic dermatitis (AD) and the use of zinc supplementation is still controversial. We measured hair zinc levels in 58 children with AD and 43 controls (age range 2-14 years). We also investigated the efficacy of oral zinc supplementation in AD patients with low hair zinc levels by comparing eczema assessment severity index (EASI), transepidermal water loss (TEWL), and visual analogue scales for pruritus and sleep disturbance in patients receiving zinc supplementation (Group A) and others not receiving supplementation (Group B). At baseline, the mean zinc level was significantly reduced in AD patients (113.1 μg/g vs. 130.9 μg/g, p = 0.012). After 8 weeks of supplement, hair zinc level increased significantly in Group A (p < 0.001), and EASI scores, TEWL, and visual analogue scales for pruritus improved more in Group A than in Group B (p = 0.044, 0.015 and < 0.001, respectively). Thus, oral zinc supplementation may be effective in AD patients with low hair zinc levels.

  5. Efficacy and quality of antibacterial generic products approved for human use: a systematic review.

    PubMed

    Tattevin, Pierre; Crémieux, Anne-Claude; Rabaud, Christian; Gauzit, Rémy

    2014-02-01

    Concerns have recently emerged about the efficacy and the quality of antibacterial generic products approved for use in humans. We searched Medline and Embase for original research articles on antibacterial generic products published in English or French before July 2013. We selected 37 original research articles: 15 on β-lactams, 10 on glycopeptides, and 12 on other antibacterial agents. The majority of articles (73.0%) were published during 2008-2012. Study designs included analytical chemistry (n = 9), in vitro susceptibility studies (n = 14), animal experiments (n = 6, including 5 using the neutropenic mouse thigh infection model), and clinical studies in humans (n = 15). Of the 37 studies, 14 (37.8%) suggested that some generic products may be inferior to the innovator in terms of purity (n = 2), in vitro activity (n = 3), in vivo efficacy in experimental models (n = 4), clinical efficacy (n = 2), taste (n = 2), or compliance and acceptability in children (n = 1). The majority of in vitro studies (78.6%) found no significant difference between generic products and the innovator. Most (5/6) in vivo studies suggesting a difference between generic products and the innovator were performed in an animal model that is not validated for the evaluation of the efficacy of antibacterial agents. The level of evidence was constantly low in clinical studies. Published data on antibacterial generic products are limited and heterogeneous, thus precluding any attempt to generalize the study results. This systematic review suggests that additional evidence would be needed before considering a revision of the marketing authorization process for antibacterial generic products.

  6. 78 FR 65219 - Defense Federal Acquisition Regulation Supplement: Approval of Rental Waiver Requests (DFARS Case...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-31

    ... Security Cooperation Agency from the approval process for waiver or reduction of charges for the use of... Defense Security Cooperation Agency (DSCA) has seen a significant increase in the number of requests...

  7. Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately?

    PubMed

    Habibi, Roojin; Lexchin, Joel; Mintzes, Barbara; Holbrook, Anne

    2017-06-29

    This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim, compared with those approved on the basis of a serious morbidity or mortality (clinical) outcome. Physicians in primary care practices in Montreal, Vancouver, Sacramento and Toulouse, who saw sales representatives as part of their usual practice and served a non-referral population, were contacted in blocks of 25 from a randomized list of all physicians practising in the relevant metropolitan area. We compared how frequently physicians reported that sales reps made claims of serious morbidity or mortality (clinically meaningful) benefits for drugs approved on the basis of surrogate outcomes vs. drugs approved on the basis of clinical outcomes. There were 448 promotions for 58 unique brand name cardiovascular and diabetes drugs. Claims of clinically meaningful benefit were reported in 156 (45%) of the 347 promotions for surrogate outcome drugs, constituting unwarranted efficacy claims, i.e., off-label promotion. Claims of clinical benefit were reported in 72 of the 101 promotions (71%) for drugs approved on the basis of clinical outcomes, adjusted OR = 0.3 (95% CI 0.2, 0.6), P < 0.001. Claims of efficacy made in sales visit promotions for drugs approved only on the basis of surrogate outcomes extended beyond the regulator-approved efficacy information for the product in almost half of promotions. Unapproved claims of drug efficacy constitute a form of off-label promotion and merit greater attention from regulators. © 2017 The British Pharmacological Society.

  8. Efficacy of parathyroid hormone supplementation on the osseointegration of implants: a systematic review.

    PubMed

    Javed, Fawad; Al Amri, Mohammad D; Kellesarian, Sergio Varela; Al-Kheraif, Abdulaziz A; Vohra, Fahim; Calvo-Guirado, José Luis; Malmstrom, Hans; Romanos, Georgios E

    2016-05-01

    The aim of the present systematic review was to assess the efficacy of parathyroid hormone supplementation on the osseointegration of implants. The addressed focused question was Does parathyroid hormone supplementation affect osseointegration around implants? Indexed databases were searched from 1965 up to and including April 2015 using various key words including: Bone to implant contact; implant; parathyroid hormone; and osseointegration. Letters to the Editor, case-reports/case-series, historic reviews, commentaries and articles published in languages other than English were excluded. The pattern of the present systematic review was customized to primarily summarize the pertinent data. Eighteen studies fulfilled the eligibility criteria. Evidence was limited to preclinical animal studies only (11 studies in rodents, 4 in dogs and 3 in rabbits). Number of titanium implants placed ranged between 20 and 80 implants. Results from 16 studies showed that PTH supplementation enhanced new bone formation and/or BIC around implants. One study suggests that PTH-coated implants improve BIC and BA. One study showed no significant difference in BIC and new bone formation around implants with PTH hydrogel placement. Efficacy of PTH supplementation on osseointegration of implants shows promising results in animal models, however further investigation is necessary to assess the effectiveness in humans.

  9. Efficacy of dietary chromium (III) supplementation on tissue chromium deposition in finishing pigs.

    PubMed

    Wang, Min-Qi; Li, Hui; He, Yu-Dan; Wang, Chao; Tao, Wen-Jing; Du, Yong-Jie

    2012-09-01

    The study was conducted to evaluate the efficacy of different forms of trivalent chromium (Cr) supplementation on tissue chromium deposition in finishing pigs. A total of 96 pigs with an initial average body mass 65.57±1.05 kg were blocked by body mass and randomly assigned to four treatments with three replicates. Pigs were offered one of four diets including a control diet or the control diet supplemented with 200 μg/kg chromium from either chromium chloride (CrCl(3)), chromium picolinate (CrPic) or chromium nanocomposite (CrNano) for 40 days. During the trial, all pigs were given free access to feed and water. After feeding trial, eight pigs from each treatment were slaughtered for samples collection. The results showed that supplemental CrNano increased Cr content in blood, longissimus muscle, heart, liver, kidney, jejunum, and ileum (P<0.05). Supplemental Cr from three sources increased Cr excretion from all feces (P<0.05). Urinary Cr excretion was increased by CrNano or CrPic supplementation significantly. These results suggested that chromium nanocomposite exhibited more effective on tissue Cr deposition in pigs, which indicated higher absorption compared with CrCl(3) and CrPic.

  10. Efficacy of a 28-day oral cyanocobalamin supplementation on vitamin B status in Spanish institutionalized elderly.

    PubMed

    Albers, Ulrike; Pedrero-Chamizo, Raquel; Meléndez, Agustin; Pietrzik, Klaus; Castillo, Manuel J; González-Gross, Marcela

    2012-04-01

    Cobalamin deficiency is a common problem in the elderly. There is no consensus about adequate doses for supplementation. We performed an intervention study in order to establish the efficacy of a supplement providing 500 µg cyanocobalamin for four weeks in sixty-four institutionalized elderly residents, over 60 years of age, in Madrid (Spain). Before and after treatment, concentrations of serum cobalamin, serum holotranscobalamin, serum total homocysteine, and serum and red blood cell folate were analyzed. Clusters were built according to the initial cobalamin status and differences in the effect of supplementation were checked using a general linear model for repeated measures. Cobalamin and holotranscobalamin increased highly significantly from 308 to 558 pmol/L and from 54 to 96 pmol/L (p < 0.001) in the whole study group as well as in each subgroup (clustered by initial cobalamin levels, all p < 0.01), with the highest relative change in the subgroup with the lowest initial cobalamin values. Total homocysteine decreased from 15 to 13 µmol/l, p < 0.001). Only the change of cobalamin (F = 4.61, p < 0.01), but not of holotranscobalamin nor total homocysteine, depended on the initial serum cobalamin status. A supplementation with an oral supplement solution of 500 µg cyanocobalamin daily for only four weeks, a shorter period than that found in former studies, may be considered suitable in institutionalized elderly.

  11. A Study on the Self-Efficacy and Competence of Approved Clinical Instructors on Athletic Training Educational Competencies

    ERIC Educational Resources Information Center

    Ludwig, Christopher M.

    2014-01-01

    The purpose of this research was to survey allied healthcare and medical practitioners who were approved clinical instructors (ACIs) of an accredited Athletic Training Education Program to gain insight into their self-efficacy and competence on the acute care of pulmonary injuries and illnesses category in the 5th edition of the Athletic Training…

  12. Efficacious Action and Social Approval as Interacting Dimensions of Self-Esteem: A Tentative Formulation Through Construct Validation

    ERIC Educational Resources Information Center

    Franks, David D.; Marolla, Joseph

    1976-01-01

    A theoretical and operational rationale is presented for the development of multidimensional measures of self-esteem. Self-esteem is conceptualized as a function of two processes reflected appraisals of significant others in one's social environment in the form of social approval, and the individual's feelings of efficacy and competence derived…

  13. Efficacious Action and Social Approval as Interacting Dimensions of Self-Esteem: A Tentative Formulation Through Construct Validation

    ERIC Educational Resources Information Center

    Franks, David D.; Marolla, Joseph

    1976-01-01

    A theoretical and operational rationale is presented for the development of multidimensional measures of self-esteem. Self-esteem is conceptualized as a function of two processes reflected appraisals of significant others in one's social environment in the form of social approval, and the individual's feelings of efficacy and competence derived…

  14. A Study on the Self-Efficacy and Competence of Approved Clinical Instructors on Athletic Training Educational Competencies

    ERIC Educational Resources Information Center

    Ludwig, Christopher M.

    2014-01-01

    The purpose of this research was to survey allied healthcare and medical practitioners who were approved clinical instructors (ACIs) of an accredited Athletic Training Education Program to gain insight into their self-efficacy and competence on the acute care of pulmonary injuries and illnesses category in the 5th edition of the Athletic Training…

  15. Association between general self-efficacy level and use of dietary supplements in the group of American football players.

    PubMed

    Gacek, Maria

    2016-01-01

    Increased nutritional demands of athletes should be covered with a variable well-balanced diet, supported by dietary supplements stimulating synthesis of energy, development of muscle mass and strength, and improving physical capacity. The aim of this study was to analyze an association between the level of general self-efficacy and dietary supplement use among Polish athletes practicing American football on a competitive basis. The study included the group of 100 athletes (20-30 years of age, mean 24.27±2.76 years) who practiced American football on a competitive basis. The popularity of various dietary supplements was determined with an original survey, and the level of general self-efficacy with General Self-Efficacy Scale (GSES) by Schwarzer et al. Statistical analysis, conducted with Statistica 10.0 PL software, included intergroup comparisons with the Chi-square test. Isotonic drinks (74%), vitamin (65%) and mineral supplements (50%) and protein concentrates (53%) turned out to be the most popular ergogenic supplements among the American footballers. The group of less popular supplements included caffeine and/or guarana (44%), joint supporting supplements (40%), BCAA amino acids (39%), creatine (36%), carbohydrate concentrates (30%) and omega-3 fatty acids (30%). Analysis of a relationship between the popularity of ergogenic supplements and general self-efficacy showed that the athletes presenting with lower levels of this trait used multivitamin supplements significantly more often than did the persons characterized by lower self-efficacy levels (p<0.05). The popularity of some dietary supplements varied depending on the general self-efficacy level of the athletes; the popularity of vitamins was significantly higher among the sportsmen who presented with lower levels of this trait.

  16. 77 FR 14480 - Defense Federal Acquisition Regulation Supplement: Commercial Determination Approval (DFARS Case...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-12

    ... a type'' or ``offered for sale'' language contained in the definition of commercial item. The rule also clarifies approval requirements for determinations for acquisitions of services exceeding $1 million using part 12 procedures but which do not meet the definition of commercial item. DATES: March...

  17. 29 CFR 1953.6 - Review and approval of plan supplements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... shall deem the change identical. This includes “plain language” rewrites of new Federal standards or... will inform the State of this determination. No further review or Federal Register publication is... publish a Federal Register notice announcing the approval. OSHA reserves the right to reconsider its...

  18. 78 FR 11754 - Approval and Promulgation of Implementation Plans; Tennessee: Knox County Supplement Motor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... December 18, 2012, (77 FR 74820), EPA proposed to approve through parallel processing Tennessee's October... action with a parallel proposal because the Agency views this as a noncontroversial submittal and... circuit by April 22, 2013. Filing a petition for reconsideration by the Administrator of this final...

  19. Peripheral neuropathy in obstetrics: efficacy and safety of α-lipoic acid supplementation.

    PubMed

    Costantino, M; Guaraldi, C; Costantino, D; De Grazia, S; Unfer, V

    2014-01-01

    Neuropathic pain during pregnancy is a common condition due to the physical changes and compression around pregnancy and childbirth that make pregnant women more prone to develop several medical conditions such as carpal tunnel syndrome, sciatica, meralgia paraesthetica and other nerve entrapment syndromes. Most of the treatments usually performed to counteract neuropathic pain are contraindicated in pregnancy so that, the management of these highly invalidating conditions remains an issue in the clinical practice. We aimed to review the efficacy and safety of alpha lipoic acid supplementation in the treatment of neuropathic pain. Lipoic acid is a co-factor essential in the regulation of mitochondrial energy. It has been demonstrated that lipoic acid supplementation is involved in several biochemical processes and actions, exerting important antioxidant and anti-inflammatory activity and significantly improving pain and paraesthesia in patients with sciatica, carpal tunnel syndrome and diabetic neuropathy. Efficacy of lipoic acid is combined with a high safety profile, making this molecule a novel candidate for the management of several diseases. Data reported so far are promising and dietary supplementation with lipoic acid seems a useful tool to contrast neuropathic pain during pregnancy.

  20. 75 FR 78779 - Order Approving Public Company Accounting Oversight Board Supplemental Budget Request To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... Supplemental Budget Request To Establish an Office of Outreach and Small Business Liaison in 2010 The Sarbanes... Commission, auditing and related attestation, quality control, ethics, and independence standards to be used... its outreach function by establishing a new Office of Outreach and Small Business Liaison (``Office of...

  1. Efficacy of Vitamin B Supplementation on Cognition in Elderly Patients With Cognitive-Related Diseases.

    PubMed

    Zhang, Dong-Mei; Ye, Jian-Xin; Mu, Jun-Shan; Cui, Xiao-Ping

    2017-01-01

    Increase in serum homocysteine is shown to be a potential risk factor for cognitive impairment. Evidence suggests that vitamin B supplementation may reduce cognitive decline by lowering the homocysteine levels. The current meta-analysis evaluated the efficacy of folic acid along with vitamin B12 and/or B6 in lowering homocysteine, thereby attenuating cognitive decline in elderly patients with Alzheimer disease or dementia. Randomized controlled trials (RCTs) comparing the efficacy of folate and B vitamin supplementation in patients with cognitive decline secondary to Alzheimer disease or dementia were identified using the keywords, "homocysteine, hyper-homocysteinemia, B vitamin, vitamin B6, B12, folic acid, cognitive, Alzheimer's disease, and dementia." The outcome measures analyzed were the Mini-Mental State Examination (MMSE) score and serum homocysteine. Of the 77 studies identified, 4 RCTs were included in the current meta-analysis. The baseline characteristics, age, and gender distribution of patients among the 2 groups (supplement vs placebo) were comparable. The results reveal that the intervention group achieved significantly greater reduction in homocysteine levels than the control (pooled difference in means = -3.625, 95% confidence interval [CI] = -5.642 to -1.608, P < .001). However, no significant difference in MMSE (pooled difference in means = 0.027, 95% CI = -0.518 to 0.573, P = 0.921) was observed between the groups. Taken together, vitamin B supplementation was effective in reducing serum homocysteine levels. However, it did not translate into cognitive improvement, indicating that the existing data on vitamin B-induced improvement in cognition by lowering homocysteine levels are conflicting.

  2. Efficacy of adding nutritional supplements in unipolar depression: A systematic review and meta-analysis.

    PubMed

    Schefft, Cora; Kilarski, Laura L; Bschor, Tom; Köhler, Stephan

    2017-10-05

    In this article, we aimed to assess the efficacy of adjunctive administration of nutritional supplements to antidepressants by means of a systematic review and meta-analysis. The supplements included were inositol, vitamin D, folic acid, vitamin B12, S-adenosyl-L-methionine (SAMe), omega-3 polyunsaturated fatty acids (n-3 PUFA) and zinc. A structured database search (MEDLINE, EBSCO, CENTRAL, Web of Science) was performed using terms for the respective substances in conjunction with terms for depression and the mode of treatment ("add-on" OR "adjunctive" OR "augmentation"). Meta-analyses, randomized controlled trials (RCTs) and non-randomized comparative studies that investigated the supplements as an add-on in the treatment of clinically diagnosed MDD were included. Agents had to be added to an existing antidepressant regime (augmentation) or started simultaneously with the antidepressant (acceleration). For n-3 PUFAs, folic acid and zinc, new meta-analyses were performed as part of this work. Our meta-analyses of 10 articles on n-3 PUFAs and four on zinc support their efficacy. For folic acid, our meta-analysis does not support efficacy. For n-3 PUFAs, sensitivity analysis showed no difference between acceleration and augmentation designs, but significant differences between individuals with or without comorbidities. For the remaining substances, only a few RCTs were available. The preliminary data on inositol was negative, while one RCT for vitamin D demonstrated positive results. For vitamin B12 one and for SAMe two RCTs and a few open trials are available reporting positive and mixed results. To summarize, for most of the substances, the available data is not yet sufficient or inconclusive. Copyright © 2017 Elsevier B.V. and ECNP. All rights reserved.

  3. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... by Month Approvals, tentative approvals, and supplements Original New Drug Approvals (NDAs and BLAs) by Month All applications ... FDA. Does not include tentative approvals. Original Abbreviated New Drug Approvals (ANDAs) by Month Generic Drug Approvals. Does ...

  4. Efficacy of probiotic supplement for gestational diabetes mellitus: a systematic review and meta-analysis.

    PubMed

    Pan, Jiajia; Pan, Qiangwei; Chen, Yumei; Zhang, Hongping; Zheng, Xiaodong

    2017-09-19

    Probiotic supplement might be beneficial for gestational diabetes mellitus. However, the results remained controversial. We conducted a systematic review and meta-analysis to explore the efficacy of probiotic supplement in gestational diabetes mellitus. PubMed, Embase, Web of science, EBSCO, and Cochrane Library databases were systematically searched. Randomized controlled trials (RCTs) assessing the effect of probiotic supplement in gestational diabetes mellitus were included. Two investigators independently searched articles, extracted data, and assessed the quality of included studies. The primary outcome were fasting serum insulin and fasting plasma glucose. Meta-analysis was performed using the fixed-effect or random-effect model. Six RCTs involving 830 patients were included in the meta-analysis. Overall, compared with control intervention in gestational diabetes mellitus, probiotic supplementation intervention was found to significantly reduce fasting serum insulin (Std. mean difference = -0.95; 95% CI = -1.73 to -0.17; p < .00001) and HOMA-IR (Std. mean difference = -1.12; 95% CI = -2.05 to -0.18; p = .02), but showed no substantial impact on fasting plasma glucose (Std. mean difference = -0.49; 95% CI = -1.05-0.08; p = .09), gestational age (Std. mean difference = 0.07; 95% CI = -0.20-0.34; p = .63), and gestational weight (Std. mean difference = -0.11; 95% CI = -0.38-0.16; p = .43). Compared with control intervention in gestational diabetes mellitus, probiotic supplementation was found to significantly reduce insulin resistance (HOMA-IR) and fasting serum insulin, but had no substantial influence on fasting plasma glucose, gestational age and gestational weight.

  5. Belimumab efficacy is 'mild' but market potential still great†: anticipating us approval of the first lupus drug since 1957.

    PubMed

    Weintraub, Ben

    2011-06-01

    Speaking for the inThought Expert Discussion Series in February, Dr George Tsokos mirrored the opinion of many lupus thought leaders: Human Genome Sciences (HGS) and GlaxoSmithKline's (GSK) belimumab (Benlysta®) was likely to be approved by the US FDA and, despite modest efficacy, will be used by a large proportion of lupus patients. Dr Tsokos praised HGS and GSK's clinical trial program for belimumab, noting that huge trials and unique trial endpoints were needed to demonstrate the drug's efficacy, allowing it to succeed where so many other lupus drugs have failed. Still, belimumab's trial design may not become standard in future lupus trials - questions about identification of appropriate lupus patients with active disease, trial endpoints, and subgrouping lupus patients remain. Although Dr Tsokos does not expect other agents currently being tested in lupus trials to be significantly more efficacious than belimumab, his research suggests that significantly better results could be obtained using agents targeting interleukin-17, spleen tyrosine kinase (SYK), and calcium/calmodulin-dependent protein kinase type IV (CaMKIV). In line with Dr Tsokos' comments and consistent with inThought's outlook for belimumab, the US FDA granted approval for belimumab in March 2011, making it the first new lupus drug to be approved in more than 50 years. inThought projects US sales of $1.1 billion for belimumab by 2017. † Adapted and reproduced from Weintraub B. Benlysta Efficacy is "Mild" but Market Potential Still Great: Anticipating U.S. Approval of the First Lupus Drug Since 1957. inThought Research, 2011 Feb 24.

  6. Efficacy and safety of protein supplements for U.S. Armed Forces personnel: consensus statement.

    PubMed

    Pasiakos, Stefan M; Austin, Krista G; Lieberman, Harris R; Askew, E Wayne

    2013-11-01

    To provide evidence-based guidance regarding the efficacy and safety of dietary protein supplement (PS) use by members of the U.S. Armed Forces, a panel of internationally recognized experts in the fields of protein metabolism and dietary supplement research was convened by the Department of Defense Center Alliance for Dietary Supplement Research and the U.S. Army Medical Research and Material Command. To develop a consensus statement, potential benefits, risks, and strategies to optimize military performance through PS use were considered in the context of specific warfighter populations and occupational demands. To maintain muscle mass, strength, and performance during periods of substantial metabolic demand and concomitant negative energy balance the panel recommended that warfighters consume 1.5-2.0 g · kg(-1) · d(-1) of protein. However, if metabolic demand is low, such as in garrison, protein intake should equal the current Military Dietary Reference Intake (0.8-1.5 g · kg(-1) · d(-1)). Although PS use generally appears to be safe for healthy adults, warfighters should be educated on PS quality, given quality-control and contamination concerns with commercial dietary supplements. To achieve recommended protein intakes, the panel strongly urges consumption of high-quality protein-containing whole foods. However, when impractical, the use of PSs (20-25 g per serving or 0.25-0.3 g · kg(-1) per meal), particularly after periods of strenuous physical activity (e.g., military training, combat patrols, and exercise), is acceptable. The committee acknowledges the need for further study of protein requirements for extreme, military-specific environmental conditions and whether unique metabolic stressors associated with military service alter protein requirements for aging warfighters.

  7. Efficacy of daily and weekly iron supplementation on iron status in exclusively breast-fed infants.

    PubMed

    Yurdakök, Kadriye; Temiz, Fatih; Yalçin, S Songül; Gümrük, Fatma

    2004-05-01

    Iron deficiency anemia (IDA) remains the most prevalent nutritional deficiency in infants worldwide. The purpose of this study was to determine the efficacy of daily and weekly iron supplementation for 3 months to improve the iron status in 4-month-old, exclusively breast-fed healthy infants. Infants 4 months of age were eligible for the open, randomized controlled trial if their mothers intended to continue exclusive breast-feeding until the infants were 6 months of age. Infants or mothers with iron deficiency (ID) or IDA on admission were excluded. The infants (n = 79) were randomly assigned to three groups, the first group receiving daily (1 mg/kg daily), the second group weekly (7 mg/kg weekly), and the third group no iron supplementation. Anthropometric measurements were taken on admission and at 6 and 7 months of age. Iron status was analyzed on admission and monthly for 3 months. Both hematologic parameters and anthropometric measurements were found to be similar among the three groups during the study period. Seven infants (31.8%) in the control group, six (26.0%) in the daily group, and three (13.6%) in the weekly group developed ID or IDA (P > 0.05). Infants whose mothers had ID or IDA during the study period were more likely to develop ID or IDA independently from iron supplementation. Serum ferritin levels decreased between 4 and 6 months of age in the control and daily groups; the weekly group showed no such decrease. In all groups, the mean levels of serum ferritin were significantly increased from 6 months to 7 months of age during the weaning period. In this study, which had a limited number of cases, weekly or daily iron supplementation was not found to decrease the likelihood of IDA. In conclusion, exclusively breast-fed infants with maternal IDA appeared to be at increased risk of developing IDA.

  8. Expectancy, self-efficacy, and placebo effect of a sham supplement for weight loss in obese subjects

    PubMed Central

    Tippens, Kimberly M; Purnell, Jonathan Q; Gregory, William L; Connelly, Erin; Hanes, Douglas; Oken, Barry; Calabrese, Carlo

    2014-01-01

    This study examined the role of expectancy in the placebo effect of a sham dietary supplement for weight loss in 114 obese adults. All participants received lifestyle education and were randomized to one of three conditions: 1) a daily placebo capsule and told that they were taking an active weight loss supplement; 2) daily placebo and told they had a 50% random chance of receiving either the active or placebo; or 3) no capsules. At 12 weeks, weight loss and metabolic outcomes were similar among the three groups. Participants in both groups that took capsules showed decreased weight loss self-efficacy and increased expectations of benefit from dietary supplements. Participants not taking capsules showed the opposite. Adverse events were more frequently reported in groups taking capsules than those who were not. These findings suggest that supplements without weight loss effects may have nocebo effects through diminished self-efficacy. PMID:24695007

  9. Expectancy, Self-Efficacy, and Placebo Effect of a Sham Supplement for Weight Loss in Obese Adults.

    PubMed

    Tippens, Kimberly M; Purnell, Jonathan Q; Gregory, William L; Connelly, Erin; Hanes, Douglas; Oken, Barry; Calabrese, Carlo

    2014-07-01

    This study examined the role of expectancy in the placebo effect of a sham dietary supplement for weight loss in 114 obese adults with metabolic syndrome. All participants received lifestyle education and were randomized to 1 of 3 conditions: (1) a daily placebo capsule and told that they were taking an active weight loss supplement, (2) daily placebo and told they had a 50% random chance of receiving either the active or placebo, or (3) no capsules. At 12 weeks, weight loss and metabolic outcomes were similar among the 3 groups. Participants in both groups that took capsules showed decreased weight loss self-efficacy and increased expectations of benefit from dietary supplements. Participants not taking capsules showed the opposite. Adverse events were more frequently reported in groups taking capsules than those who were not. These findings suggest that supplements without weight loss effects may have nocebo effects through diminished self-efficacy.

  10. [Efficacy evaluation of an oral powder supplement enriched with eicosapentaenoic acid in cancer patients].

    PubMed

    Gómez-Candela, C; Villarino Sanz, M; Horrisberger, A; Loria Kohen, V; Bermejo, L M; Zamora Auñón, P

    2011-01-01

    The beneficial effect of eicosapentaenoic acid in cancer patients is widely described especially in relation to its role in tumour cachexia. The aim of the study was to evaluate the efficacy of administration of a new oral powder supplement enriched with eicosapentaenoic acid compared to a standard liquid supplement in cancer patients. A total of 61 cancer patients, aged more than 18 years, were randomized to receive during a month a bonus of 600 kcal/ day to their regular diet with an oral powder supplement enriched with eicosapentaenoic acid (1.5 g) (RSI) or with a standard liquid supplement (RE). The following data were collected at baseline and after one month: the Patient-Generated Subjective Global Assessment (pg-SGA), anthropometric measurements (skin folds, circumferences and bioimpedance), dietary parameters (3-day food record), biochemical and inflammatory parameters (basic biochemistry, cytokines, prealbumin and Reactive C Protein). Quality of life was evaluated using the SF-36 questionnaire. At the end, scales were used to asses sensory perception, tolerance and satiety induced by the products and motivation to eat. 40 patients completed the study. After intervention, anthropometric parameters do not change and prealbumin values increased significantly in both groups (RSI 16.11 ± 5.66 mg/dl vs. 19.81 ± 6.75 mg/dl p < 0.05 and RE 6.13 ± 16.55 mg/dl vs. 19.03 ± 5.47 mg / dl p < 0.05). RSI group significantly decreased interferon gamma (INF-γ) values (0.99 ± 0.95 vs. 0.65 ± 0.92 pg/ml, p < 0.05). In contrast, RE group increased INF-γ after intervention (1.62 ± 1 27 vs. 2.2 ± 3.19 pg/ml, p < 0.05). There were no significant differences in hunger, appetite, satiety and intake capacity in both groups. The SF-36 scores improved in both groups. Supplementation based on an oral powder formula enriched with 1.5 g EPA during one month in cancer patients improved certain inflammatory parameters. This product may be a novel and valuable option to be added

  11. Efficacy of an oral hyaluronate and collagen supplement as a preventive treatment of elbow dysplasia

    PubMed Central

    García-López, Núria; Díaz-Ramos, Ana

    2014-01-01

    One hundred and five Labrador dogs were randomly divided into two groups to determine the number of animals that develop elbow dysplasia when treated with an oral supplement compared to untreated ones. Efficacy of the oral treatment was also evaluated once illness was diagnosed. The supplement (Hyaloral) contained hyaluronic acid, hydrolysed collagen, glucosamine, chondroitin sulphate, and gamma oryzanol. Clinical evaluation of the elbow joints was completed at months 3, 6, 12, and 20 by orthopaedic evaluations, radiography, serologic and blood analysis, and veterinarian evaluation of dysplasia symptoms. All side effects were recorded. In the control group, 33.3% of the dogs developed radiographic evidence of elbow dysplasia compared to 18.5% in the treated group. Symptoms of dysplasia at 12 months differed between the treated (12.5%) and control (61.5%) animals, and were significantly different at 20 months (p < 0.05). Differences in lameness along with movement and swelling of the elbows between groups were observed after 12 months. The treated group had improved significantly by the last visit (p < 0.05). No adverse side effects were reported. In conclusion, oral treatment with Hyaloral may have a potential cumulative action that provides protection against dysplasia and significantly improves symptoms of elbow dysplasia. PMID:25234322

  12. Efficacy of an oral hyaluronate and collagen supplement as a preventive treatment of elbow dysplasia.

    PubMed

    Martí-Angulo, Simón; García-López, Núria; Díaz-Ramos, Ana

    2014-12-01

    One hundred and five Labrador dogs were randomly divided into two groups to determine the number of animals that develop elbow dysplasia when treated with an oral supplement compared to untreated ones. Efficacy of the oral treatment was also evaluated once illness was diagnosed. The supplement (Hyaloral) contained hyaluronic acid, hydrolysed collagen, glucosamine, chondroitin sulphate, and gamma oryzanol. Clinical evaluation of the elbow joints was completed at months 3, 6, 12, and 20 by orthopaedic evaluations, radiography, serologic and blood analysis, and veterinarian evaluation of dysplasia symptoms. All side effects were recorded. In the control group, 33.3% of the dogs developed radiographic evidence of elbow dysplasia compared to 18.5% in the treated group. Symptoms of dysplasia at 12 months differed between the treated (12.5%) and control (61.5%) animals, and were significantly different at 20 months (p < 0.05). Differences in lameness along with movement and swelling of the elbows between groups were observed after 12 months. The treated group had improved significantly by the last visit (p < 0.05). No adverse side effects were reported. In conclusion, oral treatment with Hyaloral may have a potential cumulative action that provides protection against dysplasia and significantly improves symptoms of elbow dysplasia.

  13. Efficacy of a Tier 2 Supplemental Root Word Vocabulary and Decoding Intervention with Kindergarten Spanish-Speaking English Learners

    ERIC Educational Resources Information Center

    Nelson, J. Ron; Vadasy, Patricia F.; Sanders, Elizabeth A.

    2011-01-01

    The purpose of this study was to test the efficacy of a Tier 2 standard protocol supplemental intervention designed simultaneously to develop root word vocabulary and reinforce decoding skills being taught to all students in the core beginning reading program with kindergarten Spanish-speaking English learners (ELs). Participating students were…

  14. Efficacy of Supplementation with B Vitamins for Stroke Prevention: A Network Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Dong, Hongli; Pi, Fuhua; Ding, Zan; Chen, Wei; Pang, Shaojie; Dong, Wenya; Zhang, Qingying

    2015-01-01

    Supplementation with B vitamins for stroke prevention has been evaluated over the years, but which combination of B vitamins is optimal for stroke prevention is unclear. We performed a network meta-analysis to assess the impact of different combinations of B vitamins on risk of stroke. A total of 17 trials (86 393 patients) comparing 7 treatment strategies and placebo were included. A network meta-analysis combined all available direct and indirect treatment comparisons to evaluate the efficacy of B vitamin supplementation for all interventions. B vitamin supplementation was associated with reduced risk of stroke and cerebral hemorrhage. The risk of stroke was lower with folic acid plus vitamin B6 as compared with folic acid plus vitamin B12 and was lower with folic acid plus vitamin B6 plus vitamin B12 as compared with placebo or folic acid plus vitamin B12. The treatments ranked in order of efficacy for stroke, from higher to lower, were folic acid plus vitamin B6 > folic acid > folic acid plus vitamin B6 plus vitamin B12 > vitamin B6 plus vitamin B12 > niacin > vitamin B6 > placebo > folic acid plus vitamin B12. B vitamin supplementation was associated with reduced risk of stroke; different B vitamins and their combined treatments had different efficacy on stroke prevention. Folic acid plus vitamin B6 might be the optimal therapy for stroke prevention. Folic acid and vitamin B6 were both valuable for stroke prevention. The efficacy of vitamin B12 remains to be studied.

  15. The Efficacy of Supplemental Early Literacy Instruction by Community-Based Tutors for Preschoolers Enrolled in Head Start

    ERIC Educational Resources Information Center

    Nelson, J. Ron; Sanders, Elizabeth A.; Gonzalez, Jorge

    2010-01-01

    The purpose of the current study was to test the efficacy of a supplemental phonological awareness focused intervention delivered by community-based paraeducators with preschool children (M = 4.73 years) in eight Head Start classrooms in the rural Midwest. Participating children were randomly assigned to small groups within classrooms, which were…

  16. The efficacy of vitamin D supplementation during a prolonged submarine patrol.

    PubMed

    Gasier, Heath G; Gaffney-Stomberg, Erin; Young, Colin R; McAdams, Douglas C; Lutz, Laura J; McClung, James P

    2014-09-01

    Submariners spend prolonged periods submerged without sunlight exposure and may benefit from vitamin D supplementation to maintain vitamin D status. The primary objective of this study was to determine the efficacy of daily vitamin D supplementation on maintenance of 25-hydroxyvitamin D (25(OH)D) during a 3-month submarine patrol. Submariners were randomly divided into three groups: placebo (n = 16), 1,000 IU/day (n = 20), or 2,000 IU/day (n = 17). Anthropometrics, self-reported dietary calcium and vitamin D intake, serum markers of vitamin D and bone metabolism, and peripheral quantitative computed tomography (pQCT) parameters of the tibia were determined before and after the patrol. Prior to departure, 49 % of the subjects were vitamin D insufficient (<50 nmol/L). Following the patrol, 25(OH)D increased in all groups (p < 0.001): 3.3 ± 13.1 (placebo), 4.6 ± 11.3 (1,000 IU/day), and 13 ± 14 nmol/L (2,000 IU/day). The changes in 25(OH)D levels were dependent upon the baseline concentration of 25(OH)D and body mass (p < 0.001). Osteocalcin increased by 38 % (p < 0.01), and pQCT analyses revealed small, yet significant increases in indices of tibial structure and strength (p < 0.05) that were independent of supplementation. These data suggest that vitamin D status was low prior to the patrol, and the subsequent changes in vitamin D status were dependent on the baseline 25(OH)D levels and body mass. Furthermore, short-term skeletal health does not appear to be negatively affected by 3 months of submergence in spite of a suboptimal response to vitamin D supplementation.

  17. Confidence in the efficacy and safety of dietary supplements among United States active duty army personnel

    PubMed Central

    2012-01-01

    Background United States Army Soldiers regularly use dietary supplements (DS) to promote general health, enhance muscle strength, and increase energy, but limited scientific evidence supports the use of many DS for these benefits. This study investigated factors associated with Soldiers’ confidence in the efficacy and safety of DS, and assessed Soldiers’ knowledge of federal DS regulatory requirements. Methods Between 2006 and 2007, 990 Soldiers were surveyed at 11 Army bases world-wide to assess their confidence in the effectiveness and safety of DS, knowledge of federal DS regulations, demographic characteristics, lifestyle-behaviors and DS use. Results A majority of Soldiers were at least somewhat confident that DS work as advertised (67%) and thought they are safe to consume (71%). Confidence in both attributes was higher among regular DS users than non-users. Among users, confidence in both attributes was positively associated with rank, self-rated diet quality and fitness level, education, and having never experienced an apparent DS-related adverse event. Fewer than half of Soldiers knew the government does not require manufacturers to demonstrate efficacy, and almost a third incorrectly believed there are effective pre-market federal safety requirements for DS. Conclusions Despite limited scientific evidence supporting the purported benefits and safety of many popular DS, most Soldiers were confident that DS are effective and safe. The positive associations between confidence and DS use should be considered when developing DS-related interventions or policies. Additionally, education to clarify Soldiers’ misperceptions about federal DS safety and efficacy regulations is warranted. PMID:23051046

  18. Efficacy and safety of Chlorella supplementation in adults with chronic hepatitis C virus infection

    PubMed Central

    Azocar, Jose; Diaz, Arley

    2013-01-01

    AIM: To evaluate the safety and efficacy of Chlorella in 18 patients chronically infected with hepatitis C virus (HCV) genotype 1. METHODS: Eighteen adults with chronic infection by HCV genotype 1 received daily oral supplementation of Chlorella for 12 wk. Changes in the RNA levels of HCV, as well as those of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were evaluated following this treatment period. Paired t tests were conducted to compare the means of the different variables at the beginning and end of the study. Side effects and quality of life aspects were also compared between weeks 0 and 12 of the study period. RESULTS: A majority 84.61% of the patients had a significant decrease in their ALT levels from week 0 to week 12. Evaluation of side effects showed that Chlorella was well tolerated. Quality of life assessment showed that 76.9 of the participants reported an improvement in their energy levels and 46.1% reported an improvement in their perception of general health. Although 69.23% also showed a decrease in their AST levels, this was not statistically significant. Most patients that exhibited an improvement in their ALT and AST levels also showed a tendency toward a decreased HCV viral load. The HCV RNA levels showed a decrease in 69.23% of the patients, which along with changes in AST/ALT ratios from week 0 to week 12, these results were not statistically significant. CONCLUSION: Chlorella supplementation was well tolerated in patients with chronic HCV and associated with a significant decrease in ALT liver enzyme levels. PMID:23467073

  19. [Comparison of the efficacy of two different iron supplements for anemia prevention in piglets].

    PubMed

    Vermeer, J E M; Kuijpers, A H C; Elbers, A R W

    2002-02-15

    In a randomized, confirmatory study performed between July and October 2000 the efficacy of two iron products in preventing iron deficiency anaemia was compared. A total of 102 newborn piglets from ten litters were treated intramuscularly with 200 mg iron as iron dextran per ml, or 200 mg iron as gleptoferron per ml. For true comparison, piglets within a litter of a sow were subdivided into pairs on the basis of birth weight (one pair of the two heaviest piglets, et cetera). Within a pair, treatment with the iron supplements was randomly allocated. One group of piglets was injected at an age of 1 day (experiment 1) and the other group of piglets was injected at an age of 3 days (experiment 2). The piglets were weighed and blood samples were taken at an age of 18 days (experiment 1) or at an age of 19 days (experiment 2). Average daily weight gain and haemoglobin concentrations of both treatment groups were compared. Both products were very effective in preventing anaemia. No significant differences could be found between the two formulations. It can be concluded that iron-dextran and gleptoferron can be used with similar effect for anaemia prevention in piglets.

  20. Efficacy of dietary supplementation with botanicals on carbohydrate metabolism in humans.

    PubMed

    Cefalu, William T; Ye, Jianping; Wang, Zhong Q

    2008-06-01

    Botanical products are widely used in nutritional supplementation for promotion of health or prevention of diseases. With the high prevalence of obesity and type 2 diabetes, abnormalities in carbohydrate metabolism are common in the general population and obtaining glycemic control is important in reducing the complications of diabetes. If shown to be effective, botanical products have a unique position in potentially aiding the general public in regard to obesity and diabetes. They can be obtained "over-the-counter" and may have less side effects compared to many synthetic drugs. Although most of the popular botanicals have a long history in folk medicine, there is paucity of data regarding their efficacy and safety, particularly as it relates to human studies. In this review, we discuss the data that was available in the literature for nine botanicals that are frequently promoted to help manage blood glucose. They are Bitter Melon (Momordica charantia), Fenugreek (trigonella foenum graecum), Gymnema Sylvestre, Ivy Gourd (Coccinia indica), Nopal or Prickly Pear Cactus (Opuntia streptacantha), Ginseng, Aloe Vera, Russian Tarragon (Artemisia dracunculus), and Garlic (Allium sativum). The discussion is emphasized on the clinical aspect of these botanicals. Due to the lack of sufficient evidence from clinical studies for any of the botanicals reviewed, it is premature to actively recommend use of any particular herb to treat either glucose or other risk factors. Thus, well defined randomized clinical trials are warranted in this area.

  1. Efficacy of some antioxidants supplementation in reducing oxidative stress post sodium tungstate exposure in male wistar rats.

    PubMed

    Sachdeva, S; Flora, S J S

    2014-04-01

    This study aimed to evaluate the protective efficacy of some antioxidants against sodium tungstate induced oxidative stress in male wistar rats. Animals were sub-chronically exposed to sodium tungstate (100ppm in drinking water) for three months except for control group. In the same time, many rats were supplemented orally with different antioxidants (alpha-lipoic acid (ALA), n-acetylcysteine (NAC), quercetin or naringenin (0.30mM)) for five consecutive days a week for the same mentioned period before. Exposure to sodium tungstate significantly (P<0.05) inhibit blood δ-aminolevulinic acid dehydratase (ALAD) activity, liver and blood reduced glutathione (GSH) levels and an increase in oxidized glutathione (GSSG) and thiobarbituric acid reactive species (TBARS) levels in tissues. ALA acid and NAC supplementation post sodium tungstate exposure increased GSH and also, was beneficial in the recovery of altered superoxide dismutase and catalase activity, besides, significantly reducing blood and tissue reactive oxygen species and TBARS levels. The results suggest a more pronounced efficacy of ALA acid and NAC supplementation than quercetin or naringenin supplementation post sodium tungstate exposure in preventing induced oxidative stress in rats.

  2. Review: efficacy of alginate supplementation in relation to appetite regulation and metabolic risk factors: evidence from animal and human studies.

    PubMed

    Georg Jensen, M; Pedersen, C; Kristensen, M; Frost, G; Astrup, A

    2013-02-01

    This review provides a critical update on human and animal studies investigating the effect of alginate supplementation on appetite regulation, glycaemic and insulinemic responses, and lipid metabolism with discussion of the evidence on potential mechanisms, efficacy and tolerability. Dependent on vehicle applied for alginate supplementation, the majority of animal and human studies suggest that alginate consumption does suppress satiety and to some extent energy intake. Only one long-term intervention trial found effects on weight loss. In addition, alginates seem to exhibit beneficial influence on postprandial glucose absorption and insulin response in animals and humans. However, alginate supplementation was only found to have cholesterol-lowering properties in animals. Several mechanisms have been suggested for the positive effect observed, which involve delayed gastric emptying, increased viscosity of digesta and slowed nutrient absorption in the small intestine upon alginate gel formation. Despite reasonable efficacy and tolerability from the acute or short-term studies, we still realize there is a critical need for development of optimal alginate types and vehicles as well as studies on further long-term investigation on alginate supplementation in humans before inferring that it could be useful in the management of obesity and the metabolic syndrome.

  3. Nutritional supplement use by elite young UK athletes: fallacies of advice regarding efficacy

    PubMed Central

    Petróczi, Andrea; Naughton, Declan P; Pearce, Gemma; Bailey, Richard; Bloodworth, Andrew; McNamee, Michael

    2008-01-01

    Background The objective was to study nutritional supplement use among young elite UK athletes to establish whether a rationale versus practice incongruence exists, and to investigate the sources of information. Survey data were analysed for association between supplements used and motives for using such substances among young athletes along with the sources of advice and literature precedents on supplement effects. Methods Participants were elite UK male and female athletes, within the age range between 12 and 21 (n = 403), mean age 17.66 ± 1.99. Associations between type of supplements and reasons for using supplements were tested by calculating Pearson's χ2 and the strength of these symmetric associations shown by phi (ϕ) association coefficients. Results Single supplement use was reported by 48.1%, with energy drinks being the most popular, consumed by 41.7% of all athletes and 86.6% of the supplement users in the sample. No agreement was observed between athletes' rationale and behaviour in relation to nutritional supplements except for creatine. Among health professionals, nutritionists and physiotherapists, followed by coaches, were most frequently consulted. Answers regarding reasons and supplements used showed incongruence and suggest widespread misinformation regarding supplements and their effects is an issue for the young athlete. Conclusion Widespread supplement taking behaviour was evidenced in the young elite athlete population with the most notable congruence between rationale and practice among young athletes being performance-related. Young athletes in the present sample appear to be less 'health conscious' and more 'performance focused' than their adult counterparts. Further research, using a full list of supplements, is warranted to test the hypothesis that health consciousness is less dominant in supplement choice by young athletes. PMID:19077317

  4. Efficacy of Lactic Acid Bacteria (LAB) supplement in management of constipation among nursing home residents

    PubMed Central

    2010-01-01

    Background Constipation is a significant problem in the elderly, specifically nursing home and/or extended-care facility residents are reported to suffer from constipation. Lactic acid bacteria (LAB) are beneficial probiotic organisms that contribute to improved nutrition, microbial balance, and immuno-enhancement of the intestinal tract, as well as diarrhea and constipation effect. The objective of this study was to investigate the efficacy of this LAB supplement in the management of nursing home residents. Methods Nineteen subjects (8M, 11F; mean age 77.1 ± 10.1) suffering with chronic constipation were assigned to receive LAB (3.0 × 1011 CFU/g) twice (to be taken 30 minutes after breakfast and dinner) a day for 2 weeks in November 2008. Subjects draw up a questionnaire on defecation habits (frequency of defecation, amount and state of stool), and we collected fecal samples from the subjects both before entering and after ending the trial, to investigate LAB levels and inhibition of harmful enzyme activities. Results were tested with SAS and Student's t-test. Results Analysis of questionnaire showed that there was an increase in the frequency of defecation and amount of stool excreted in defecation habit after LAB treatment, but there were no significant changes. And it also affects the intestinal environment, through significantly increase (p < 0.05) fecal LAB levels. In addition, tryptophanase and urease among harmful enzyme activities of intestinal microflora were significantly decreased (p < 0.05) after LAB treatment. Conclusion LAB, when added to the standard treatment regimen for nursing home residents with chronic constipation, increased defecation habit such as frequency of defecation, amount and state of stool. So, it may be used as functional probiotics to improve human health by helping to prevent constipation. PMID:20137076

  5. Efficacy and safety of creatine supplementation in juvenile dermatomyositis: A randomized, double-blind, placebo-controlled crossover trial.

    PubMed

    Solis, Marina Yazigi; Hayashi, Ana Paula; Artioli, Guilherme Giannini; Roschel, Hamilton; Sapienza, Marcelo Tatit; Otaduy, Maria Concepción; De Sã Pinto, Ana Lucia; Silva, Clovis Artur; Sallum, Adriana Maluf Elias; Pereira, Rosa Maria R; Gualano, Bruno

    2016-01-01

    It has been suggested that creatine supplementation is safe and effective for treating idiopathic inflammatory myopathies, but no pediatric study has been conducted to date. The objective of this study was to examine the efficacy and safety of creatine supplementation in juvenile dermatomyositis (JDM) patients. In this study, JDM patients received placebo or creatine supplementation (0.1 g/kg/day) in a randomized, crossover, double-blind design. Subjects were assessed at baseline and after 12 weeks. The primary outcome was muscle function. Secondary outcomes included body composition, aerobic conditioning, health-related quality of life, and muscle phosphocreatine (PCr) content. Safety was assessed by laboratory parameters and kidney function measurements. Creatine supplementation did not affect muscle function, intramuscular PCr content, or any other secondary outcome. Kidney function was not affected, and no side effects were reported. Twelve weeks of creatine supplementation in JDM patients were well-tolerated and free of adverse effects, but treatment did not affect muscle function, intramuscular PCr, or any other parameter. © 2015 Wiley Periodicals, Inc.

  6. Confidence in the Efficacy and Safety of Dietary Supplements Among United States Active Duty Army Personnel

    DTIC Science & Technology

    2012-10-10

    including vitamins, minerals, combination products, antioxidants, herbals , protein and amino acid supplements , and purported steroid analogs) and...rarely or never” harm the user. Likewise, individuals who use herbal supplements or OTC weight-loss aids were found to be more likely to perceive...Sun C, Willsie SK: Herbal products and dietary supplements : a survey of use, attitudes, and knowledge among older adults. J Am Osteopath Assoc 2007

  7. Efficacy of daily vs. weekly supplementation of iron in schoolchildren with low iron status.

    PubMed

    Siddiqui, Imran Akhtar; Rahman, M Ataur; Jaleel, Anila

    2004-10-01

    Iron deficiency anemia (IDA) is still a major nutritional and public health problem in developing countries. The prevalence among young children and pregnant women is particularly high. Daily oral supplementation with medicinal iron is considered an effective strategy for reducing the incidence of IDA but non-compliance is a major problem with this strategy. We undertook this study to compare the results of once-weekly vs. daily oral iron supplementation in schoolchildren. Sixty children ranging between 5 and 10 years with iron deficiency anemia were selected from a school in Karachi, Pakistan and were divided into two equal groups, i.e., daily and weekly supplementation groups. Hemoglobin (Hb), hematocrit (Hct), serum iron, total iron binding capacity (TIBC), and serum ferritin were determined before the start of the study. Ferrous sulfate (200 mg) was given daily to the daily supplementation group and once-weekly to the weekly supplementation group for 2 months. When post-supplementation values of the above-mentioned parameters were determined, a significant improvement was observed in all parameters in both groups. It is concluded that once-weekly iron supplementation is as effective as daily supplementation for the treatment of iron deficiency anemia. Moreover, weekly iron supplementation is cost effective and has no or fewer side-effects.

  8. 30 CFR 250.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... revise your approved EP, DPP, or DOCD when you propose to: (1) Change the type of drilling rig (e.g., jack-up, platform rig, barge, submersible, semisubmersible, or drillship), production facility...

  9. Vitamin D Status and Efficacy of Vitamin D Supplementation in Atopic Dermatitis: A Systematic Review and Meta-Analysis

    PubMed Central

    Kim, Min Jung; Kim, Soo-Nyung; Lee, Yang Won; Choe, Yong Beom; Ahn, Kyu Joong

    2016-01-01

    Recent literature has highlighted the possible role of vitamin D in atopic dermatitis (AD), and that vitamin D supplementation might help to treat AD. This study determined the relationship between vitamin D level and AD, and assessed the efficacy of vitamin D supplementation. We searched the MEDLINE, EMBASE, and Cochrane databases up to May 2015. Observational studies and randomized controlled trials were included based on the available data on the serum 25-hydroxyvitamin D (25(OH)D) level and quantified data available for severity assessed using the Scoring Atopic Dermatitis (SCORAD) index or Eczema Area and Severity Index (EASI) score. Compared with healthy controls, the serum 25(OH)D level was lower in the AD patients of all ages (standardized mean difference = −2.03 ng/mL; 95% confidence interval (CI) = −2.52 to −0.78), and predominantly in the pediatric AD patients (standardized mean difference = −3.03 ng/mL; 95% CI = −4.76 to −1.29). In addition, the SCORAD index and EASI score decreased after vitamin D supplementation (standardized mean difference = −5.85; 95% CI = −7.66 to −4.05). This meta-analysis showed that serum vitamin D level was lower in the AD patients and vitamin D supplementation could be a new therapeutic option for AD. PMID:27918470

  10. 75 FR 35044 - Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-21

    ... Application; Penicillin G Procaine Suspension AGENCY: Food and Drug Administration, HHS. ACTION: Notice... for a revised formulation of penicillin G procaine injectable suspension that includes lecithin as a... 6JP, Northern Ireland, filed a supplement to NADA 065-010 for use of NOROCILLIN (penicillin G...

  11. Efficacy and safety of dietary supplements containing CLA for the treatment of obesity: evidence from animal and human studies.

    PubMed

    Larsen, Thomas M; Toubro, Soren; Astrup, Arne

    2003-12-01

    Dietary supplements containing conjugated linoleic acid (CLA) are widely promoted as weight loss agents available over the counter and via the Internet. In this review, we evaluate the efficacy and safety of CLA supplementation based on peer-reviewed published results from randomized, placebo-controlled, human intervention trials lasting more than 4 weeks. We also review findings from experimental studies in animals and studies performed in vitro. CLA appears to produce loss of fat mass and increase of lean tissue mass in rodents, but the results from 13 randomized, controlled, short-term (<6 months) trials in humans find little evidence to support that CLA reduces body weight or promotes repartitioning of body fat and fat-free mass in man. However, there is increasing evidence from mice and human studies that the CLA isomer trans-10, cis-12 may produce liver hypertrophy and insulin resistance via a redistribution of fat deposition that resembles lipodystrophy. CLA also decreases the fat content of both human and bovine milk. In conclusion, although CLA appears to attenuate increases in body weight and body fat in several animal models, CLA isomers sold as dietary supplements are not effective as weight loss agents in humans and may actually have adverse effects on human health.

  12. Folate/folic acid knowledge, intake, and self-efficacy of college-aged women: impact of text messaging and availability of a folic acid-containing supplement.

    PubMed

    Rampersaud, Gail C; Sokolow, Andrew; Gruspe, Abigail; Colee, James C; Kauwell, Gail P A

    2016-01-01

    To evaluate the impact of educational text messages (TMs) on folate/folic acid knowledge and consumption among college-aged women, and to evaluate the impact of providing folic acid supplements on folate/folic acid intake among college-aged women. A total of 162 women (18-24 years) recruited from a university. The protocol included 3 study visits and a 6-week intervention for 4 groups: control; TM only; supplement only; and TM+supplement. Supplement groups received folic acid-containing supplements. TM groups received 18 folate-related TMs. Participants completed knowledge quizzes, supplement intake questions, a self-efficacy scale, and dietary recalls. Despite receiving the same folic acid education, intake of folic acid and total folate was greater in the supplement groups compared with the non-supplement groups at mid- and post-study. TMs had no impact on any study measure. Provision of a folic acid-containing supplement enhanced short-term folic acid intake, supporting the provision of supplements to this population group.

  13. Efficacy of progesterone supplementation during early pregnancy in cows: A meta-analysis.

    PubMed

    Yan, Leyan; Robinson, Robert; Shi, Zhendan; Mann, George

    2016-05-01

    Progesterone is a critical hormone during early pregnancy in the cow. As a result, a number of studies have investigated the effects of progesterone supplementation on pregnancy rates. In this study, a meta-analysis using a univariate binary random effects model was carried out on 84 specific treatments reported in 53 publications involving control (n = 9905) and progesterone-treated (n = 9135) cows. Although the results of individual studies showed wide variations (-40% to +50% point changes), progesterone treatment resulted in an overall increase in pregnancy rate odds ratio (OR = 1.12; P < 0.01). Improvements in pregnancy rate were only observed in cows treated at natural estrus (OR = 1.41, P < 0.01) and not following synchronization of estrus or ovulation. Although treatment between Days 3 to 7 postinsemination was beneficial (OR = 1.15; P < 0.01), treatment earlier or later than this was not. Progesterone supplementation was beneficial in cows of lower fertility (<45% control pregnancy rate) but not in cows with higher fertility. These results indicated that the benefit of progesterone supplementation on fertility of cows required exogenous progesterone supplementation to start between Day 3 to 7 and the appropriate reproductive status (i.e., lower fertility, natural estrus) of the treated cows. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Efficacy of a Supplemental Phonemic Awareness Curriculum to Instruct Preschoolers with Delays in Early Literacy Development

    ERIC Educational Resources Information Center

    Goldstein, Howard; Olszewski, Arnold; Haring, Christa; Greenwood, Charles R.; McCune, Luke; Carta, Judith; Atwater, Jane; Guerrero, Gabriela; Schneider, Naomi; McCarthy, Tanya; Kelley, Elizabeth S.

    2017-01-01

    Purpose: Children who do not develop early literacy skills, especially phonological awareness (PA) and alphabet knowledge, prior to kindergarten are at risk for reading difficulties. We investigated a supplemental curriculum with children demonstrating delays in these skills. Method: A cluster randomized design with 104 preschool-age children in…

  15. Efficacy of a Supplemental Phonemic Awareness Curriculum to Instruct Preschoolers with Delays in Early Literacy Development

    ERIC Educational Resources Information Center

    Goldstein, Howard; Olszewski, Arnold; Haring, Christa; Greenwood, Charles R.; McCune, Luke; Carta, Judith; Atwater, Jane; Guerrero, Gabriela; Schneider, Naomi; McCarthy, Tanya; Kelley, Elizabeth S.

    2017-01-01

    Purpose: Children who do not develop early literacy skills, especially phonological awareness (PA) and alphabet knowledge, prior to kindergarten are at risk for reading difficulties. We investigated a supplemental curriculum with children demonstrating delays in these skills. Method: A cluster randomized design with 104 preschool-age children in…

  16. Confiscated black market products and nutritional supplements with non-approved ingredients analyzed in the Cologne Doping Control Laboratory 2009.

    PubMed

    Kohler, Maxie; Thomas, Andreas; Geyer, Hans; Petrou, Michael; Schänzer, Wilhelm; Thevis, Mario

    2010-01-01

    Doping control laboratories are frequently confronted with new substances that may be misused by athletes. Besides new pharmaceuticals, where method development for their detection is dependent on the availability of the substance and corresponding administration studies, some professional and amateur athletes are using illicit 'black market' products, which either differ from known pharmaceuticals but cause similar effects or still are undergoing clinical trials and are therefore rarely available to doping control laboratories. In the Cologne Doping Control Laboratory, different confiscated products and legally obtained nutritional supplements were analyzed in 2009, and various findings were reported including GH-labelled injection vials without any pharmacologically active content; combinations of products indicating the attempt to mask growth hormone abuse; unpurified long-R(3) -IGF-1; nutritional supplements containing the growth hormone releasing peptide-2 (GHRP-2); and ampoules containing the selective androgen receptor modulator Andarine (S-4). This review provides an overview on the substances that were analyzed in 2009. Ingredients relevant for doping control were identified by means of liquid chromatography and mass spectrometry methods. The awareness of new products on the black market and in nutritional supplements is of utmost importance for laboratories to develop detection methods accordingly and screen for new substances as early as possible.

  17. The Efficacy of a Pre-Workout Vegan Supplement on High-Intensity Cycling Performance in Healthy College-Aged Males.

    PubMed

    Gallien, Gabrielle; Bellar, David; Davis, Greggory R

    2017-11-02

    There is a limited supply of sport nutrition supplements currently available for vegan or vegetarian athletes. In addition, the efficacy of a vegan or vegetarian pre-workout supplement that does not contain any processed ingredients or stimulants is currently unknown. The purpose of the current study was to examine the effects of an unprocessed vegan pre-workout supplement on high-intensity cycling performance. Participants completed three separate cycling trials following the consumption of a vegan pre-workout supplement, an isocaloric processed supplement, or a zero-calorie placebo supplement. Each supplement was consumed 30 minutes prior to each trial, and each cycling trial was separated by a minimum of 72 hours. Supplements were administered using a randomized, double-blind cross-over design. Each cycling trial was performed at a workload equal to 80% VO2peak until exhaustion. The average time in seconds (s) until exhaustion values for the vegan, isocaloric, and zero-calorie supplements were 482 ± 163, 480 ± 157, and 496 ± 238, respectively. Consumption of the vegan supplement did not significantly improve performance compared to an isocaloric and zero-calorie supplement (F = 0.12, p =.89). The results of this study indicate that individuals who choose a vegan pre-workout supplement (over an isocaloric or zero-calorie product) will not experience any acute decrements or ergogenic benefits in cycling performance. Although the present study does not support performance benefits of the tested vegan pre-workout supplement before cycling, additional research examining various exercise intensities and modalities is warranted.

  18. Efficacy of Probiotic Supplementation Therapy for Helicobacter pylori Eradication: A Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Lü, Muhan; Yu, Shan; Deng, Jiaqi; Yan, Qiong; Yang, Chun; Xia, Guodong; Zhou, Xian

    2016-01-01

    Traditional Helicobacter pylori (H. pylori) eradication therapies have shown efficacies below 80% in several studies, and their use has been accompanied by antibiotic-related side effects. Some recent studies have reported that supplementing standard therapies with probiotics can improve the efficacy and tolerability of Helicobacter pylori eradication therapy. To assess the effects of probiotic supplementation on the eradication rates and therapy-related adverse event rates of anti-Helicobacter pylori regimens. We searched PubMed, Medline, the Cochrane Central Registry of Controlled Trials and the Chinese Biomedical Database for eligible randomized controlled trials published through July, 2015. Review Manager 5.3 was used for all statistical analyses. Thirteen randomized controlled trials involving a total of 2306 patients were included in our analysis. Intent-to-treat (ITT) analysis performed using a fixed-effects model (test for heterogeneity I2 = 45%) showed that the pooled relative risk (RR) of eradication was significantly higher in the probiotic supplementation group than in the control group [RR 1.15, 95% confidence interval (CI): 1.10-1.20, P<0.00001]. The incidence of total antibiotic-related side effects was lower in the probiotic supplementation group than in the control group, and the pooled RR (studies n = 9) was 0.71 (95% CI: 0.54-0.94, P = 0.02), as determined using a random-effects model (heterogeneity test I2 = 59%). Certain adverse events, such as nausea and vomiting (RR = 0.58, 95% CI 0.35-0.95, P = 0.03), diarrhea (RR = 0.51, 95% CI: 0.31-0.84, P = 0.008) and constipation (RR = 0.47, 95% CI: 0.28-0.80, P = 0.005), were reported at lower rates in the probiotic supplementation group than in the control group. Subgroup analysis showed that eradication rates were significantly improved in both adults (RR = 1.14, 95% CI: 1.09-1.19, P<0.00001) and children (RR = 1.24, 95% CI: 1.05-1.47, P = 0.01) in the probiotic supplementation group and that no

  19. Efficacy of Probiotic Supplementation Therapy for Helicobacter pylori Eradication: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Deng, Jiaqi; Yan, Qiong; Yang, Chun; Xia, Guodong; Zhou, Xian

    2016-01-01

    Background Traditional Helicobacter pylori (H. pylori) eradication therapies have shown efficacies below 80% in several studies, and their use has been accompanied by antibiotic-related side effects. Some recent studies have reported that supplementing standard therapies with probiotics can improve the efficacy and tolerability of Helicobacter pylori eradication therapy. Objective To assess the effects of probiotic supplementation on the eradication rates and therapy-related adverse event rates of anti-Helicobacter pylori regimens. Methods We searched PubMed, Medline, the Cochrane Central Registry of Controlled Trials and the Chinese Biomedical Database for eligible randomized controlled trials published through July, 2015. Review Manager 5.3 was used for all statistical analyses. Results Thirteen randomized controlled trials involving a total of 2306 patients were included in our analysis. Intent-to-treat (ITT) analysis performed using a fixed-effects model (test for heterogeneity I2 = 45%) showed that the pooled relative risk (RR) of eradication was significantly higher in the probiotic supplementation group than in the control group [RR 1.15, 95% confidence interval (CI): 1.10–1.20, P<0.00001]. The incidence of total antibiotic-related side effects was lower in the probiotic supplementation group than in the control group, and the pooled RR (studies n = 9) was 0.71 (95% CI: 0.54–0.94, P = 0.02), as determined using a random-effects model (heterogeneity test I2 = 59%). Certain adverse events, such as nausea and vomiting (RR = 0.58, 95% CI 0.35–0.95, P = 0.03), diarrhea (RR = 0.51, 95% CI: 0.31–0.84, P = 0.008) and constipation (RR = 0.47, 95% CI: 0.28–0.80, P = 0.005), were reported at lower rates in the probiotic supplementation group than in the control group. Subgroup analysis showed that eradication rates were significantly improved in both adults (RR = 1.14, 95% CI: 1.09–1.19, P<0.00001) and children (RR = 1.24, 95% CI: 1.05–1.47, P = 0.01) in

  20. Combining early postoperative parathyroid hormone and serum calcium levels allows for an efficacious selective post-thyroidectomy supplementation treatment.

    PubMed

    Raffaelli, Marco; De Crea, Carmela; Carrozza, Cinzia; D'Amato, Gerardo; Zuppi, Cecilia; Bellantone, Rocco; Lombardi, Celestino P

    2012-06-01

    Optimal treatment protocol to prevent symptomatic hypocalcemia following total thyroidectomy is still matter of debate. We prospectively evaluated the efficacy of a selective supplementation protocol based on both early postoperative intact parathyroid hormone (iPTH) and serum calcium levels. Two hundred thirty consecutive patients were divided in three different groups of treatment according to iPTH levels 4 h after total thyroidectomy (4 h-iPTH) and serum calcium levels in the first postoperative day (1PO-Ca): group A (4 h-iPTH > 10 pg/ml, 1PO-Ca ≥ 8.5 mg/dl), no treatment; group B (4 h-iPTH > 10 pg/ml, 1PO-Ca < 8.5 mg/dl), oral calcium (OC) 3 g per day; and group C (4 h-iPTH ≤ 10 pg/ml), OC 3 g + calcitriol (VD) 1 μg per day. Development of biochemical and/or symptomatic hypocalcemia was evaluated. Fifty-nine patients (25.6%) had subnormal 4 h-iPTH levels (≤10 pg/ml) (group C). Among patients with normal 4 h-iPTH levels, 25 (10.9%) had subnormal 1PO-Ca (<8.5 mg/dl) (group B). The remaining 146 patients (63.5%) had normal 4 h-iPTH and 1PO-Ca levels (group A). One patient in group A, 2 in group B, and 18 in group C developed biochemical hypocalcemia. Only one patient in group C experienced major symptoms. Treatment was discontinued within 1 month in all the patients in group B. At a mean follow-up of 303 days, five patients in group C were still under supplementation treatment. The proposed supplementation protocol seems efficacious in preventing symptomatic hypocalcemia. It could allow a safe and early discharge of most patients, thus avoiding the constraints and the costs of routine supplementation.

  1. Efficacy and Interaction of Antioxidant Supplements as Adjuvant Therapy in Cancer Treatment: A Systematic Review.

    PubMed

    Yasueda, Asuka; Urushima, Hayato; Ito, Toshinori

    2016-03-01

    Oxidative stress is a key component in carcinogenesis. Although radiation produces reactive oxygen species, some anticancer agents such as alkylating agents, platinum and antitumor antibiotics exert cytotoxicity by generating free radicals. Nonenzymatic exogenous antioxidants such as vitamins, minerals, and polyphenols can quench ROS activity. However, whether antioxidants alter antitumor effects during radiotherapy and some types of chemotherapy remains unclear. In the present study, we reviewed antioxidants as an adjuvant therapy for cancer patients during chemotherapy or radiotherapy. Electronic literature searches were performed to select all randomized controlled clinical trials (RCTs) in which antioxidants were administered to cancer patients along with chemotherapy or radiotherapy. Articles or abstracts written in English were included. In total, 399 reports received primary screening. Duplicated articles and those meeting the exclusion criteria (not RCT, not human, and no oral administration) were excluded. Finally, 49 reports matching the inclusion criteria were included. It was difficult to determine whether antioxidants affect treatment outcomes or whether antioxidants ameliorate adverse effects induced by chemotherapy and radiotherapy. It is desirable to use an evidence-based method to select supplements best suited to cancer patients. Although there are many opinions about risks or benefits of antioxidant supplementation, we could mostly conclude that the harm caused by antioxidant supplementation remains unclear for patients during cancer therapy, except for smokers undergoing radiotherapy. © The Author(s) 2015.

  2. The Infatuation With Biotin Supplementation: Is There Truth Behind Its Rising Popularity? A Comparative Analysis of Clinical Efficacy versus Social Popularity.

    PubMed

    Soleymani, Teo; Lo Sicco, Kristen; Shapiro, Jerry

    2017-05-01

    Biotin, also known as Vitamin B7 or vitamin H, is a water-soluble B vitamin that acts as an essential cofactor for several carboxylases involved in the cellular metabolism of fatty acids, amino acids, and gluconeogenesis. Although there exists an incredible amount of social media hype and market advertising touting its efficacy for the improvement of hair quantity and quality, biotin's efficacy for hair remains largely unsubstantiated in scientific literature. We reviewed all pertinent scientific literature regarding the efficacy of biotin supplementation for hair growth and quality improvement, and we also investigated its popularity in society defined as a function of market analytics. To date, there have been no clinical trials conducted to investigate the efficacy of biotin supplementation for the treatment of alopecia of any kind, nor has there been any randomized controlled trial to study its effect on hair quality and quantity in human subjects. Because of the lack of clinical evidence, its use to improve hair quantity or quality is not routinely recommended. However, societal infatuation with biotin supplementation is not only propagated by its glamorization in popular media, its popularity is vastly disproportionate to the insufficient clinical evidence supporting it's efficacy in hair improvement. In other words, biotin supplements are quite "in vogue", without there being any real reason to be so.

    J Drugs Dermatol. 2017;16(5):496-500.

    .

  3. Measuring the Impact of a Supplemental Civic Education Program on Students' Civic Attitude and Efficacy Beliefs

    ERIC Educational Resources Information Center

    Piñgul, Ferdinand S.

    2015-01-01

    This study examines the impact of Project Citizen Philippines, an extra-classroom civic education program, on its 3rd and 4th year high school participants' civic attitude and efficacy beliefs. Three hundred forty three participants and 107 non-participants from various public high schools in the Philippines' National Capital Region were compared…

  4. Efficacy of Systemic Vitamin C Supplementation in Reducing Corneal Opacity Resulting from Infectious Keratitis

    PubMed Central

    Cho, Yong-Wun; Yoo, Woong-Sun; Kim, Seong-Jae; Chung, In-Young; Seo, Seong-Wook; Yoo, Ji-Myong

    2014-01-01

    Abstract The objective of this study was to determine the effect of vitamin C supplementation on reducing the size of corneal opacity resulting from infectious keratitis. The study included 82 patients (82 affected eyes), admitted for infectious keratitis from January 2009 to August 2013, who were followed for more than 3 months. Patients were divided into control, oral vitamin C (3 g/d), and intravenous vitamin C (20 g/d) groups during hospitalization. Corneal opacity sizes were measured using anterior segment photographs and Image J program (version 1.27; National Institutes of Health, Jinju, South Korea) at admission, discharge, and final follow-up. The corneal opacity size used for analysis was the measured opacity size divided by the size of the whole cornea. The corneal opacity size decreased by 0.03 ± 0.10 in the oral vitamin C group, 0.07 ± 0.22 in the intravenous vitamin C group, and 0.02 ± 0.15 in the control group. Intravenous vitamin C reduced the corneal opacity size more than oral vitamin C (P = 0.043). Intravenous vitamin C produced greater reduction in corneal opacity size in younger patients (P = 0.015) and those with a hypopyon (P = 0.036). Systemic vitamin C supplementation reduced the size of corneal opacity resulting from infectious keratitis. Intravenous vitamin C was more beneficial than oral supplementation, especially in younger patients and those with hypopyon. PMID:25415664

  5. Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: protocol for a dose–response double-blinded placebo-controlled randomised trial

    PubMed Central

    Shen, Chwan-Li; Mo, Huanbiao; Yang, Shengping; Wang, Shu; Felton, Carol K; Tomison, Michael D; Soelaiman, Ima Nirwana

    2016-01-01

    Introduction Osteoporosis is a major health concern in postmenopausal women, and oxidative stress contributes to the development of bone loss. Cellular studies and ovariectomised rat model mimicking bone loss in postmenopausal women show the bone-protective effect of tocotrienols (TTs) with antioxidant capability. We aim to access the safety and efficacy of TT consumption for bone health in postmenopausal women. Methods and analysis In this 12-week randomised double-blinded placebo-controlled trial for the effects of dietary TT supplementation in postmenopausal women, postmenopausal women aged 45 years and older with at least 1 year after menopause and bone mineral density T-score at the spine and/or hip 2.5 or more below the reference values will be randomly assigned to 3 daily supplements: (1) placebo group receiving 860 mg olive oil, (2) low TT group receiving 430 mg of 70% pure TTs (containing 300 mg TT) and (3) high TT group receiving 860 mg of 70% pure TTs (600 mg TT). The primary outcome measure will be urinary N-terminal telopeptide. The secondary outcome measures will be serum bone-specific alkaline phosphatase, receptor activator of nuclear factor-κB ligand, osteoprotegerin, urinary 8-hydroxy-2’-deoxyguanosine and quality of life. At 0, 6 and 12 weeks, the following will be assessed: (1) primary and secondary outcome measures; (2) serum TT and tocopherol concentrations; (3) physical activity and food frequency questionnaires. Liver function will be monitored every 6 weeks for safety. ‘Intent-to-treat’ principle will be employed for data analysis. A model of repeated measurements with random effect error terms will be applied. Analysis of covariance, χ2 analysis and regression will be used for comparisons. Ethics and dissemination This study was approved by the Bioethics Committee of the Texas Tech University Health Sciences Center. The findings of this trial will be submitted to a peer-reviewed journal in the areas of bone or

  6. Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: protocol for a dose-response double-blinded placebo-controlled randomised trial.

    PubMed

    Shen, Chwan-Li; Mo, Huanbiao; Yang, Shengping; Wang, Shu; Felton, Carol K; Tomison, Michael D; Soelaiman, Ima Nirwana

    2016-12-23

    Osteoporosis is a major health concern in postmenopausal women, and oxidative stress contributes to the development of bone loss. Cellular studies and ovariectomised rat model mimicking bone loss in postmenopausal women show the bone-protective effect of tocotrienols (TTs) with antioxidant capability. We aim to access the safety and efficacy of TT consumption for bone health in postmenopausal women. In this 12-week randomised double-blinded placebo-controlled trial for the effects of dietary TT supplementation in postmenopausal women, postmenopausal women aged 45 years and older with at least 1 year after menopause and bone mineral density T-score at the spine and/or hip 2.5 or more below the reference values will be randomly assigned to 3 daily supplements: (1) placebo group receiving 860 mg olive oil, (2) low TT group receiving 430 mg of 70% pure TTs (containing 300 mg TT) and (3) high TT group receiving 860 mg of 70% pure TTs (600 mg TT). The primary outcome measure will be urinary N-terminal telopeptide. The secondary outcome measures will be serum bone-specific alkaline phosphatase, receptor activator of nuclear factor-κB ligand, osteoprotegerin, urinary 8-hydroxy-2'-deoxyguanosine and quality of life. At 0, 6 and 12 weeks, the following will be assessed: (1) primary and secondary outcome measures; (2) serum TT and tocopherol concentrations; (3) physical activity and food frequency questionnaires. Liver function will be monitored every 6 weeks for safety. 'Intent-to-treat' principle will be employed for data analysis. A model of repeated measurements with random effect error terms will be applied. Analysis of covariance, χ(2) analysis and regression will be used for comparisons. This study was approved by the Bioethics Committee of the Texas Tech University Health Sciences Center. The findings of this trial will be submitted to a peer-reviewed journal in the areas of bone or nutrition and international conferences. NCT02058420; results

  7. SAFETY AND EFFICACY OF HIGH DOSE DAILY VITAMIN D3 SUPPLEMENTATION IN CHILDREN AND YOUNG ADULTS WITH SICKLE CELL DISEASE

    PubMed Central

    Dougherty, Kelly A.; Bertolaso, Chiara; Schall, Joan I.; Smith-Whitley, Kim; Stallings, Virginia A.

    2015-01-01

    Suboptimal vitamin D (vitD) status (<32 ng/ml) is ubiquitous among African American children with type SS sickle cell disease (SCD-SS). The vitD supplemental dose to normalize vitD status is unknown. Five to 20-year-old African-American children with (n=21) and without (n=23) SCD-SS were randomized to vitD3 supplementation (4,000 or 7,000 IU/day) and evaluated at 6- and 12-weeks for changes in vitD and SCD status. A dose was considered unsafe if serum calcium was elevated associated with elevated serum 25 hydroxyvitamin D (25(OH)D)). At baseline 95% of subjects with SCD-SS and 87% of healthy controls had suboptimal vitD status (mean ± SD, 19.2 ± 7.2 and 22.3 ± 9.3 ng/ml, respectively). After 12-weeks supplementation, both D3 doses were safe and well tolerated. Neither group achieved the a priori efficacy criterion of 25(OH)D ≥ 32 ng/ml in >80% of subjects (45% in SCD-SS and 63% in controls). However for both subjects with SCD-SS and healthy subjects by 12-weeks, deficient (< 20 ng/ml) vitD status was eliminated only in those receiving 7,000 IU/d. For subjects with SCD-SS, by 12-weeks there was a significant (all P<0.05) increase in fetal hemoglobin, decrease in HS-CRP, and reduction in the percentage of subjects with a high platelet count. PMID:25985241

  8. Fish oil supplementation enhanced CPT-11 (irinotecan) efficacy against MCF7 breast carcinoma xenografts and ameliorated intestinal side-effects

    PubMed Central

    Hardman, W E; Moyer, M P; Cameron, I L

    1999-01-01

    The cancer chemotherapeutic efficacy of the topoisomerase I inhibitor, CPT-11 (irinotecan) is often limited by the induction of severe delayed diarrhoea. In animal studies, CPT-11 use is associated with histopathological damage to the mucosa of the small and large intestines. Results from the present study demonstrate that 60 mg CPT-11 per kg body weight (i.v. q4d × 6) halted the growth, but did not cause significant regression, of MCF7 human breast carcinoma xenografts in mice fed a diet containing 7% corn oil. However, when the diet of the MCF7-bearing mice was supplemented with 3% or 6% fish oil, the same CPT-11 treatment caused significant regression of the MCF7 xenograft. Histomorphometric analyses of intestinal mucosa of mice treated with CPT-11 and fed the diet containing 7% corn oil indicated that treatment with CPT-11 induced structural changes in the intestinal mucosa which persisted at least 5 days after the last dose of CPT-11. The intestinal mucosal architecture of mice that were treated with CPT-11 and fed the diets containing fish oil was largely unchanged from the architecture of the group of mice which did not receive CPT-11. These findings indicate that fish oil supplements may be a useful adjunct to CPT-11 treatment. © 1999 Cancer Research Campaign PMID:10507768

  9. Ascorbic acid supplementation does not improve efficacy of meso-dimercaptosuccinic acid treatment in lead-exposed suckling rats.

    PubMed

    Varnai, Veda Marija; Piasek, Martina; Blanusa, Maja; Juresa, Dijana; Sarić, Marija; Kostial, Krista

    2003-10-01

    It was suggested that ascorbic acid as a natural chelating agent can influence lead toxicokinetics and improve chelating properties of dimercaptosuccinic acid (DMSA) in adult rats. In this paper potential benefits of ascorbic acid supplementation, alone or combined with DMSA, in decreasing lead retention in suckling rats were evaluated. Such data in young mammals are not available. L-Ascorbic acid (daily dose 650 mg/kg b.wt.) and/or DMSA (daily dose 91 mg/kg b.wt.) were administered orally to suckling Wistar rats either during ongoing 8-day oral lead exposure (as acetate; daily dose 2 mg lead/kg b.wt.) or after 3-day lead exposure (total dose 12 mg lead/kg b.wt.). Lead concentrations were analysed in the carcass (skeleton), liver, kidneys and brain by atomic absorption spectrometry. By ascorbic acid supplementation lead retention was not reduced under either lead exposure condition. Lead concentration was even increased in the carcass. Treatment with DMSA under both exposure conditions significantly reduced lead in all analysed tissues. Combined treatment with ascorbic acid and DMSA during ongoing lead exposure was substantially less effective than DMSA treatment alone, and did not affect DMSA efficacy when administered after lead exposure. It was concluded that ascorbic acid administered either during or after lead exposure in suckling rats has no beneficial effect on either lead retention or DMSA chelation effectiveness.

  10. An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylamine (BMPEA), is found in multiple dietary supplements.

    PubMed

    Cohen, Pieter A; Bloszies, Clayton; Yee, Caleb; Gerona, Roy

    2016-01-01

    The amphetamine isomer β-methylphenylethylamine (BMPEA) was first synthesized in the early 1930s, but its efficacy and safety in humans has not been studied. Recently, the United States Food and Drug Administration (FDA) detected BMPEA in dietary supplements labelled as containing Acacia rigidula. Over a year after the FDA reported its findings, we analyzed Acacia rigidula dietary supplements to determine if BMPEA had been removed. Supplements were analyzed using liquid chromatography-quadrupole time-of-flight mass spectrometry. Diluted methanolic extract from each supplement was run three times and each data set obtained was analyzed using Agilent MassHunter Qualitative Analysis. The presence of BMPEA was confirmed by accurate mass, retention time and mass spectra match against a reference standard. Quantification of BMPEA was determined using an eight-point calibration curve of spiked standard to a matrix blank. Twenty-one brands of Acacia rigidula supplements were analyzed. More than half (11/21; 52.4%) of the Acacia rigidula supplement brands contained BMPEA. The stimulant was present at quantities such that consumers following recommended maximum daily servings would consume a maximum of 93.7 mg of BMPEA per day. Consumers of Acacia rigidula supplements may be exposed to pharmacological dosages of an amphetamine isomer that lacks evidence of safety in humans. The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements. Copyright © 2015 John Wiley & Sons, Ltd.

  11. A Bridge to Developing Efficacious Science Teachers of "All" Students: Community-Based Service-Learning Supplemented with Explicit Discussions and Activities about Diversity

    ERIC Educational Resources Information Center

    Cone, Neporcha

    2009-01-01

    This study explored the effects of community-based service-learning (CBSL), supplemented with discussions and activities about diversity, on the self-efficacy beliefs of preservice elementary teachers regarding equitable science teaching and learning for diverse student groups. The study was conducted with 81 preservice teachers enrolled in four…

  12. Sago supplementation for exercise performed in a thermally stressful environment: Rationale, efficacy and opportunity

    PubMed Central

    Che Jusoh, Mohd Rahimi; Stannard, Stephen R.; Mündel, Toby

    2016-01-01

    ABSTRACT Sago (Metroxylin sagu), a carbohydrate (CHO) based dietary staple of Southeast Asia is easily digestible and quickly absorbed, and thus has potential to be prescribed as an affordable pre-and post-exercise food in this part of the world. Compared to other CHO staples, research into the physiological response to sago ingestion is sparse, and only a few recent studies have investigated its value before, during, and after exercise. The purpose of this review is to describe the published literature pertaining to sago, particularly as a supplement in the peri-exercise period, and suggest further avenues of research, principally in an environment/climate which would be experienced in Southeast Asia i.e. hot/humid. PMID:28349080

  13. Randomized clinical trial: efficacy of a food supplement, TRANSITECH, on healthy individuals with mild intermittent constipation.

    PubMed

    Alexandre, Virginie; Bertin, Claire; Boubaya, Marouane; Airinei, Gheorghe; Bouchoucha, Michel; Benamouzig, Robert

    2016-09-01

    Constipation is a common disorder in the general population and can be observed in healthy individuals. A natural product leading to an increase in bowel movements and decrease in colonic transit time (CTT), without bloating, could be useful for the patient's care. To investigate the effects of TRANSITECH, a food supplement composed of plants and lactic ferments, on bowel movements, CTT and bloating. A total of 100 healthy participants, presenting two to five stools per week, were selected and followed over a 6-day baseline period. They were randomly assigned to receive daily two tablets of TRANSITECH or placebo during 10 days. They were then followed up over 28 days after intervention. Participants daily recorded in a home questionnaire the characteristics of stools (frequency and consistency), and the importance of bloating during the preintervention period (from D-6 to D0), the intervention period (from D0 to D10) and the postintervention period (from D10 to D38). Their CTTs were also evaluated by following the propagation of radiopaque markers at D0 and D10. At D10, the food supplement group showed, compared with the placebo group, higher daily stool emission (0.95±0.50, 0.70±0.20, P<0.001), softer stool consistency (2.5±0.6 vs. 3.0±0.8, P<0.001) and lower CTT (33.8±28.2 vs. 56.4±36.2 h, P=0.01). The active group also showed a sustained increase in daily stool emissions observed at D38 compared with D0 (P=0.03). TRANSITECH is an efficient natural solution for the treatment of constipation. It increases the number of bowel movements, decreases the oroanal and segmental CTT, is well tolerated, and presents sustained effects after treatment completion.

  14. Acute and chronic safety and efficacy of dose dependent creatine nitrate supplementation and exercise performance.

    PubMed

    Galvan, Elfego; Walker, Dillon K; Simbo, Sunday Y; Dalton, Ryan; Levers, Kyle; O'Connor, Abigail; Goodenough, Chelsea; Barringer, Nicholas D; Greenwood, Mike; Rasmussen, Christopher; Smith, Stephen B; Riechman, Steven E; Fluckey, James D; Murano, Peter S; Earnest, Conrad P; Kreider, Richard B

    2016-01-01

    Creatine monohydrate (CrM) and nitrate are popular supplements for improving exercise performance; yet have not been investigated in combination. We performed two studies to determine the safety and exercise performance-characteristics of creatine nitrate (CrN) supplementation. Study 1 participants (N = 13) ingested 1.5 g CrN (CrN-Low), 3 g CrN (CrN-High), 5 g CrM or a placebo in a randomized, crossover study (7d washout) to determine supplement safety (hepatorenal and muscle enzymes, heart rate, blood pressure and side effects) measured at time-0 (unsupplemented), 30-min, and then hourly for 5-h post-ingestion. Study 2 participants (N = 48) received the same CrN treatments vs. 3 g CrM in a randomized, double-blind, 28d trial inclusive of a 7-d interim testing period and loading sequence (4 servings/d). Day-7 and d-28 measured Tendo™ bench press performance, Wingate testing and a 6x6-s bicycle ergometer sprint. Data were analyzed using a GLM and results are reported as mean ± SD or mean change ± 95 % CI. In both studies we observed several significant, yet stochastic changes in blood markers that were not indicative of potential harm or consistent for any treatment group. Equally, all treatment groups reported a similar number of minimal side effects. In Study 2, there was a significant increase in plasma nitrates for both CrN groups by d-7, subsequently abating by d-28. Muscle creatine increased significantly by d-7 in the CrM and CrN-High groups, but then decreased by d-28 for CrN-High. By d-28, there were significant increases in bench press lifting volume (kg) for all groups (PLA, 126.6, 95 % CI 26.3, 226.8; CrM, 194.1, 95 % CI 89.0, 299.2; CrN-Low, 118.3, 95 % CI 26.1, 210.5; CrN-High, 267.2, 95 % CI 175.0, 359.4, kg). Only the CrN-High group was significantly greater than PLA (p < 0.05). Similar findings were observed for bench press peak power (PLA, 59.0, 95 % CI 4.5, 113.4; CrM, 68.6, 95 % CI 11.4, 125.8; CrN-Low, 40.9, 95

  15. Efficacy and safety of fortification and supplementation with vitamin B12: biochemical and physiological effects.

    PubMed

    Carmel, Ralph

    2008-06-01

    Long known as an uncommon but serious medical disorder requiring medical management, vitamin B12 deficiency is now seen to be common worldwide, but it is in a quite different form than traditionally envisioned. Most of the newly recognized deficiency is subclinical in nature, its health impact and natural history are uncertain, and its prevalence has been greatly inflated by also including persons with "low-normal" vitamin B12 levels, few of whom are deficient. The spread of folic acid fortification has also introduced concerns about folate's potentially adverse neurologic consequences in persons with undetected vitamin B12 deficiency. Fortification with vitamin B12 may prove more complicated than fortification with folic acid, however, because the bioavailability of vitamin B12 is limited. Bioavailability for those who need the vitamin B12 the most is especially poor, because they often have malabsorption affecting either classical intrinsic factor-mediated absorption or food-vitamin B12 absorption. Moreover, new evidence shows that many elderly persons respond poorly to daily oral doses under 500 microg (1 microg = 0.74 nmol), even if they do not have classical malabsorption, which suggests that proposed fortification with 1 to 10 microg may be ineffective. Those least in need of vitamin B12 usually have normal absorption and are thus at greatest risk for whatever unknown adverse effects of high-dose fortification might emerge, such as the effects of excess accumulation of cyanocobalamin. Studies are needed to define the still unproven health benefits of vitamin B12 fortification, the optimal levels of fortification, the stability of such fortification, interactions with other nutrients, and any possible adverse effects on healthy persons. The answers will permit formulation of appropriately informed decisions about mandatory fortification or (because fortification may prove a poor choice) about targeted supplementation in subpopulations with special needs for

  16. Efficacy of iron-supplement bars to reduce anemia in urban Indian women: a cluster-randomized controlled trial.

    PubMed

    Mehta, Rajvi; Platt, Alyssa C; Sun, Xizi; Desai, Mukesh; Clements, Dennis; Turner, Elizabeth L

    2017-03-01

    Background: India's high prevalence of iron-deficiency anemia has largely been attributed to the local diet consisting of nonheme iron, which has lower absorption than that of heme iron.Objective: We assessed the efficacy of the consumption of iron-supplement bars in raising hemoglobin concentrations and hematocrit percentages in anemic (hemoglobin concentration <12 g/dL) Indian women of reproductive age.Design: The Let's be Well Red study was a 90-d, pair-matched, cluster-randomized controlled trial. A total of 361 nonpregnant women (age 18-35 y) were recruited from 10 sites within Mumbai and Navi Mumbai, India. All participants received anemia education and a complete blood count (CBC). Random assignment of anemic participants to intervention and control arms occurred within 5 matched site-pairs. Intervention participants received 1 iron-supplement bar (containing 14 mg Fe)/d for 90 d, whereas control subjects received nothing. CBC tests were given at days 15, 45, and 90. Primary outcomes were 90-d changes from baseline in hemoglobin concentrations and hematocrit percentages. Linear mixed models and generalized estimating equations were used to model continuous and binary outcomes, respectively.Results: Of 179 anemic participants, 136 (76.0%) completed all follow-up assessments (65 intervention and 71 control participants). Baseline characteristics were comparable by arm. Mean hemoglobin and hematocrit increases after 90 d were greater for intervention than for control participants [1.4 g/dL (95% CI: 1.3, 1.6 g/dL) and 2.7% (95% CI: 2.2%, 3.2%), respectively]. The anemia prevalence at 90 d was lower for intervention (29.2%) than for control participants (98.6%) (OR: 0.007; 95% CI: 0.001, 0.04).Conclusions: The daily consumption of an iron-supplement bar leads to increased hemoglobin concentrations and hematocrit percentages and to a lower anemia prevalence in the target population with no reported side effects. This intervention is an attractive option to combat

  17. Efficacy of vitamins B supplementation on mild cognitive impairment and Alzheimer's disease: a systematic review and meta-analysis.

    PubMed

    Li, Meng-Meng; Yu, Jin-Tai; Wang, Hui-Fu; Jiang, Teng; Wang, Jun; Meng, Xiang-Fei; Tan, Chen-Chen; Wang, Chong; Tan, Lan

    2014-01-01

    Despite B vitamin supplementation playing an important role in cognitive function, the exact effect remains unknown. The aim of this study was to systematically review and quantitatively synthesize the efficacy of treatment with vitamins B supplementation in slowing the rate of cognitive, behavioral, functional and global decline in individuals with MCI or AD. A systematic literature search in PubMed, EMBASE, International Pharmaceutical Abstracts, clinicaltrials. gov, the Cochrane Controlled Trials Register, the Cochrane Database of Systematic Reviews, and the Cochrane Cognitive Improvement Group specialized registry was conducted on April 2014, with no limit of date. Five trials met the eligibility criteria and were selected for this meta-analysis. Meta-analysis showed moderate beneficial effects of vitamins B supplementation on memory (SMD 0.60, 95% CI 0.20, 1.00), whereas no significant difference on general cognitive function (WMD -0.10, 95% CI -0.80, 0.59), executive function (SMD 0.05, 95% CI -0.11, 0.21) and attention (WMD -0.03, 95% CI -1.20, 1.14) were found in MCI patients. In addition, no significantly cognitive benefits on the Alzheimer's Disease Assessment Scale (ADAS-cog) (WMD 1.01, 95% CI -0.68, 2.70) and Mini Mental State Examination (MMSE) (WMD -0.22, 95% CI -1.00, 0.57), functional (SMD 0.13, 95% CI -0.05, 0.31), behavioral (SMD 0.04, 95% CI -0.16, 0.25) or global (WMD 0.07, 95% CI -0.48, 0.62) change were observed in AD patients. Collectively, weak evidence of benefits was observed for the domains of memory in patients with MCI. Nevertheless, future standard RCTs are still needed to determine whether it was still significant in larger populations. However, the data does not yet provide adequate evidence of an effect of vitamins B on general cognitive function, executive function and attention in people with MCI. Similarly, folic acid alone or vitamins B in combination are unable to stabilize or slow decline in cognition, function, behavior, and

  18. A preliminary study of the safety, feasibility and cognitive efficacy of soy isoflavone supplements in older men and women

    PubMed Central

    Gleason, Carey E.; Carlsson, Cynthia M.; Barnet, Jodi H.; Meade, Sarah A.; Setchell, Kenneth D. R.; Atwood, Craig S.; Johnson, Sterling C.; Ries, Michele L.; Asthana, Sanjay

    2009-01-01

    Background: a small number of reports exist on the cognitive effects of soy isoflavones, the findings from which are mixed. Isoflavone efficacy is dependent upon conversion of glycosides contained in soy foods and supplements to the biologically active aglycons. Of particular interest is the production of the metabolite, equol, which is dependent upon intestinal microflora and an integrous digestive system, both being altered by age and age-associated conditions. Unfortunately, few studies enrolled adults over the age of 70, and none included older men. Objective: we examined safety, feasibility and cognitive efficacy of soy isoflavone administration in older nondemented men and women (age 62–89 years). Design and Methods: in this randomised, placebo-controlled, double-blind pilot study, subjects ingested either 100 mg/day soy isoflavones (glycoside weight) or matching placebo tablets for 6 months. Results: active and placebo-treated subjects exhibited a comparable side-effect profile. Plasma levels of genistein and daidzein (P < 0.001), but not equol, increased with isoflavone administration. While similar at baseline, the two groups differed across 6 months of treatment on 8 of 11 cognitive tests administered. Isoflavone-treated subjects improved on tests of visual-spatial memory (P < 0.01) and construction (P = 0.01), verbal fluency (P < 0.01) and speeded dexterity (P = 0.04). Placebo-treated participants were faster than isoflavone-treated subjects on two tests of executive function (P < 0.05). Conclusions: these data suggest that administration of 100 mg/day of isoflavones was well tolerated. Plasma genistein and daidzein levels, but not equol, increased with isoflavone administration. Finally, data support the potential cognitive effects of soy isoflavones in older adults. PMID:19054783

  19. Efficacy of supplementation of selected medicinal mushrooms with inorganic selenium salts.

    PubMed

    Niedzielski, Przemysław; Mleczek, Mirosław; Siwulski, Marek; Gąsecka, Monika; Kozak, Lidia; Rissmann, Iwona; Mikołajczak, Patrycja

    2014-01-01

    The aim of the study was to evaluate the possibility of supplementation with inorganic forms of selenium (Na2SeO4 and Na2SeO3) in concentrations of 0, 0.1, 0.2, 0.4, 0.6, 0.8, 1.0 and 1.5 mM of three medicinal mushroom species: Agrocybe aegerita, Hericium erinaceus and Ganoderma lucidum. Tested mushroom species grew in Se additions of 0-0.6 mM (A. aegerita and H. erinaceus), while growth of G. lucidum bodies was observed for 0-0.8 mM. For the latter mushroom species, the total Se content was the highest. Content of Seorg was diverse; for control bodies it was the highest for G. lucidum (only organic forms were present), lower for A. aegerita (84% organic forms) and the lowest for H. erinaceus (56% organic forms). Accumulation of Se(IV) was generally significantly higher than Se(VI) for all tested mushroom species. There was no significant decrease of A. aegerita or G. lucidum biomass with the exception of G. lucidum bodies growing under 0.8 mM of Se species addition (15.51 ± 6.53 g). Biomass of H. erinaceus bodies was the highest under 0.2 (197.04 ± 8.73 g), control (191.80 ± 6.06 g) and 0.1 mM (185.04 ± 8.73 g) of both inorganic salts. The addition to the medium of Se salts brought about macroscopic changes in the fruiting bodies of the examined mushrooms. Concentrations exceeding 0.4 mM caused diminution of carpophores or even their total absence. In addition, colour changes of fruiting bodies were also recorded. At Se concentrations of 0.4 and 0.6 mM, A. aegerita fruiting bodies were distinctly lighter and those of H. erinaceus changed colour from purely white to white-pink.

  20. Efficacy of phytosterols and fish-oil supplemented high-oleic-sunflower oil rich diets in hypercholesterolemic growing rats.

    PubMed

    Alsina, Estefania; Macri, Elisa V; Lifshitz, Fima; Bozzini, Clarisa; Rodriguez, Patricia N; Boyer, Patricia M; Friedman, Silvia M

    2016-06-01

    Phytosterols (P) and fish-oil (F) efficacy on high-oleic-sunflower oil (HOSO) diets were assessed in hypercholesterolemic growing rats. Controls (C) received a standard diet for 8 weeks; experimental rats were fed an atherogenic diet (AT) for 3 weeks, thereafter were divided into four groups fed for 5 weeks a monounsaturated fatty acid diet (MUFA) containing either: extra virgin olive oil (OO), HOSO or HOSO supplemented with P or F. The diets did not alter body weight or growth. HOSO-P and HOSO-F rats showed reduced total cholesterol (T-chol), non-high-density lipoprotein-cholesterol (non-HDL-chol) and triglycerides and increased HDL-chol levels, comparably to the OO rats. Total body fat (%) was similar among all rats; but HOSO-F showed the lowest intestinal, epididymal and perirenal fat. However, bone mineral content and density, and bone yield stress and modulus of elasticity were unchanged. Growing hypercholesterolemic rats fed HOSO with P or F improved serum lipids and fat distribution, but did not influence material bone quality.

  1. Potential efficacy of broccoli sprouts as a unique supplement for management of type 2 diabetes and its complications.

    PubMed

    Bahadoran, Zahra; Mirmiran, Parvin; Azizi, Fereidoun

    2013-05-01

    Functional foods and their nutraceutical components are now considered as supplementary treatments in type 2 diabetes and prevention of its long-term complications. Young broccoli sprouts as a functional food contain many bioactive compounds specially sulforaphane. In hyperglycemic and oxidative conditions, sulforaphane has the potential to activate the NF-E2-related factor-2 (Nrf2)-dependent antioxidant response-signaling pathway, induces phase 2 enzymes, attenuates oxidative stress, and inactivates nuclear factor kappa-B (NF-κB), a key modulator of inflammatory pathways. Interestingly, sulforaphane induces some peroxisome proliferator-activated receptors, which contribute to lipid metabolism and glucose homeostasis. In animal and in vitro models, sulforaphane also shows antihypertensive, anticancer, cardioprotective, and hypocholesterolemic capacity, and has bactericidal properties against Helicobacter pylori. Supplementation of type 2 diabetics with high sulforaphane content broccoli sprouts resulted in increased total antioxidant capacity of plasma and in decreased oxidative stress index, lipid peroxidation, serum triglycerides, oxidized low-density lipoprotein (LDL)/LDL-cholesterol ratio, serum insulin, insulin resistance, and serum high-sensitive C-reactive protein. Sulforaphane could prevent nephropathy, diabetes-induced fibrosis, and vascular complications. Potential efficacy of sulforaphane and probably other bioactive components of young broccoli sprouts makes it as an excellent choice for supplementary treatment in type 2 diabetes.

  2. Efficacy of vitamin and antioxidant supplements in prevention of cardiovascular disease: systematic review and meta-analysis of randomised controlled trials

    PubMed Central

    Ju, Woong; Oh, Seung-Won; Park, Sang Min; Koo, Bon-Kwon; Park, Byung-Joo

    2013-01-01

    Objective To assess the efficacy of vitamin and antioxidant supplements in the prevention of cardiovascular diseases. Design Meta-analysis of randomised controlled trials. Data sources and study selection PubMed, EMBASE, the Cochrane Library, Scopus, CINAHL, and ClinicalTrials.gov searched in June and November 2012. Two authors independently reviewed and selected eligible randomised controlled trials, based on predetermined selection criteria. Results Out of 2240 articles retrieved from databases and relevant bibliographies, 50 randomised controlled trials with 294 478 participants (156 663 in intervention groups and 137 815 in control groups) were included in the final analyses. In a fixed effect meta-analysis of the 50 trials, supplementation with vitamins and antioxidants was not associated with reductions in the risk of major cardiovascular events (relative risk 1.00, 95% confidence interval 0.98 to 1.02; I2=42%). Overall, there was no beneficial effect of these supplements in the subgroup meta-analyses by type of prevention, type of vitamins and antioxidants, type of cardiovascular outcomes, study design, methodological quality, duration of treatment, funding source, provider of supplements, type of control, number of participants in each trial, and supplements given singly or in combination with other supplements. Among the subgroup meta-analyses by type of cardiovascular outcomes, vitamin and antioxidant supplementation was associated with a marginally increased risk of angina pectoris, while low dose vitamin B6 supplementation was associated with a slightly decreased risk of major cardiovascular events. Those beneficial or harmful effects disappeared in subgroup meta-analysis of high quality randomised controlled trials within each category. Also, even though supplementation with vitamin B6 was associated with a decreased risk of cardiovascular death in high quality trials, and vitamin E supplementation with a decreased risk of myocardial infarction

  3. A Bridge to Developing Efficacious Science Teachers of All Students: Community-Based Service-Learning Supplemented with Explicit Discussions and Activities about Diversity

    NASA Astrophysics Data System (ADS)

    Cone, Neporcha

    2009-08-01

    This study explored the effects of community-based service-learning (CBSL), supplemented with discussions and activities about diversity, on the self-efficacy beliefs of preservice elementary teachers regarding equitable science teaching and learning for diverse student groups. The study was conducted with 81 preservice teachers enrolled in four sections of an elementary science methods course over a semester. Employing a mixed-methods research design, data were collected using pretests-posttests with the study sample and semistructured interviews with a subsample. The results support the value of preservice teachers engaging in CBSL experiences, supplemented with discussions and activities about diversity, as a way to improve their self-efficacy beliefs regarding equitable science teaching and learning of all students.

  4. Estimated cost efficacy of systemic treatments that are approved by the US Food and Drug Administration for the treatment of moderate to severe psoriasis.

    PubMed

    D'Souza, Logan S; Payette, Michael J

    2015-04-01

    Newer psoriasis treatments tout higher efficacy but are generally more expensive. We sought to estimate the cost efficacy of systemic psoriasis treatments that have been approved by the US Food and Drug Administration (FDA). A literature review of systemic psoriasis treatments that have been approved by the FDA was performed for the primary end point of a 75% reduction in the Psoriasis Area and Severity Index score (PASI 75). Medication cost was referenced by wholesale acquisition cost (WAC), laboratory fees were obtained from the American Medical Association, and office visit fees are standard at our university. Total expenses were standardized by calculating cost per month of treatment considering the number needed to treat (NNT) to achieve PASI 75. Methotrexate ($794.05-1502.51) and cyclosporine ($1410.14-1843.55) had the lowest monthly costs per NNT to achieve PASI 75. The most costly therapies were infliximab ($8704.68-15,235.52) and ustekinumab 90 mg ($12,505.26-14,256.75). Monthly costs per NNT to achieve PASI 75 for other therapies were as follows: narrowband ultraviolet B light phototherapy ($2924.73), adalimumab ($3974.61-7678.78), acitretin ($4137.71-14,148.53), ustekinumab 45 mg ($7177.89-7263.99), psoralen plus ultraviolet A light phototherapy ($7499.46-8834.98), and etanercept ($8284.71-10,674.89). Drug rebates and incentives, potential adverse effects, comorbidity risk reduction, ambassador programs, and combination therapies were excluded. Our study provides meaningful cost efficacy data that may influence psoriasis treatment selection. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  5. Adverse effects of wide calcium:phosphorus ratios on supplemental phytase efficacy for weanling pigs fed two dietary phosphorus levels.

    PubMed

    Qian, H; Kornegay, E T; Conner, D E

    1996-06-01

    Ninety-six weanling pigs (initial BW = 9.3 kg, initial age = 37 d) were used in a 4-wk experiment to evaluate the response to three Ca: total (t) P ratios (1.2:1, 1.6:1, or 2.0:1) fed in combination with two P levels (.07 or .16% available that correspond to .36 or .45% tP) and two phytase levels (PY; 700 or 1,050 units/kg of diet). A 3 x 2 x 2 factorial arrangement of treatments was employed using a corn-soybean meal diet. Performance, serum mineral concentrations and alkaline phosphatase (ALP) activity, Ca and P digestibility and excretion, and bone mechanical measurements were examined. Average daily gain (P < .001), average daily feed intake (P < .01), and gain:feed (P < .05) were decreased linearly as the Ca:tP ratio became wider. The digestibility of P and Ca were decreased (P < .001) linearly as the Ca:tP ratio became wider. The digestibility of P (P < .001) and fecal P excretion (P < .01) were increased at the higher level of P. Increasing PY from 700 to 1,050 units (U)/kg of diet increased (P < .05) P digestibility and decreased (P < .01) P excretion but did not improve bone measurements. Shear force, stress and energy, and percentage of ash of both metacarpal and 10th rib linearly decreased (P < .001 to .05) as the Ca:tP ratio became wider, and bone measurements were generally greater for pigs fed the higher P level. Serum Ca concentration increased (P < .01) and the P concentration decreased (P < .001) as the Ca:tP ratio increased, but Mg, Zn, and ALP activity were not influenced by the Ca:tP ratio. Serum Ca and P concentrations were affected by PY supplementation over the 4-wk trial, but serum Mg and Zn concentrations were not affected by dietary treatments. Adverse effects of a wide Ca:tP ratio were greater at the low P diet for all responses. In addition, the activity of supplemental PY in diets seemed to be decreased as the Ca:tP ratio became wider and this negative effect of Ca:tP ratio seemed greater at the low P level, and seemed to parallel the

  6. Safety and efficacy of US-approved viscosupplements for knee osteoarthritis: a systematic review and meta-analysis of randomized, saline-controlled trials

    PubMed Central

    Strand, Vibeke; McIntyre, Louis F; Beach, William R; Miller, Larry E; Block, Jon E

    2015-01-01

    Background Intra-articular injection of hyaluronic acid is a common, yet controversial, therapeutic option for patients with knee osteoarthritis (OA). The purpose of this research was to determine the safety and efficacy of US-approved viscosupplements for symptomatic knee OA. Methods We searched MedLine and EMBase for randomized, sham-controlled trials evaluating safety and/or clinical efficacy of US-approved viscosupplements in patients with symptomatic knee OA. Knee pain severity and knee joint function were assessed at 4 to 13 weeks and 14 to 26 weeks. Safety outcomes included serious adverse events, treatment-related serious adverse events, patient withdrawal, and adverse event-related patient withdrawal occurring at any time during follow-up. Results A total of 29 studies representing 4,866 unique patients (active: 2,673, control: 2,193) were included. All sham-controlled trials used saline injections as a control. Viscosupplementation resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to preinjection values, with standardized mean difference values ranging from 1.07 to 1.37 (all P<0.001). Compared to controls, standardized mean difference with viscosupplementation ranged from 0.38 to 0.43 for knee pain and 0.32 to 0.34 for knee function (all P<0.001). There were no statistically significant differences between viscosupplementation and controls for any safety outcome, with absolute risk differences of 0.7% (95% confidence interval [CI]: −0.2 to 1.5%) for serious adverse events, 0% (95% CI: −0.4 to 0.4%) for treatment-related serious adverse events, 0% (95% CI: −1.6 to 1.6%) for patient withdrawal, and 0.2% (95% CI: −0.4 to 0.8%) for adverse event-related patient withdrawal. Conclusion Intra-articular injection of US-approved viscosupplements is safe and efficacious through 26 weeks in patients with symptomatic knee OA. PMID:26005358

  7. Evaluation Series on Safety and Efficacy of Nutritional Supplements in Newly Diagnosed Hyperglycemia: A Placebo-Controlled, Randomized Study

    PubMed Central

    Thacker, Hemant; Bantwal, Ganapati; Jain, Sunil; Kalra, Sanjay; Kale, Shailaja; Saboo, Banshi; Gupta, Jugal B.; Sivam, Sakthivel

    2016-01-01

    Background: Diabetes is endemic with developing economies contributing to the bulk of this pandemic. Despite the evidence of incremental benefit of glycemic control starting early in life, acceptance of and adherence to modern medications remain suboptimal. Aims: To determine the hemoglobin A1c (HbA1c)-lowering efficacy and safety of nutritional supplement, PreCrea®, in adult Indians with newly diagnosed hyperglycemia. Materials and Methods: Double-blind, randomized study conducted in six diabetes centers in India. A total of 193 treatment-naïve subjects with newly diagnosed hyperglycemia and fasting plasma glucose (FPG) >100 mg/dL were randomized into either PreCrea® 600 mg (n = 90) or matched placebo (n = 89) capsules twice daily, along with lifestyle modification, for 12 weeks. The main outcomes were changes in HbA1c and FPG levels, attainment of the American Diabetes Association (ADA)-defined goals for HbA1c, and clinical and biochemical measures of safety. Results: At 12 weeks, mean HbA1c in PreCrea® group reduced by 0.91% compared with 0.08% increase in the placebo group (P < .001). The reductions in the mean FPG at week 4 (P < .001) and week 12 (P = 0.04) were significant compared to the baseline. ADA goal of HbA1c <7% increased from 15.5% at the baseline to 35.6% at week 12 in PreCrea® subjects. Clinical safety and biochemical safety did not change. Hypoglycemia and weight gain were not observed with PreCrea®. Conclusions: Nearly 1% point reduction in HbA1c at week 12 with PreCrea® is comparable with most first-line glucose-lowering drugs. The safety and tolerability of PreCrea® highlights its potential as a first-line therapy in newly detected hyperglycemia. PMID:27042609

  8. Efficacy of supplementation of alpha-amylase-producing bacterial culture on the performance, nutrient use, and gut morphology of broiler chickens fed a corn-based diet.

    PubMed

    Onderci, M; Sahin, N; Sahin, K; Cikim, G; Aydín, A; Ozercan, I; Aydín, S

    2006-03-01

    A trial was conducted to evaluate the efficacy of an Escherichia coli strain producing alpha-amylase of Bacillus stearothermophilus on growth performance, nutrient use, and the morphology of the small intestine of broilers fed a corn-based diet. One hundred thirty-five 1-d-old chicks (Cobb 500) were randomly divided into 3 groups and treated as follows: (i) basal diet (control); (ii) basal diet and water supplemented with an E. coli strain that produced amylase, and (iii) basal diet and water supplemented with an E. coli strain that produced amylase plus bacterial hemoglobin. At 21 d of age, supplementation of E. coli improved daily gain (P < 0.05) and feed conversion (P < 0.01). At the end of the trial, birds supplemented with water containing bacteria consumed more and grew faster (P < 0.05) and had better feed conversion (P < 0.10) than broilers given no bacteria. Also, the presence of bacteria improved apparent digestibility of organic matter (P < 0.01). However, no effects were detected for CP or fat digestibility. Supplementation with E. coli reduced relative pancreas weight (P = 0.06) but did not affect the weight of the liver (P > 0.05) and length of duedonum, jejunum, ileum, and cecum (P > 0.05). Length of the villi and crypts were significantly increased with bacterial supplementation. Presence of the bacterial hemoglobin gene did not cause a significant difference in changes observed. The data indicated that supplementation of an E. coli strain capable of producing alpha-amylase improved digestibility of nutrients and performance of broilers fed a corn-based diet.

  9. Drugs, Herbs and Supplements: MedlinePlus

    MedlinePlus

    ... this page: https://medlineplus.gov/druginformation.html Drugs, Herbs and Supplements To use the sharing features on ... approved labels included in drug packages, see DailyMed . Herbs and Supplements Browse dietary supplements and herbal remedies ...

  10. Pralatrexate with vitamin supplementation in patients with previously treated, advanced non-small cell lung cancer: safety and efficacy in a phase 1 trial.

    PubMed

    Azzoli, Christopher G; Patel, Jyoti D; Krug, Lee M; Miller, Vincent; James, Leonard; Kris, Mark G; Ginsberg, Michelle; Subzwari, Sara; Tyson, Leslie; Dunne, Megan; May, Jennifer; Huntington, Martha; Saunders, Michael; Sirotnak, F M

    2011-11-01

    Pralatrexate is an antifolate designed for preferential tumor cell uptake and accumulation and received accelerated Food and Drug Administration approval in relapsed/refractory peripheral T-cell lymphoma. Pralatrexate 135 to 150 mg/m(2) every 2 weeks without vitamin supplementation was active in non-small cell lung cancer (NSCLC) although mucositis was dose limiting. This phase 1 study evaluated the safety of higher pralatrexate doses with vitamin supplementation to minimize toxicities. Patients with stage IIIB/IV NSCLC received pralatrexate 150 to 325 mg/m(2) every 2 weeks with folic acid and vitamin B12 supplementation. Outcomes measured included adverse events (AEs), pharmacokinetics, and radiologic response. Thirty-nine patients were treated for a median of two cycles (range 1-16+). Common treatment-related grade 3 and 4 AEs by dose (≤190 mg/m(2) and >190 mg/m(2)) included mucositis (33 and 40%) and fatigue (11 and 17%). Treatment-related serious AE (SAE) rates for doses ≤190 and >190 mg/m(2) were 0 and 20%, respectively. The response rate was 10% (95% confidence interval: 1-20%), including two patients with complete response (26+ and 32+ months) and two with partial response. Serum pralatrexate concentrations increased dose dependently up to 230 mg/m(2). Pralatrexate with vitamin supplementation was safely administered to patients with previously treated NSCLC, and durable responses were observed. The recommended starting dose for phase 2 is 190 mg/m(2). A similar safety profile was observed in patients treated at 230 mg/m(2), although a higher serious AE rate was evident. Mucositis remains the dose-limiting toxicity of pralatrexate, and this study failed to demonstrate that vitamin supplementation prevents mucositis and failed to identify clinical predictors of mucositis. Individualized dose-modification strategies and prospective mucositis management will be necessary in future trials.

  11. Smear layer removal efficacy of combination of herbal extracts in two different ratios either alone or supplemented with sonic agitation: An in vitro scanning electron microscope study

    PubMed Central

    Chhabra, Naveen; Gyanani, Hitesh; Kamatagi, Laxmikant

    2015-01-01

    Objectives: The study aimed to evaluate the effectiveness of the combination of two natural extracts in varying ratios for removal of smear layer either alone or supplemented with sonic agitation. Materials and Methods: Fifty extracted single-rooted teeth were collected, disinfected and decoronated below the cementoenamel junction to obtain standardized root length of 10 mm. Root canals were instrumented using rotary files at working length 1 mm short of the apex. Specimens were divided into six groups according to the irrigation protocol as follows: Group A – Distilled water, Group B – 17% ethylenediaminetetraacetic acid, Group C – Herbal extracts in 1:1 ratio, Group D – Herbal extracts in 1:1 ratio supplemented with sonic agitation, Group E – Herbal extracts in 2:1 ratio, Group F – Herbal extracts in 2:1 ratio supplemented with sonic agitation. Specimens were longitudinally sectioned and evaluated under scanning electron microscope for smear layer removal efficacy. Obtained scores were statistically analyzed using one-way analysis of variance and post-hoc test. Results: Among all, Group B showed the best results followed by Group F. Remaining other groups showed inferior outcome (P < 0.05). Conclusion: The combination of two extracts in 2:1 ratio was slightly better than 1:1 ratio and the smear layer removal efficacy was further improved when accompanied with sonic agitation. PMID:26430300

  12. Qualitative study of patients and health-care professionals' views on the efficacy of the nutrition as medication oral nutrition supplement program.

    PubMed

    Lambert, Kelly; Potter, Jan; Lonergan, Maureen; Tapsell, Linda; Charlton, Karen E

    2017-09-01

    The use of concentrated oral nutrition supplements dispensed in small volumes throughout the day at medication rounds is a common nutrition support strategy. Often termed 'Nutrition as Medication' or NAM, it is associated with excellent rates of patient consumption. However, administration of NAM has been described as suboptimal. The aim of the present study was to identify and explore factors influencing the efficacy of the NAM program from a qualitative perspective. This included exploring issues relating to knowledge, administration and patient consumption from a patient and health professional perspective. Semistructured interviews with patients (n = 7) and eight focus groups with nursing, medical, pharmacy and dietetic staff (n = 63) were conducted. Interviews were conducted in the workplace and were recorded and transcribed verbatim. Data were analysed from a realist theoretical position using the thematic framework approach. Five themes were identified that impact on the efficacy of the NAM program. These include the need for clear role delineation among health professionals regarding responsibility for each aspect of NAM. Other themes that emerged included misconceptions about the importance and relevance of the treatment; perceptions of poor palatability and issues associated with the logistics of providing the supplements within the hospital setting. Dietitians should be aware that there are a range of factors that influence the efficacy of the NAM strategy, including the knowledge and values of individual health professional staff. In addition, increased awareness is required by dietitians regarding the structural barriers to administration and receiving of NAM at the ward level. © 2015 Dietitians Association of Australia.

  13. Anterior segment complications of a nutritional supplement.

    PubMed

    Randhawa, Sandeep; Abowd, Michael; Sharma, Ashish; Weiss, Jayne S

    2007-05-01

    A patient who had been taking an oral L-arginine-based body-building supplement developed bilateral diffuse subconjunctival hemorrhages, circumcorneal dilated vessels, and peripheral corneal infiltrates after bilateral laser in situ keratomileusis. There is limited information regarding the efficacy, safety, and constituents of nutritional supplements because the U.S. Food and Drug Administration regulates them differently than prescription medications, and they do not require approval prior to marketing. These products may result in adverse effects as evidenced by the subconjunctival hemorrhages (an exaggerated vasodilator and antithrombotic effect of nitric oxide formed from arginine) and peripheral corneal infiltrates in this case. The case highlights the importance of eliciting a history of nutritional supplement and/or herbal medication use, especially in patients scheduled to have surgery.

  14. The Effect of Prebiotic Supplementation with Inulin On Cardiometabolic Health: Rationale, Design, and Methods Of A Controlled Feeding Efficacy Trial in Adults at Risk of Type 2 Diabetes

    PubMed Central

    Mitchell, Cassie M.; Davy, Brenda M.; Halliday, Tanya M.; Hulver, Mathew W.; Neilson, Andrew P.; Ponder, Monica A.; Davy, Kevin P.

    2015-01-01

    Prediabetes is associated with low-grade chronic inflammation that increases the risk for developing type 2 diabetes (T2D) and cardiovascular disease (CVD). An elevated lipopolysaccharide concentration, associated with dysbiosis of the intestinal microbiota, has been implicated in the development of both T2D and CVD. Selective modulation of the intestinal microbiota with prebiotics reduces intestinal permeability and endotoxin concentrations, inflammation, and metabolic dysfunction in rodents. The effect of prebiotic supplementation on cardio-metabolic function in those at risk for T2D is not known. The primary aim of this trial is to determine the influence of prebiotic supplementation with inulin on insulin sensitivity and skeletal muscle metabolic flexibility in adults at risk for T2D. We hypothesize that prebiotic supplementation with inulin will improve insulin sensitivity and skeletal muscle metabolic flexibility. We will randomize 48 adults (40–75 yrs) with prediabetes or a score ≥5 on the American Diabetes Association (ADA) risk screener to 6 weeks of prebiotic supplementation with inulin (10 g/day) or placebo. Subjects will be provided with all food for the duration of the study, to avoid potential confounding through differences in dietary intake between individuals. Intestinal permeability, serum endotoxin concentrations, insulin sensitivity, skeletal muscle metabolic flexibility, endothelial function, arterial stiffness, and fecal bacterial composition will be measured at baseline and following treatment. The identification of prebiotic supplementation with inulin as an efficacious strategy for reducing cardio-metabolic risk in individuals at risk of T2M could impact clinical practice by informing dietary recommendations and increasing acceptance of prebiotics by the scientific and medical community. PMID:26520413

  15. The effect of prebiotic supplementation with inulin on cardiometabolic health: Rationale, design, and methods of a controlled feeding efficacy trial in adults at risk of type 2 diabetes.

    PubMed

    Mitchell, Cassie M; Davy, Brenda M; Halliday, Tanya M; Hulver, Mathew W; Neilson, Andrew P; Ponder, Monica A; Davy, Kevin P

    2015-11-01

    Prediabetes is associated with low-grade chronic inflammation that increases the risk for developing type 2 diabetes (T2D) and cardiovascular disease (CVD). An elevated lipopolysaccharide concentration, associated with dysbiosis of the intestinal microbiota, has been implicated in the development of both T2D and CVD. Selective modulation of the intestinal microbiota with prebiotics reduces intestinal permeability and endotoxin concentrations, inflammation, and metabolic dysfunction in rodents. The effect of prebiotic supplementation on cardio-metabolic function in humans at risk for T2D is not known. The primary aim of this trial is to determine the influence of prebiotic supplementation with inulin on insulin sensitivity and skeletal muscle metabolic flexibility in adults at risk for T2D. We hypothesize that prebiotic supplementation with inulin will improve insulin sensitivity and skeletal muscle metabolic flexibility. We will randomize 48 adults (40-75 yrs) with prediabetes or a score ≥ 5 on the American Diabetes Association (ADA) risk screener to 6 weeks of prebiotic supplementation with inulin (10 g/day) or placebo. Subjects will be provided with all food for the duration of the study, to avoid potential confounding through differences in dietary intake between individuals. Intestinal permeability, serum endotoxin concentrations, insulin sensitivity, skeletal muscle metabolic flexibility, endothelial function, arterial stiffness, and fecal bacterial composition will be measured at baseline and following treatment. The identification of prebiotic supplementation with inulin as an efficacious strategy for reducing cardio-metabolic risk in individuals at risk of T2D could impact clinical practice by informing dietary recommendations and increasing acceptance of prebiotics by the scientific and medical community.

  16. International Society of Sports Nutrition position stand: safety and efficacy of creatine supplementation in exercise, sport, and medicine.

    PubMed

    Kreider, Richard B; Kalman, Douglas S; Antonio, Jose; Ziegenfuss, Tim N; Wildman, Robert; Collins, Rick; Candow, Darren G; Kleiner, Susan M; Almada, Anthony L; Lopez, Hector L

    2017-01-01

    Creatine is one of the most popular nutritional ergogenic aids for athletes. Studies have consistently shown that creatine supplementation increases intramuscular creatine concentrations which may help explain the observed improvements in high intensity exercise performance leading to greater training adaptations. In addition to athletic and exercise improvement, research has shown that creatine supplementation may enhance post-exercise recovery, injury prevention, thermoregulation, rehabilitation, and concussion and/or spinal cord neuroprotection. Additionally, a number of clinical applications of creatine supplementation have been studied involving neurodegenerative diseases (e.g., muscular dystrophy, Parkinson's, Huntington's disease), diabetes, osteoarthritis, fibromyalgia, aging, brain and heart ischemia, adolescent depression, and pregnancy. These studies provide a large body of evidence that creatine can not only improve exercise performance, but can play a role in preventing and/or reducing the severity of injury, enhancing rehabilitation from injuries, and helping athletes tolerate heavy training loads. Additionally, researchers have identified a number of potentially beneficial clinical uses of creatine supplementation. These studies show that short and long-term supplementation (up to 30 g/day for 5 years) is safe and well-tolerated in healthy individuals and in a number of patient populations ranging from infants to the elderly. Moreover, significant health benefits may be provided by ensuring habitual low dietary creatine ingestion (e.g., 3 g/day) throughout the lifespan. The purpose of this review is to provide an update to the current literature regarding the role and safety of creatine supplementation in exercise, sport, and medicine and to update the position stand of International Society of Sports Nutrition (ISSN).

  17. Efficacy of nutritional supplementation with omega-3 and omega-6 fatty acids in dry eye syndrome: a systematic review of randomized clinical trials.

    PubMed

    Molina-Leyva, Ignacio; Molina-Leyva, Alejandro; Bueno-Cavanillas, Aurora

    2017-03-30

    To critically appraise scientific evidence regarding the efficacy of nutritional supplementation with omega-3 and omega-6 fatty acids for the treatment of dry eye syndrome (DES). A systematic review of randomized clinical trials was performed. Two independent reviewers selected and analysed the scientific papers that met inclusion and exclusion criteria. Objective and subjective efficacy outcomes were assessed. The trials involved a total of 2591 patients in fifteen independent studies. All studies were published between 2005 and 2015. The supplements used were mostly omega-3 and omega-6 in different proportions. Subjective improvement was measured using mainly Ocular Surface Disease Index (OSDI) test and Dry Eye Severity Score (DESS) test: significant differences in favour of the experimental group were found in seven of the studies. The objective amelioration was assessed by lacrimal function parameters: Tear break-up time (TBUT) significantly increased in nine studies and Schirmer's test in four studies. We observed a discrete improvement in the parameters of tear function. Scientific evidence is not strong enough to systematically recommend the use of omega-3 and omega-6 fatty acids as a standalone treatment of DES independently from its aetiology. However, they could be considered as an effective alternative to topical treatment in patients with DES secondary to certain pathologies. © 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  18. Is Supplementation Efficacious in Maintaining Adequate Plasma Levels of Vitamin A and E for Thalassemic Patients Undergoing Hematopoietic Stem Cell Transplantation? A Cross-Sectional Study

    PubMed Central

    Hajimahmoodi, Mannan; Hadjibabaie, Molouk; Hamidieh, Amir-Ali; Ahmadvand, Alireza; Kazempanah, Sahebeh; Sadeghi, Naficeh; Mansouri, Ava; Ghavamzadeh, Ardeshir

    2014-01-01

    Objective: Thalassemia along with hematopoietic stem cell transplantation (HSCT) can lead to major oxidative stress. Vitamins A and E are antioxidants which protect membrane from lipid peroxidation. We sought to determine for the first time, whether vitamins A and E supplementation is efficacious in maintaining or increasing plasma level of these vitamins in thalassemic children undergoing HSCT. Methods: A cross-sectional study was performed on 50 children with β-thalassemia major hospitalized for HSCT. Patients took a daily multivitamin. Plasma vitamins A and E levels were measured at four different times: on admission, HSCT day (day 0), day 7 and day 14 after HSCT. Findings : Plasma vitamin A and E were abnormal on admission in most patients (62.0% and 60.0% respectively). Ratio of patient with normal to abnormal plasma level of the vitamins improved from baseline to a peak on day 7 then deteriorated afterward until day 14. There was an increasingly positive correlation between daily oral intake and plasma vitamin A at different times, but plasma vitamin E showed inverse correlation at first which tended towards no correlation subsequently. In multivariate analysis, supplementation significantly changed plasma level of vitamin A at different measurement time (P=0.001) within study subjects. But, plasma level of vitamin E showed no significant difference (P=0.2). Conclusion: Our findings suggest that oral supplementation could have beneficial effects due to increasing plasma vitamin A level and preventing plasma vitamin E depletion. PMID:25793043

  19. Effect of Medicinal Plant By-products Supplementation to Total Mixed Ration on Growth Performance, Carcass Characteristics and Economic Efficacy in the Late Fattening Period of Hanwoo Steers

    PubMed Central

    Lee, S. J.; Kim, D. H.; Guan, Le Luo; Ahn, S. K.; Cho, K. W.; Lee, Sung S.

    2015-01-01

    This study was conducted to evaluate the effect of medicinal plant by-products (MPB) supplementation to a total mixed ration (TMR) on growth, carcass characteristics and economic efficacy in the late fattening period of Hanwoo steers. Twenty seven steers (body weight [BW], 573±57 kg) were assigned to 3 treatment groups so that each treatment based on BW contained 9 animals. All groups received ad libitum TMR throughout the feeding trial until slaughter (from 24 to 30 months of age) and treatments were as follows: control, 1,000 g/kg TMR; treatment 1 (T1), 970 g/kg TMR and 30 g/kg MPB; treatment 2 (T2), 950 g/kg TMR and 50 g/kg MPB. Initial and final BW were not different among treatments. Resultant data were analyzed using general linear models of SAS. Average daily gain and feed efficiency were higher (p<0.05) for T1 than control, but there was no difference between control and T2. Plasma albumin showed low-, intermediate- and high-level (p<0.05) for control, T1 and T2, whereas non-esterified fatty acid was high-, intermediate- and high-level (p<0.05) for control, T1 and T2, respectively. Carcass weight, carcass rate, backfat thickness and rib eye muscle area were not affected by MPB supplementation, whereas quality and yield grades were highest (p<0.05) for T1 and T2, respectively. Daily feed costs were decreased by 0.5% and 0.8% and carcass prices were increased by 18.1% and 7.6% for T1 and T2 compared to control, resulting from substituting TMR with 30 and 50 g/kg MPB, respectively. In conclusion, the substituting TMR by 30 g/kg MPB may be a potential feed supplement approach to improve economic efficacy in the late fattening period of Hanwoo steers. PMID:26580440

  20. Basis for regulation of selenium supplements in animal diets.

    PubMed

    Ullrey, D E

    1992-12-01

    Selenium was discovered 174 yr ago but, until 1957, was given little notice by biologists or was vilified as an agent that caused toxicity in grazing ruminants and horses in the northern Great Plains. After its status as an essential nutrient was established, Se received intense scrutiny, and hundreds of papers have been published dealing with its metabolic functions and the consequences of a Se deficiency. Because regions of Se deficiency are so extensive in the United States, great efforts have been made to gain Food and Drug Administration (FDA) approval for Se supplementation of animal diets. Initially, these efforts were thwarted by concern that Se might be carcinogenic. After this concern was resolved, researchers established supplemental Se levels that were efficacious, safe for animals, safe for humans that eat animal products, and protective of the environment. First approval of Se supplements was given in 1974 for supplementation of swine or growing chicken diets at .1 ppm. Supplements for turkey diets were approved at .2 ppm. Ultimately, in 1987, levels of supplemental Se in diets for chickens, turkeys, ducks, swine, sheep, and cattle were approved at .3 ppm. However, FDA regulations do not mention horses or zoo animals, and those who would ensure the welfare of these species by supplementing Se-deficient diets may be in violation of FDA interpretation of the law. In addition, the association of Se with death and deformities in aquatic birds at the Kesterson Reservoir in California has led to pressure on the FDA to reverse the 1987 amendments to the feed additive regulation.(ABSTRACT TRUNCATED AT 250 WORDS)

  1. Efficacy of calcium supplementation for human bone health by mass spectrometry profiling and cathepsin K measurement in plasma samples.

    PubMed

    Zhao, Yingchun; Cao, Rui; Ma, Danjun; Zhang, Hengwei; Lappe, Joan; Recker, Robert R; Xiao, Gary Guishan

    2011-09-01

    Osteoporosis is a common disease among older people, especially postmenopausal women. Calcium supplementation is effective in decreasing the occurrence of osteoporosis. We tested the effect of different calcium sources (i.e., calcium carbonate chew, milk mineral chew, milk drink and placebo chew) by direct mass spectrometry (dMS) profiling and cathepsin K measurement in the serum of subjects. The dMS method is promising for plasma biomarker discovery, and cathepsin K level in the plasma is an indicator for osteoporosis. Our result shows that dMS detected characteristic ion peaks after different calcium supplement interventions; ion peak 4281.0 m/z was commonly inhibited by all three treatments. This ion peak was identified to be a fragment of follistatin-related protein 3 precursor by means of the "Lift" mode of MS/MS. The other differential ion peaks were also successfully identified: 1786.5 m/z (upregulated after calcium carbonate chew) was shown to be one fragment of transcription factor jun-B; the parent protein of 3504.7 m/z (upregulated after milk drink) was a collagen alpha-2 (type I) chain precursor; the ion peak of 3359.6 m/z (downregulated after milk mineral chew) was one fragment of family 31 glucosidase. Cathepsin K is significantly inhibited only by calcium carbonate chew treatment, indicating this form of calcium supplement has some advantage over other sources of supplementation.

  2. Review of the safety and efficacy of vitamin A supplementation in the treatment of children with severe acute malnutrition

    USDA-ARS?s Scientific Manuscript database

    World Health Organization (WHO) guidelines recommend for children with severe acute malnutrition (SAM), high-dose vitamin A (VA) supplements be given on day 1 of admission, and on days 2 and 14 in the case of clinical signs of vitamin A deficiency (VAD). Daily low-dose VA follows, delivered in a pre...

  3. Efficacy of iron and/or zinc supplementation on cognitive performance of lead-exposed Mexican schoolchildren: a randomized, placebo-controlled trial.

    PubMed

    Rico, Javier Alatorre; Kordas, Katarzyna; López, Patricia; Rosado, Jorge L; Vargas, Gonzalo García; Ronquillo, Dolores; Stoltzfus, Rebecca J

    2006-03-01

    Lead exposure in children has been associated with both global and specific cognitive deficits. Although chelation therapy is advised for children with blood lead concentrations of >44 microg/dL, treatment options for children with lower blood lead values are limited. Because lead absorption is related to children's nutritional status, micronutrient supplements may be 1 strategy for combating low-level, chronic lead exposure. This study was designed to test the efficacy of iron and zinc supplementation for lowering blood lead concentrations and improving cognitive performance in schoolchildren who live in a lead-contaminated city. This randomized, double-blind, placebo-controlled field trial was conducted in public elementary schools in Torreón, an industrialized city in northern Mexico. A metal foundry, located close to the city center and within 3.5 km of 9 schools, was the main source of lead exposure. A total of 602 children who were aged 6 to 8 years and regularly attending first grade in the study schools were enrolled. Children were given 30 mg of iron, 30 mg of zinc, both, or a placebo daily for 6 months. A total of 527 completed the treatment, and 515 were available for long-term follow-up, after another 6 months without supplementation. Eleven cognitive tests of memory, attention, visual-spatial abilities, and learning were administered at baseline and each follow-up. There were no consistent or lasting differences in cognitive performance among treatment groups. Daily supplementation with iron and/or zinc may be of limited usefulness for improving cognition in lead-exposed schoolchildren. However, these treatments may be effective in settings with higher prevalence of nutritional deficiencies or in younger children.

  4. An Open-Label Evaluator Blinded Study of the Efficacy and Safety of a New Nutritional Supplement in Androgenetic Alopecia: A Pilot Study

    PubMed Central

    Nichols, Anna J.; Hughes, Olivia Bosshardt; Canazza, Agnese

    2017-01-01

    Objective: To evaluate the effectiveness of a novel oral supplement, Forti5®, containing green tea extract, omega 3 and 6 fatty acids, cholecalciferol, melatonin, beta-sitosterol, and soy isoflavones, and in the management of subjects with androgenetic alopecia. Design: A prospective case series of 10 subjects. Setting: Open-label, evaluator-blinded, proof-of-concept study. Participants: Ten adult subjects with androgenetic alopecia completed the study. Subjects were not allowed to use oral or topical hair growth products in the 24 weeks preceding the study or during the study. The nutritional supplement was administered at a dosage of two tablets daily for 24 weeks. Measurements: Clinical evaluations were performed at baseline and at 24 weeks. Efficacy was evaluated using hair mass index measured by cross section trichometer, terminal hair count measured with dermoscopy and Investigator Global Photography Assessment. Results: Overall 80 percent of subjects (8/10) were rated as improved after 24 weeks of supplementation (mean change of +1.4 equivalent to slightly-to-moderately increased). Forty percent of subjects (4/10) were rated as moderately improved (2+), and 10 percent (1/10) were rated as greatly improved (3+). There was a significant improvement in terminal hair count (mean increase of 5.9% or 4.2 more terminal hairs in the area examined, p=0.014) and in Hair Mass Index (mean increase of 9.5% or 4.5 higher Hair Mass Index, p=0.003). Conclusion: These preliminary results indicate that Forti5® a novel nutritional supplement that contains cholecalciferol, omega 3 and 6 fatty acids, melatonin, antioxidants, and botanical 5-alpha reductase inhibitors, may be a useful adjunct in the treatment of androgenetic alopecia. PMID:28367262

  5. Efficacy and safety of creatine supplementation in childhood-onset systemic lupus erythematosus: a randomized, double-blind, placebo-controlled, crossover trial.

    PubMed

    Hayashi, A P; Solis, M Y; Sapienza, M T; Otaduy, M C G; de Sá Pinto, A L; Silva, C A; Sallum, A M E; Pereira, R M R; Gualano, B

    2014-12-01

    Creatine supplementation has emerged as a promising non-pharmacological therapeutic strategy to counteract muscle dysfunction and low lean mass in a variety of conditions, including in pediatric and rheumatic diseases. The objective of this study was to examine the efficacy and safety of creatine supplementation in childhood systemic lupus erythematosus (C-SLE). C-SLE patients with mild disease activity (n = 15) received placebo or creatine supplementation in a randomized fashion using a crossover, double-blind, repeated-measures design. The participants were assessed at baseline and after 12 weeks in each arm, interspersed by an eight-week washout period. The primary outcomes were muscle function, as assessed by a battery of tests including one-maximum repetition (1-RM) tests, the timed-up-and-go test, the timed-stands test, and the handgrip test. Secondary outcomes included body composition, biochemical markers of bone remodeling, aerobic conditioning, quality of life, and physical capacity. Possible differences in dietary intake were assessed by three 24-hour dietary recalls. Muscle phosphorylcreatine content was measured through phosphorus magnetic resonance spectroscopy (31 P-MRS). The safety of the intervention was assessed by laboratory parameters, and kidney function was measured by (51)Cr-EDTA clearance. Additionally, self-reported adverse events were recorded throughout the trial. Intramuscular phosphorylcreatine content was not significantly different between creatine and placebo before or after the intervention (creatine-Pre: 20.5 ± 2.6, Post: 20.4 ± 4.1, placebo-Pre: 19.8 ± 2.0; Post: 20.2 ± 3.2 mmol/kg wet muscle; p = 0.70 for interaction between conditions). In addition, probably as a consequence of the lack of change in intramuscular phosphorylcreatine content, there were no significant changes between placebo and creatine for any muscle function and aerobic conditioning parameters, lean mass, fat mass, bone mass, and quality of life scores (p

  6. The relationship between maternal self-efficacy, compliance and outcome in a trial of vitamin D supplementation in pregnancy.

    PubMed

    Barker, M; D'Angelo, S; Ntani, G; Lawrence, W; Baird, J; Jarman, M; Vogel, C; Inskip, H; Cooper, C; Harvey, N C

    2017-01-01

    In a randomised controlled trial of vitamin D during pregnancy, we demonstrated that women with lower self-efficacy were more likely to experience practical problems with taking the trial medication and that this was associated with lower compliance and achieved 25(OH)-vitamin D concentrations.

  7. Efficacy of Enteral Supplementation Enriched with Glutamine, Fiber, and Oligosaccharide on Mucosal Injury following Hematopoietic Stem Cell Transplantation

    PubMed Central

    Iyama, Satoshi; Sato, Tsutomu; Tatsumi, Hiroomi; Hashimoto, Akari; Tatekoshi, Ayumi; Kamihara, Yusuke; Horiguchi, Hiroto; Ibata, Soushi; Ono, Kaoru; Murase, Kazuyuki; Takada, Kohichi; Sato, Yasushi; Hayashi, Tsuyoshi; Miyanishi, Koji; Akizuki, Emi; Nobuoka, Takayuki; Mizugichi, Toru; Takimoto, Rishu; Kobune, Masayoshi; Hirata, Koichi; Kato, Junji

    2014-01-01

    The combination of glutamine, fiber and oligosaccharides (GFO) is thought to be beneficial for alleviating gastrointestinal mucosal damage caused by chemotherapy. A commercial enteral supplementation product (GFO) enriched with these 3 components is available in Japan. We performed a retrospective study to test whether oral GFO decreased the severity of mucosal injury following hematopoietic stem cell transplantation (HSCT). Of 44 HSCT patients, 22 received GFO and 22 did not. Severity of diarrhea/mucositis, overall survival, weight loss, febrile illness/documented infection, intravenous hyperalimentation days/hospital days, engraftment, acute and chronic GVHD, and cumulative incidence of relapse were studied. Sex, age, performance status, diagnosis, disease status, and treatment variables were similar in both groups. There were fewer days of diarrhea grade 3–4 in patients receiving GFO than in those who did not (0.86 vs. 3.27 days); the same was true for days of mucositis grade 3–4 (3.86 vs. 6.00 days). Survival at day 100 was 100% in the GFO group, but only 77.3% for the patients not receiving GFO (p = 0.0091, log-rank test). Weight loss and the number of days of intravenous hyperalimentation were better in the GFO group (p < 0.001 and p = 0.0014, respectively). Although not significant, less gut bacterial translocation with Enterococcus species developed in the GFO group (p = 0.0728) than in the non-GFO group. Other outcomes were not affected. To the best of our knowledge, this is the first comparative clinical study of GFO supplementation to alleviate mucosal injury after allo-HSCT. We conclude that glutamine, fiber and oligosaccharide supplementation is an effective supportive therapy to decrease the severity of mucosal damage in HSCT. PMID:25493082

  8. Efficacy of protein, symbiotic and probiotic supplementation on production performance and egg quality characteristics in molted layers.

    PubMed

    Anwar, Haseeb; Rahman, Zia Ur

    2016-10-01

    Two hundred white leg horn layers at 70 weeks of age were induced to molt with high dietary zinc (3 g/kg of feed); thereafter, birds were equally and randomly divided (n = 50 each) into four groups keeping G1 as control (CP 16 % diet, no other supplement), G2 (CP 18 % diet), G3 (CP 16 % diet + symbiotic; Perfectin® at 85 mg/L in drinking water daily), and G4 (CP 16 % diet + probiotic; Protexin® at 85 mg/L in drinking water daily). The egg production record was maintained throughout the experiment period, and egg quality parameters were performed at 5 %, peak, and end of post molt production stage. The overall egg production was highest in G2 (74.51 %) followed by G3 (64.95 %) and G4 (65.03 %) and lowest in G1 (58.51 %). The overall egg weight, length, diameter, weight and diameter of albumin and yolk, egg shell thickness as well as egg shell breaking strength increased (P ≤ 0.01) in G2 and G3 as compared to G1. The albumin height, yolk height, yolk index, and haugh unit score decreased (P ≤ 0.01) in G2 and G3 as compared to G1. FCR/12 eggs improved in all the supplemented groups as compared to control (G1). The bacterial contamination of eggs was seen in G1. Conclusively, it was observed in the current experiment that the supplementation with protein, probiotic, and symbiotic did improve the production quality and potential in molted layers.

  9. Soaking increases the efficacy of supplemental microbial phytase in a low-phosphorus corn-soybean meal diet for growing pigs.

    PubMed

    Liu, J; Bollinger, D W; Ledoux, D R; Ellersieck, M R; Veum, T L

    1997-05-01

    Sixty-three crossbred barrows averaging 18.7 kg initial BW were used in a 6-wk study of the effects of soaking on the efficacy of supplemental microbial phytase (Natuphos, BASF) in a low-P corn-soybean meal diet. The basal corn-soybean meal diet contained .06% available P, .32% total P, and .55% Ca with no added inorganic P. The basal diet was supplemented with 0, 250, or 500 phytase units (PU)/kg of diet. The diet was fed dry or soaked (2 parts water:1 part diet and mixed for 2 h at 30 degrees C before feeding) in a 3 x 2 factorial arrangement. A positive control diet was supplemented with inorganic P and provided .23% available P, .48% total P, and .60% Ca. Pigs were individually penned and fed their respective diets to appetite in four equal meals daily. There were no soaking x phytase interactions (P > .1 to .6) for growth performance criteria. Daily gain and gain/feed ratio were increased (P < .01) by soaking and increased linearly (P < .01) by phytase. Daily feed intake was increased linearly (P < .01) by phytase. There were soaking x phytase quadratic interactions (P < .01) for apparent P absorption criteria because soaking the 250 PU/kg diet increased P absorption similar to that obtained with the 500 PU/kg diet fed dry. Apparent P absorption criteria were increased by soaking (P < .01) and were increased linearly (P < .001) and quadratically (P < .03) by phytase. Phytase reduced fecal P excretion 37 to 40% with dry feeding (P < .03) and 48 to 49% with soaking (P < .01).

  10. Safety and Efficacy of High-dose Daily Vitamin D3 Supplementation in Children and Young Adults With Sickle Cell Disease.

    PubMed

    Dougherty, Kelly A; Bertolaso, Chiara; Schall, Joan I; Smith-Whitley, Kim; Stallings, Virginia A

    2015-07-01

    Suboptimal vitamin D (vit D) status (<32 ng/mL) is ubiquitous among African American children with type SS sickle cell disease (SCD-SS). The vit D supplemental dose to normalize vit D status is unknown. Five to 20-year-old African American children with (n=21) and without (n=23) SCD-SS were randomized to vit D3 supplementation (4000 or 7000 IU/d) and evaluated at 6 and 12 weeks for changes in vit D and SCD status. A dose was considered unsafe if serum calcium was elevated associated with elevated serum 25 hydroxyvitamin D (25(OH)D). At baseline 95% of subjects with SCD-SS and 87% of healthy controls had suboptimal vit D status (mean±SD, 19.2±7.2 and 22.3±9.3 ng/mL, respectively). After 12 weeks supplementation, both D3 doses were safe and well tolerated. Neither group achieved the a priori efficacy criterion of 25(OH)D≥32 ng/mL in >80% of subjects (45% in SCD-SS and 63% in controls). However, for both subjects with SCD-SS and healthy subjects by 12 weeks, deficient (<20 ng/mL) vit D status was eliminated only in those receiving 7000 IU/d. For subjects with SCD-SS, by 12 weeks there was a significant (all P<0.05) increase in fetal hemoglobin, decrease in high-sensitivity C-reactive protein, and reduction in the percentage of subjects with a high platelet count.

  11. Efficacy and tolerability of an undenatured type II collagen supplement in modulating knee osteoarthritis symptoms: a multicenter randomized, double-blind, placebo-controlled study.

    PubMed

    Lugo, James P; Saiyed, Zainulabedin M; Lane, Nancy E

    2016-01-29

    Undenatured type II collagen (UC-II) is a nutritional supplement derived from chicken sternum cartilage. The purpose of this study was to evaluate the efficacy and tolerability of UC-II for knee osteoarthritis (OA) pain and associated symptoms compared to placebo and to glucosamine hydrochloride plus chondroitin sulfate (GC). One hundred ninety one volunteers were randomized into three groups receiving a daily dose of UC-II (40 mg), GC (1500 mg G & 1200 mg C), or placebo for a 180-day period. The primary endpoint was the change in total Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) from baseline through day 180 for the UC-II group versus placebo and GC. Secondary endpoints included the Lequesne Functional Index (LFI), the Visual Analog Scale (VAS) for pain and the WOMAC subscales. Modified intent-to-treat analysis were performed for all endpoints using analysis of covariance and mixed model repeated measures, while incremental area under the curve was calculated by the intent-to-treat method. At day 180, the UC-II group demonstrated a significant reduction in overall WOMAC score compared to placebo (p = 0.002) and GC (p = 0.04). Supplementation with UC-II also resulted in significant changes for all three WOMAC subscales: pain (p = 0.0003 vs. placebo; p = 0.016 vs. GC); stiffness (p = 0.004 vs. placebo; p = 0.044 vs. GC); physical function (p = 0.007 vs. placebo). Safety outcomes did not differ among the groups. UC-II improved knee joint symptoms in knee OA subjects and was well-tolerated. Additional studies that elucidate the mechanism for this supplement's actions are warranted. CTRI/2013/05/003663 ; CTRI/2013/02/003348 .

  12. A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation

    PubMed Central

    Manfrini, Enrico; Ferri, Emanuele; La Ferla, Barbara; Schiano, Irene; Michelotti, Angela; Nobile, Vincenzo

    2016-01-01

    Background and Aim. The efficacy of supplementation treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C and the assessment of their gut microbiota were investigated. Methods. A randomized, double-blind, three-arm parallel group trial was carried out on 150 IBS-C subjects divided into three groups (F_1, F_2, and F_3). Each group received a daily oral administration of probiotic mixtures (for 60 days) F_1 or F_2 or placebo F_3, respectively. Fecal microbiological analyses were performed by species-specific qPCR to assess the different amount of probiotics. Results. The percentage of responders for each symptom was higher in the probiotic groups when compared to placebo group during the treatment period (t60) and was maintained quite similar during the follow-up period (t90). Fecal analysis demonstrated that probiotics of the formulations increased during the times of treatment only in fecal DNA from subjects treated with F_1 and F_2 and not with F_3, and the same level was maintained during the follow-up period. Conclusions. Multispecies probiotic supplementations are effective in IBS-C subjects and induce a different assessment in the composition of intestinal microbiota. This clinical study is registered with the clinical study registration number ISRCTN15032219. PMID:27595104

  13. Efficacy of Folic Acid Supplementation in Autistic Children Participating in Structured Teaching: An Open-Label Trial

    PubMed Central

    Sun, Caihong; Zou, Mingyang; Zhao, Dong; Xia, Wei; Wu, Lijie

    2016-01-01

    Autism spectrum disorders (ASD) are recognized as a major public health issue. Here, we evaluated the effects of folic acid intervention on methylation cycles and oxidative stress in autistic children enrolled in structured teaching. Sixty-six autistic children enrolled in this open-label trial and participated in three months of structured teaching. Forty-four children were treated with 400 μg folic acid (two times/daily) for a period of three months during their structured teaching (intervention group), while the remaining 22 children were not given any supplement for the duration of the study (control group). The Autism Treatment Evaluation Checklist (ATEC) and Psychoeducational Profile-third edition (PEP-3) were measured at the beginning and end of the treatment period. Folic acid, homocysteine, and glutathione metabolism in plasma were measured before and after treatment in 29 autistic children randomly selected from the intervention group and were compared with 29 age-matched unaffected children (typical developmental group). The results illustrated folic acid intervention improved autism symptoms towards sociability, cognitive verbal/preverbal, receptive language, and affective expression and communication. Furthermore, this treatment also improved the concentrations of folic acid, homocysteine, and normalized glutathione redox metabolism. Folic acid supplementation may have a certain role in the treatment of children with autism. PMID:27338456

  14. Efficacy of Folic Acid Supplementation in Autistic Children Participating in Structured Teaching: An Open-Label Trial.

    PubMed

    Sun, Caihong; Zou, Mingyang; Zhao, Dong; Xia, Wei; Wu, Lijie

    2016-06-07

    Autism spectrum disorders (ASD) are recognized as a major public health issue. Here, we evaluated the effects of folic acid intervention on methylation cycles and oxidative stress in autistic children enrolled in structured teaching. Sixty-six autistic children enrolled in this open-label trial and participated in three months of structured teaching. Forty-four children were treated with 400 μg folic acid (two times/daily) for a period of three months during their structured teaching (intervention group), while the remaining 22 children were not given any supplement for the duration of the study (control group). The Autism Treatment Evaluation Checklist (ATEC) and Psychoeducational Profile-third edition (PEP-3) were measured at the beginning and end of the treatment period. Folic acid, homocysteine, and glutathione metabolism in plasma were measured before and after treatment in 29 autistic children randomly selected from the intervention group and were compared with 29 age-matched unaffected children (typical developmental group). The results illustrated folic acid intervention improved autism symptoms towards sociability, cognitive verbal/preverbal, receptive language, and affective expression and communication. Furthermore, this treatment also improved the concentrations of folic acid, homocysteine, and normalized glutathione redox metabolism. Folic acid supplementation may have a certain role in the treatment of children with autism.

  15. P30 Cancer Center Support Grant Administrative Supplements to support NCI Approved Clinical Trial Proposals from NCI-designated Cancer Centers not affiliated with the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) for Investigator-Initiated Trials Utilizing CTEP IND agents in the ETCTN

    Cancer.gov

    P30 Cancer Center Support Grant Administrative Supplements to support NCI Approved Clinical Trial Proposals from NCI-designated Cancer Centers not affiliated with the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) for Investigator-Initiated Trials Utilizing CTEP IND agents in the ETCTN

  16. The efficacy and safety of multivitamin and mineral supplement use to prevent cancer and chronic disease in adults: a systematic review for a National Institutes of Health state-of-the-science conference.

    PubMed

    Huang, Han-Yao; Caballero, Benjamin; Chang, Stephanie; Alberg, Anthony J; Semba, Richard D; Schneyer, Christine R; Wilson, Renee F; Cheng, Ting-Yuan; Vassy, Jason; Prokopowicz, Gregory; Barnes, George J; Bass, Eric B

    2006-09-05

    Multivitamin and mineral supplements are the most commonly used dietary supplements in the United States. To synthesize studies on the efficacy and safety of multivitamin/mineral supplement use in primary prevention of cancer and chronic disease in the general population. English-language literature search of the MEDLINE, EMBASE, and Cochrane databases through February 2006 and hand-searching of pertinent journals and articles. Randomized, controlled trials in adults were reviewed to assess efficacy, and randomized, controlled trials and observational studies in adults or children were reviewed to assess safety. Paired reviewers extracted data and independently assessed study quality. 12 articles from 5 randomized, controlled trials that assessed efficacy and 8 articles from 4 randomized, controlled trials and 3 case reports on adverse effects were identified. Study quality was rated fair for the studies on cancer, cardiovascular disease, cataracts, or age-related macular degeneration and poor for the studies on hypertension. In a poorly nourished Chinese population, combined supplementation with beta-carotene, alpha-tocopherol, and selenium reduced the incidence of and mortality rate from gastric cancer and the overall mortality rate from cancer by 13% to 21%. In a French trial, combined supplementation with vitamin C, vitamin E, beta-carotene, selenium, and zinc reduced the rate of cancer by 31% in men but not in women. Multivitamin and mineral supplements had no significant effect on cardiovascular disease or cataracts, except that combined beta-carotene, selenium, alpha-tocopherol, retinol, and zinc supplementation reduced the mortality rate from stroke by 29% in the Linxian study and that a combination of 7 vitamins and minerals stabilized visual acuity loss in a small trial. Combined zinc and antioxidants slowed the progression of advanced age-related macular degeneration in high-risk persons. No consistent adverse effects of multivitamin and mineral

  17. Efficacy and safety of two doses of pemetrexed supplemented with folic acid and vitamin B12 in previously treated patients with non-small cell lung cancer.

    PubMed

    Ohe, Yuichiro; Ichinose, Yukito; Nakagawa, Kazuhiko; Tamura, Tomohide; Kubota, Kaoru; Yamamoto, Nobuyuki; Adachi, Susumu; Nambu, Yoshihiro; Fujimoto, Toshio; Nishiwaki, Yutaka; Saijo, Nagahiro; Fukuoka, Masahiro

    2008-07-01

    The objective of this study was to evaluate the efficacy and safety of two doses of pemetrexed supplemented with folic acid and vitamin B(12) in pretreated Japanese patients with advanced non-small cell lung cancer (NSCLC). Patients with an Eastern Cooperative Oncology Group performance status 0 to 2, stage III or IV, and who received previously one or two chemotherapy regimens were randomized to receive 500 mg/m(2) pemetrexed (P500) or 1,000 mg/m(2) pemetrexed (P1000) on day 1 every 3 weeks. The primary endpoint was response rate. Of the 216 patients evaluable for efficacy (108 in each arm), response rates were 18.5% (90% confidence interval, 12.6-25.8%) and 14.8% (90% confidence interval, 9.5-21.6%), median survival times were 16.0 and 12.6 months, 1-year survival rates were 59.2% and 53.7%, and median progression-free survival were 3.0 and 2.5 months for the P500 and P1000, respectively. Cox multiple regression analysis indicated that pemetrexed dose was not a significant prognostic factor. Drug-related toxicity was generally tolerable for both doses; however, the safety profile of P500 showed generally milder toxicity. Main adverse drug reactions of severity grade 3 or 4 were neutrophil count decreased (20.2%) and alanine aminotransferase (glutamine pyruvic transaminase) increased (15.8%) in P500 and neutrophil count decreased (24.3%), WBC count decreased (20.7%), and lymphocyte count decreased (18.0%) in P1000. One drug-related death from interstitial lung disease occurred in the P500. P500 and P1000 are similarly active with promising efficacy and acceptable safety outcomes in pretreated patients with NSCLC. These results support the use of P500 as a second- and third-line treatment of NSCLC.

  18. Preliminary Assessment of the Efficacy of Supplementing Knee Extension Capability in a Lower Limb Exoskeleton with FES

    PubMed Central

    Quintero, Hugo A.; Farris, Ryan J.; Ha, Kevin; Goldfarb, Michael

    2013-01-01

    The authors describe a cooperative controller that combines the knee joint actuation of an externally powered lower limb exoskeleton with the torque and power contribution from the electrically stimulated quadriceps muscle group. The efficacy of combining these efforts is experimentally validated with a series of weighted leg lift maneuvers. Measurements from these experiments indicate that the control approach effectively combines the respective efforts of the motor and muscle, such that good control performance is achieved, with substantial torque and energy contributions from both the biological and non-biological actuators. PMID:23366646

  19. Efficacy of growth hormone supplementation with gonadotrophins in vitro fertilization for poor ovarian responders: an updated meta-analysis

    PubMed Central

    Yu, Xiaoying; Ruan, Jian; He, Lian-Ping; Hu, Weihua; Xu, Qinyang; Tang, Jingwen; Jiang, Jian; Han, Jun; Peng, Yi-Feng

    2015-01-01

    Growth hormone (GH) is involved in the regulation of male and female infertility. Several clinical studies reveal that adjuvant GH treatment has a possible role in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), especially in poor ovarian responders (POR) undergoing IVF/ICSI. Recent studies suggest that GH addition in POR patients significantly improves the rate of clinical pregnancy and live birth. Databases including PubMed, Embase, the Cochrane Central China National Knowledge Infrastructure (CNKI) and Google Scholar were searched for randomized controlled trials (RCTs) or controlled clinical trials (CCTs) on the effectiveness of GH supplementation with gonadotrophins in IVF/ICSI for POR. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed methodological quality. Meta Analyst Beta 3.13 software was used to meta-analysis. Eleven studies (six RCTs and five CCTs) and 3788 subjects (613 subjects in cases group and 3175 subjects in controls group) were included in our study. The results of meta-analysis showed that GH addition significantly increased serum E2 level on the day of HCG (OR = 0.55; 95% CI = 0.127-0.973) and MII oocyte number (OR = 0.827; 95% CI = 0.470-1.184). Furthermore, GH addition significantly improved the number of 2PN (OR = 0.934; 95% CI = 0.206-1.661) and obtained embryos (OR = 0.934; 95% CI = 0.206-1.661). However, no significant difference was found for the overall implantation rate was 8.8% (95% CI = -0.062-0.237) and clinical pregnancy rate was 5.1% (95% CI = -0.033-0.134). The present result revel that GH supplementation for IVF/ICSI in POR increases the probability of serum E2 level on the day of HCG, the number of MII oocyte, 2PN and obtained embryos. However, GH addition does not increase implantation rate and clinical pregnancy rates. Due to the limited quantity and quality of the included studies as well as the difference in methodology, we

  20. 29 CFR 1952.227 - Changes to approved plans.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Tennessee § 1952.227 Changes to approved plans. (a) Legislation. (1) On March 29, 1994, the Assistant Secretary approved Tennessee's revised..., the Assistant Secretary approved Tennessee's plan supplement, which is generally identical to the...

  1. 5 CFR 7601.102 - Prior approval of outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ARCHIVES AND RECORDS ADMINISTRATION... obtained from the NARA designated agency ethics official. (b) Standard of approval. Approval shall be... in the activities of a nonprofit charitable, religious, professional, social, fraternal,...

  2. Effect of dietary supplementation with Echinacea purpurea on vaccine efficacy against infection with Flavobacterium columnare in zebrafish (Danio rerio).

    PubMed

    Guz, L; Puk, K; Walczak, N; Oniszczuk, T; Oniszczuk, A

    2014-01-01

    The effect of dietary Echinacea purpurea (EP) on the response of zebrafish (Danio rerio) to a Flavobacterium columnare vaccine was investigated. Two hundred D. rerio with an average weight of 290 ± 40 g were selected and fed different levels of E. purpurea (5 g kg(-1) diet--group 1, 10 g kg(-1) diet--group 2, 20 g kg(-1) diet--group 3, 30 g kg(-1) diet--group 4, and 0 g kg(-1) diet--group 5). Experimental feeding was begun 3 weeks prior to bath immunization and continued until the end of the experiment. Twenty-eight days after immunization the fish were challenged by bath immersion with F. columnare at a concentration of 1 x 10(6) CFU/ml. The relative percent survival of the experimental groups (1, 2, 3, 4 and 5) was 5.0, 6.0, 30.0, 36.0 and 5.0, respectively. In conclusion, diet supplementation with E. purpurea may effectively enhance the response of zebrafish to a F. columnare vaccine.

  3. Efficacy of zinc sulfate supplement on febrile seizure recurrence prevention in children with normal serum zinc level: A randomised clinical trial.

    PubMed

    Fallah, Razieh; Sabbaghzadegan, Saeideh; Karbasi, Sedighah Akhavan; Binesh, Fariba

    2015-01-01

    Serum zinc level might be related to pathogenesis of febrile seizure (FS). The purpose of this study was to evaluate efficacy and safety of oral zinc supplementation on FS recurrence prevention in non-zinc-deficient children. In a randomized clinical study, one hundred 18 to 60 mo old children with normal zinc level with first simple FS were referred to Shahid Sadoughi Hospital, Yazd, Iran from May 2012 to June 2013, were randomly assigned to two groups to receive 2 mg/kg/d zinc sulfate for six consecutive months or placebo as control group and were followed up for 1 y for FS recurrence. 41 girls and 59 boys with mean age of 2.47 ± 1.01 y were evaluated. Race, mean weight, height and body fat were similar in both groups. FS recurrence occurred in 19 children (38%) in the control group [95% confidence interval (CI): 19.45%-53.95%] and in 11 children (22%) in the zinc sulfate (95% CI: 57.47%-89.13%) groups, respectively; and the zinc group had lower FS recurrence (P = 0.03). The mean serum zinc level before intervention was lower in children with FS recurrence (72.43 ± 14.58 μg/dL versus 96.33 ± 12.69 μg/dL, P = 0.04). Gastrointestinal side effects (vomiting in five children, heartburn in two children and abdominal pain in one child) were seen in 16% of the zinc group and vomiting occurred in two children (4%) in control group and frequency of adverse events was similar in the two groups (P = 0.1). Zinc supplementation should be considered as effective and safe in prevention of FS recurrence. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Vitamin D status in autism spectrum disorders and the efficacy of vitamin D supplementation in autistic children.

    PubMed

    Saad, Khaled; Abdel-Rahman, Ahmed A; Elserogy, Yasser M; Al-Atram, Abdulrahman A; Cannell, John J; Bjørklund, Geir; Abdel-Reheim, Mohamed K; Othman, Hisham A K; El-Houfey, Amira A; Abd El-Aziz, Nafisa H R; Abd El-Baseer, Khaled A; Ahmed, Ahmed E; Ali, Ahmed M

    2016-10-01

    Autism spectrum disorder (ASD) is a developmental disorder characterized by pervasive deficits in social interaction, impairment in verbal and non-verbal communication, and stereotyped patterns of interests and activities. Vitamin-D deficiency was previously reported in autistic children. However, the data on the relationship between vitamin D deficiency and the severity of autism are limited. We performed a case-controlled cross-sectional analysis conducted on 122 ASD children, to assess their vitamin D status compared to controls and the relationship between vitamin D deficiency and the severity of autism. We also conducted an open trial of vitamin D supplementation in ASD children. Fifty-seven percent of the patients in the present study had vitamin D deficiency, and 30% had vitamin D insufficiency. The mean 25-OHD levels in patients with severe autism were significantly lower than those in patients with mild/moderate autism. Serum 25-OHD levels had significant negative correlations with Childhood Autism Rating Scale (CARS) scores. Of the ASD group, 106 patients with low-serum 25-OHD levels (<30 ng/ml) participated in the open label trial. They received vitamin D3 (300 IU/kg/day not to exceed 5000 IU/day) for 3 months. Eighty-three subjects completed 3 months of daily vitamin D treatment. Collectively, 80.72% (67/83) of subjects who received vitamin D3 treatment had significantly improved outcome, which was mainly in the sections of the CARS and aberrant behavior checklist subscales that measure behavior, stereotypy, eye contact, and attention span. Vitamin D is inexpensive, readily available and safe. It may have beneficial effects in ASD subjects, especially when the final serum level is more than 40 ng/ml. UMIN-CTR Study Design: trial Number: R000016846.

  5. Consumers' perceptions of the dietary supplement health and education act: implications and recommendations.

    PubMed

    Dodge, Tonya

    2016-01-01

    In 1994, the United States Congress passed the Dietary Supplement Health and Education Act (DSHEA). The regulatory framework for dietary supplements created by DSHEA has led to significant misperceptions regarding consumers' understanding of the safety and efficacy of supplements. Research shows that consumers erroneously believe that: (1) supplements are approved by the government, (2) supplements have been tested for safety and effectiveness, (3) the content of supplements is analyzed, and (4) manufacturers are required to disclose known adverse effects to consumers. Furthermore, labelling requirements that are intended to provide transparency to consumers are relatively ineffective. The following four recommendations are offered for reforming DSHEA: (1) only allow structure-function claims that are supported by research evidence, (2) require manufacturers to list known adverse effects on the labels of dietary supplements, (3) require that the Food and Drug Administration analyzes the content of dietary supplements and (4) restrict the definition of dietary ingredients. These recommendations would bring DSHEA to more closely align with consumer expectations regarding the regulation of dietary supplements and would likely provide a safer landscape for the use of supplements. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  6. Stocking characteristics and perceived increases in sales among small food store managers/owners associated with the introduction of new food products approved by the Special Supplemental Nutrition Program for Women, Infants, and Children.

    PubMed

    Ayala, Guadalupe X; Laska, Melissa N; Zenk, Shannon N; Tester, June; Rose, Donald; Odoms-Young, Angela; McCoy, Tara; Gittelsohn, Joel; Foster, Gary D; Andreyeva, Tatiana

    2012-09-01

    The present study assessed the impact of the 2009 food packages mandated by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) on perceived sales, product selection and stocking habits of small, WIC-authorized food stores. A cross-sectional study involving in-depth interviews with store managers/owners. Small, WIC-authorized food stores in eight major cities in the USA. Fifty-two store managers/owners who had at least 1 year of experience in the store prior to study participation. The WIC-approved food products (fresh, canned and frozen fruits; fresh, canned and frozen vegetables; wholegrain/whole-wheat bread; white corn/whole-wheat tortillas; brown rice; lower-fat milk (<2 %)) were acquired in multiple ways, although acquisition generally occurred 1-2 times/week. Factors such as customer requests (87 %), refrigerator/freezer availability (65 %) and profitability (71 %) were rated as very important when making stocking decisions. Most managers/owners perceived increases in sales of new WIC-approved foods including those considered most profitable (wholegrain/whole-wheat bread (89 %), lower-fat milk (89 %), white corn/whole wheat tortillas (54 %)), but perceived no changes in sales of processed fruits and vegetables. Supply mechanisms and frequency of supply acquisition were only moderately associated with perceived sales increases. Regardless of type or frequency of supply acquisition, perceived increases in sales provided some evidence for the potential sustainability of these WIC policy efforts and translation of this policy-based strategy to other health promotion efforts aimed at improving healthy food access in underserved communities.

  7. A review of radiation countermeasures focusing on injury-specific medicinals and regulatory approval status: part II. Countermeasures for limited indications, internalized radionuclides, emesis, late effects, and agents demonstrating efficacy in large animals with or without FDA IND status.

    PubMed

    Singh, Vijay K; Garcia, Melissa; Seed, Thomas M

    2017-09-01

    The threat of a radiological/nuclear event is a critical concern for all government agencies involved in national security and public health preparedness. Countermeasures that are safe, easily administered, and effective at diminishing or eliminating adverse health effects to individuals and the overall public health impact of radiation exposure are urgently needed. Radiation countermeasures included in this three-part series have been classified under various subheadings based specifically on their developmental stages for United States Food and Drug Administration (FDA) approval. We have included FDA-approved agents for acute radiation syndrome (ARS) in part I. This is part II in which we have reviewed FDA-approved agents for limited indications, internalized radionuclides, emesis, late effects, radiomitigators available in the strategic national stockpile (SNS), agents with FDA investigational new drug (IND) status, and those with NHP efficacy data without FDA IND. Agents discussed in part III are those agents that have been peer reviewed, published, and have demonstrated significant survival benefits in animal models of ARS. Agents investigated in in vitro models only or studied in animal models without peer-reviewed publications have not been included. The dearth of FDA-approved radiation countermeasures has prompted intensified research for a new generation of radiation countermeasures. A number of promising radiation countermeasures are currently moving forward with continued support and effort by both governmental agencies and by publicly and privately held pharmaceutical companies. There is a limited number of countermeasures which are progressing well following the Animal Rule and may get approved in the near future, thus serving to close the gap of this critically important, unmet radiobiomedical need.

  8. Efficacy of an Exercise and Nutritional Supplement Program on Physical Performance and Nutritional Status in Older Adults With Mobility Limitations Residing at Senior Living Facilities.

    PubMed

    Corcoran, Michael P; Nelson, Miriam E; Sacheck, Jennifer M; Reid, Kieran F; Kirn, Dylan; Fielding, Roger A; Chui, Kenneth K H; Folta, Sara C

    2017-01-17

    This cluster-randomized trial was designed to determine the efficacy of a 6-month exercise-nutritional supplement program (ENP) on physical function and nutritional status for older adults and the feasibility of implementing this program in a senior living setting. Twenty senior living facilities were randomized to either a three day per week group-based ENP led by a trained facility staff member or a health education program (SAP). Participants (N=121) completed a short physical performance battery, 400 meter walk, handgrip strength test, and mini-nutrition assessment. 25-hydroxyvitamin D [25(OH)D], Insulin-like growth-factor 1 (IGF-1) and activity level were also measured. The ENP did not significantly improve physical function or nutritional status compared with the SAP. Compared with baseline, participants in the ENP engaged in 39 minutes less physical activity per week at 6-months. Several facility characteristics hindered implementation of the ENP. This study highlights the complexity of implementing an evidence-based program in a field setting.

  9. [Efficacy observation of treating early and midterm chronic renal failure patients by qi supplementing, collateral dredging, detoxifying, and turbidity descending recipe combined with basic methods of Western medicine].

    PubMed

    Guo, Li-fang; Wang, Feng-li; Wang, Yue-hua

    2012-08-01

    To observe therapeutic efficacy of treating early and midterm chronic renal failure (CRF) patients by qi supplementing, collateral dredging, detoxifying, and turbidity descending recipe (QSCDDTDR) combined with basic methods of Western medicine (WM). Totally 160 early and midterm CRF patients were recruited from Hebei Hospital of Traditional Chinese Medicine, Hebei Medical University from January 2007 to December 2011. They were randomly assigned to the treatment group and the control group, 80 in each group. On the basis of basic treatment of WM, QSCDDTDR was given to patients in the treatment group, while niaoduqing granule (NDQG) was given to those in the control group. After 12 months of treatment, the therapeutic efficacy, Chinese medicine (CM) symptom scores, serum creatinine (SCr), blood urine nitrogen (BUN), 24 h urine protein quantitation, hemoglobin (Hb), and the occurrence of end-point events were observed. The total effective rate in the treatment group was 77.6% (28/76), obviously higher than that in the control group [(58.1%, 43/74), P < 0.05]. After treatment the CM syndrome scores obviously decreased in the treatment group (18.3 +/- 5.3), obviously lower than before treatment (26.0 +/- 4.4) and the control group (22.4 +/- 4.9) (P < 0.05, P < 0.01). The levels of SCr, BUN, and 24 h urine protein quantitation were (169.1 +/- 22.6) micromol/L, (10.4 +/- 2.0) mmol/L, (861.4 +/- 232.7) mg/24 h, respectively, in the treatment group after treatment, which were lower than before treatment [(204.1 +/- 27.7) micromol/L, (13.2 +/- 3.2) mmol/L, (1 287.5 +/- 442.3) mg/24 h, P < 0.01). The aforesaid indices were also improved in the control group after treatment (P < 0.05, P < 0.01). The decrease in SCr, BUN, and 24 h urine protein quantitation after treatment was more obviously in the treatment group than in the control group [(185.8 +/- 23.9) micromol/L, (11.2 +/- 2.5) mmol/L, (1014.5 +/- 301.7) mg/24 h; P < 0.05, P < 0.01). The incidence rate of the end

  10. Knowledge of dietary supplement label information among female supplement users.

    PubMed

    Miller, Carla K; Russell, Teri

    2004-03-01

    The use of dietary supplements is a popular form of health behavior, especially among women. Little research has been conducted to determine consumers' comprehension of supplement label information. Therefore, this research evaluated comprehension of supplement label information among women 25-45 years of age who consumed a dietary supplement > or =4 times per week. Participants (n=51) completed a written questionnaire about supplement practices, a 10-item knowledge test, and an individual interview about terms used on supplement labels. Participants answered 70% of the questions correctly on the knowledge test indicating adequate knowledge of dietary sources of nutrients. Knowledge of recommended dosages, dosing instructions, and instructions about inappropriate use of supplements for certain people also was adequate. However, misconceptions regarding the term "natural" on supplement labels, product claims, and testing for product safety existed among participants. Supplement users need additional education about supplement claims and testing for product safety and efficacy to make informed health care choices.

  11. Omega-3 Fatty Acid Formulations in Cardiovascular Disease: Dietary Supplements are Not Substitutes for Prescription Products.

    PubMed

    Fialkow, Jonathan

    2016-08-01

    Omega-3 fatty acid products are available as prescription formulations (icosapent ethyl, omega-3-acid ethyl esters, omega-3-acid ethyl esters A, omega-3-carboxylic acids) and dietary supplements (predominantly fish oils). Most dietary supplements and all but one prescription formulation contain mixtures of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Products containing both EPA and DHA may raise low-density lipoprotein cholesterol (LDL-C). In clinical trials, the EPA-only prescription product, icosapent ethyl, did not raise LDL-C compared with placebo. To correct a common misconception, it is important to note that omega-3 fatty acid dietary supplements are not US FDA-approved over-the-counter drugs and are not required to demonstrate safety and efficacy prior to marketing. Conversely, prescription products are supported by extensive clinical safety and efficacy investigations required for FDA approval and have active and ongoing safety monitoring programs. While omega-3 fatty acid dietary supplements may have a place in the supplementation of diet, they generally contain lower levels of EPA and DHA than prescription products and are not approved or intended to treat disease. Perhaps due to the lack of regulation of dietary supplements, EPA and DHA levels may vary widely within and between brands, and products may also contain unwanted cholesterol or fats or potentially harmful components, including toxins and oxidized fatty acids. Accordingly, omega-3 fatty acid dietary supplements should not be substituted for prescription products. Similarly, prescription products containing DHA and EPA should not be substituted for the EPA-only prescription product, as DHA may raise LDL-C and thereby complicate the management of patients with dyslipidemia.

  12. Pomalidomide: first global approval.

    PubMed

    Elkinson, Shelley; McCormack, Paul L

    2013-05-01

    Pomalidomide (Pomalyst(®)) is a small molecule analogue of thalidomide under development with Celgene Corporation for the oral treatment of haematological and connective tissue diseases. Pomalidomide has been approved in the USA and is awaiting approval in the EU for use with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma that has progressed following at least two prior therapies, including lenalidomide and bortezomib. The efficacy and safety of pomalidomide as monotherapy in patients with relapsed and refractory multiple myeloma has also been evaluated in a phase III trial. The agent is in phase III clinical development for the treatment of myelofibrosis and in phase II development for systemic sclerosis. Pomalidomide is also being investigated in patients with amyloidosis, prostate cancer, small cell lung cancer, pancreatic cancer, graft-versus-host disease, and Waldenstrom's macroglobulinaemia. This article summarizes the milestones in the development of pomalidomide leading to this first global approval for relapsed and refractory multiple myeloma.

  13. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. Link to... or effectiveness of the device for which the applicant has an approved PMA, unless the change is of...

  14. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. Link to... or effectiveness of the device for which the applicant has an approved PMA, unless the change is of...

  15. Prevalence of 25-OH vitamin D deficiency in a population of hemodialysis patients and efficacy of an oral ergocalciferol supplementation regimen.

    PubMed

    Porter, Anna; Gilmartin, Cheryl; Srisakul, Usasiri; Arruda, Jose; Akkina, Sanjeev

    2013-01-01

    Optimal dosing regimens for 25-OH vitamin D (VitD) deficiency are unknown in hemodialysis (HD) patients. Our aim was to evaluate the efficacy of prescribing ergocalciferol supplementation based on KDOQI guidelines for chronic kidney disease (CKD) stages III-IV in HD patients. We conducted a retrospective study of 96 urban, predominately African-American HD patients at a single-center dialysis unit with VitD insufficiency or deficiency treated with ergocalciferol. Patients were classified as either compliant or non-compliant with supplementation as determined by review of pharmacy records. The primary outcome was VitD levels 6 months after initiation of treatment and secondary outcomes were VitD levels at 11 months, bone/mineral and anemia parameters. The population was predominately African-American (69%) and Hispanic (28%). There were 61 individuals in the compliant group and 35 individuals in the non-compliant group. The compliant group was older but otherwise similar in demographics and co-morbid conditions to the non-compliant group. After 6 months of treatment, the compliant group had a significant increase in VitD level (14.7 ± 6.0 to 28.7 ± 10.0 ng/ml, p < 0.0001) compared to the non-compliant group (14.7 ± 5.5 to 14.8 ± 7.1 ng/ml, p = 0.95). There were no differences in the incidence of hypercalcemia between the two groups. Except for a decrease in phosphorus in the compliant group (5.6 ± 1.6 to 4.9 ± 1.7 mg/dl, p = 0.004), there were no significant difference in bone/mineral or anemia parameters including dosing of darbepoetin. An ergocalciferol-prescribing strategy using the KDOQI guidelines for stage III-IV kidney disease in HD patients with VitD deficiency or insufficiency is inadequate to achieve repletion or maintenance of normal VitD levels. Copyright © 2013 S. Karger AG, Basel.

  16. Efficacy and safety of Vitamin D supplementation during pregnancy: A randomized trial of two different levels of dosing on maternal and neonatal Vitamin D outcome

    PubMed Central

    Mir, Shahnaz Ahmad; Masoodi, Shariq Rashid; Shafi, Shafia; Hameed, Iqra; Dar, Maqsood Ahmad; Bashir, Mir Iftikhar; Wani, Arshad Iqbal; Shah, Zaffar Amin; Parveen, Shameema; Zargar, Abdul Hamid; Shah, Parviz Ahmad

    2016-01-01

    Introduction: Pregnant women represent a typical group susceptible to dietary and mineral deficiencies. This study was sought to assess the efficacy and safety of various doses of 25-hydroxyvitamin D (25[OH]D) supplementation during pregnancy and ratify the inadequacy of the recommended daily allowance for Vitamin D in vulnerable groups. Materials and Methods: A total of 100 pregnant women were included in this open-label, parallel group, prospective, randomized, and controlled trial. Study subjects were assigned to four treatment groups: Group 1 (n = 26), 1000 IU of Vitamin D daily; Group 2 (n = 21), 30,000 IU of Vitamin D monthly; Group 3 (n = 27), 2000 IU of Vitamin D daily; and Group 4 (n = 26), 60,000 IU Vitamin D monthly. Group 1 and 2 were further analyzed together as Group 1K (1000 IU daily and 30,000 IU monthly), and Group 3 and 4 as Group 2K (2000 IU daily and 60,000 IU monthly). The analysis was done on an intention to treat basis. Results: A total of 87 patients completed the study; 21 in Group 1, 25 in Group 2, 18 in Group 3, and 23 in Group 4. The levels of 25(OH)D at baseline ranged from 1.3 to 58.0 with a mean of 24.2 ± 15.1 ng/ml. Postsupplementation, 25(OH)D levels ranged from 11.5 to 70.3 with a mean of 40.2 ± 12.2 ng/ml. The postsupplementation levels of 25(OH)D were higher in Group 2K (42.86 ± 12.83) than in Group 1K (36.96 ± 10.56) with P value of 0.023. Conclusion: We concluded that Vitamin D supplementation with 2000 IU/day or 60,000 IU/month is very effective and safe in achieving Vitamin D sufficiency in pregnant women. PMID:27186550

  17. Supplements and athletes.

    PubMed

    Lombardo, John A

    2004-09-01

    Supplements have become a staple with athletes. Athletes take supplements to enhance their performance through replenishment of real and perceived deficiencies, anabolic action of stimulants, increased energy and alertness, and for weight control. Physicians who deal with athletes should be aware of the supplements being utilized by athletes, the athletes' desired effects and the efficacy of the supplement, the adverse effects, and whether the supplement is banned by leagues or organizations in which the athletes are competing. For those athletes who are regularly drug tested for performance enhancers, it is important to remember that one cannot be 100% sure that any supplement will not result in a positive drug test, because there is no independent agency certifying purity.

  18. Efficacy of Aloe Vera Supplementation on Prediabetes and Early Non-Treated Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Zhang, Yiyi; Liu, Wen; Liu, Dan; Zhao, Tieyun; Tian, Haoming

    2016-01-01

    The aim of this study was to evaluate evidence for the efficacy of aloe vera on managing prediabetes and early non-treated diabetes mellitus. We performed a systematic search of PubMed, Embase, and Cochrane Central Register of Controlled Trials until 28 January 2016. A total of five randomized controlled trials (RCTs) involving 415 participants were included. Compared with the controls, aloe vera supplementation significantly reduced the concentrations of fasting blood glucose (FBG) (p = 0.02; weighed mean difference [WMD]: −30.05 mg/dL; 95% confidence interval [CI]: −54.87 to −5.23 mg/dL), glycosylated hemoglobin A1c (HbA1c) (p < 0.00001; WMD: −0.41%; 95% CI: −0.55% to −0.27%), triglyceride (p = 0.0001), total cholesterol (TC) (p < 0.00001), and low density lipoprotein-cholesterol (LDL-C) (p < 0.00001). Aloe vera was superior to placebo in increasing serum high density lipoprotein-cholesterol (HDL-C) levels (p = 0.04). Only one adverse event was reported. The evidence from RCTs showed that aloe vera might effectively reduce the levels of FBG, HbA1c, triglyceride, TC and LDL-C, and increase the levels of HDL-C on prediabetes and early non-treated diabetic patients. Limited evidence exists about the safety of aloe vera. Given the small number and poor quality of RCTs included in the meta-analysis, these results are inconclusive. A large-scale, well-designed RCT is needed to further address this issue. PMID:27347994

  19. A Pilot Randomized Controlled Clinical Trial to Assess Tolerance and Efficacy of Navy Bean and Rice Bran Supplementation for Lowering Cholesterol in Children.

    PubMed

    Borresen, Erica C; Jenkins-Puccetti, NaNet; Schmitz, Katie; Brown, Dustin G; Pollack, Austin; Fairbanks, Amanda; Wdowik, Melissa; Rao, Sangeeta; Nelson, Tracy L; Luckasen, Gary; Ryan, Elizabeth P

    2017-01-01

    Background: Navy beans and rice bran demonstrate efficacy to regulate serum cholesterol in hypercholesterolemic adults; however, the cardiovascular disease (CVD) protective properties of these foods in children are unknown and merit investigation. Objective: The objectives were to determine whether cooked navy bean powder (NBP) and/or heat-stabilized rice bran (RB) supplementation is tolerable, improves dietary fiber intake in children, and modulates lipid profiles. Methods: Children aged 8 to 13 years at risk for CVD due to abnormal lipids were recruited. Elevated cholesterol levels were defined as total cholesterol ≥180 mg/dL and high-density lipoprotein (HDL) <60 mg/dL; low-density lipoprotein (LDL) ≥100 mg/dL and HDL <60 mg/dL; or non-HDL >100 mg/dL and HDL <60 mg/dL. Participants completed a pilot 4-week, randomized controlled, 4-arm dietary intervention. They consumed study-provided muffins or a smoothie daily that included 0 g NBP or RB (control), 17.5 g NBP, 15 g RB, or a combination 9 g NBP + 8 g RB. Fasting blood was collected at baseline and week 4. Participants also completed 3-day food logs and gastrointestinal health questionnaires. Thirty-eight children completed the trial (n = 9 control, n = 10 NBP, n = 9 RB, and n = 10 NBP + RB groups). Only 3 participants withdrew due to noncompliance of required food consumption. Participants in the intervention groups significantly increased intake of NBP and RB at week 4 (p≤.01). The NBP and NBP + RB groups increased total fiber intake from baseline to week 4 (p=.02 and p=<.01, respectively). HDL-cholesterol was higher in NBP-group participants compared to control at week 4 (P = .02). Conclusion: Increasing NBP and/or RB intake is tolerable for children, and our findings suggest higher daily intakes are needed for a longer duration to induce favorable changes across multiple serum lipid parameters.

  20. Hepatoprotective efficacy of Nigella sativa seeds dietary supplementation against lead acetate-induced oxidative damage in rabbit - Purification and characterization of glutathione peroxidase.

    PubMed

    El-Far, Ali H; Korshom, Mahdy A; Mandour, Abdelwahab A; El-Bessoumy, Ashraf A; El-Sayed, Yasser S

    2017-03-03

    Lead (Pb) is a toxic ubiquitous environmental pollutant that induces hepatotoxicity in both animals and humans. The ability of Nigella saliva seeds (NSS) in ameliorating lead acetate (PbAc)-induced hepatic oxidative damage was investigated using a rabbit model. Forty New Zealand rabbits were given feed and water ad libitum. They were allocated randomly into four groups: control; PbAc (5g/L drinking water); NSS (20g/kg diet) and NSS+PbAc groups. After two months, liver samples were collected and analyzed for malondialdehyde (MDA), glutathione (GSH), glutathione S-transferase (GST) and glutathione peroxidase (GPx) contents. Purification and characterization of GPx were also evaluated. PbAc exposure significantly (p<0.05) increased MDA (lipid peroxidation biomarker) and reduced the GSH levels and the GST and GPx activities. Concurrently supplemented NSS significantly (p<0.05) decreased MDA levels and restored the GSH, GST, and GPx contents successfully. Electrophoretically, the homogeneous GPx preparation from the liver had a specific activity of 30.44 U/mg protein and a yield of 1.31%. The Km values for cumene hydroperoxide were 4.76μM in control, PbAc and NSS+PbAc groups, and 4.09μM in NSS group. The GPx reaction had a temperature optimum 40°C, pH optimum 8 and molecular weight 21 kDa. The obtained data indicated the potent efficacy of NSS against PbAc-induced oxidative stress; that was mediated through induction and activation of antioxidants, particularly GPx and scavenging free radicals. Moreover, the purified hepatic GPx is characterized as a selenoprotein (Se-GPx).

  1. Efficacy of Aloe Vera Supplementation on Prediabetes and Early Non-Treated Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Zhang, Yiyi; Liu, Wen; Liu, Dan; Zhao, Tieyun; Tian, Haoming

    2016-06-23

    The aim of this study was to evaluate evidence for the efficacy of aloe vera on managing prediabetes and early non-treated diabetes mellitus. We performed a systematic search of PubMed, Embase, and Cochrane Central Register of Controlled Trials until 28 January 2016. A total of five randomized controlled trials (RCTs) involving 415 participants were included. Compared with the controls, aloe vera supplementation significantly reduced the concentrations of fasting blood glucose (FBG) (p = 0.02; weighed mean difference [WMD]: -30.05 mg/dL; 95% confidence interval [CI]: -54.87 to -5.23 mg/dL), glycosylated hemoglobin A1c (HbA1c) (p < 0.00001; WMD: -0.41%; 95% CI: -0.55% to -0.27%), triglyceride (p = 0.0001), total cholesterol (TC) (p < 0.00001), and low density lipoprotein-cholesterol (LDL-C) (p < 0.00001). Aloe vera was superior to placebo in increasing serum high density lipoprotein-cholesterol (HDL-C) levels (p = 0.04). Only one adverse event was reported. The evidence from RCTs showed that aloe vera might effectively reduce the levels of FBG, HbA1c, triglyceride, TC and LDL-C, and increase the levels of HDL-C on prediabetes and early non-treated diabetic patients. Limited evidence exists about the safety of aloe vera. Given the small number and poor quality of RCTs included in the meta-analysis, these results are inconclusive. A large-scale, well-designed RCT is needed to further address this issue.

  2. Evaluating the efficacy of three USDA-approved antimicrobial sprays for reducing surrogate Shiga toxin-producing cells of "Escherichia coli on bob veal carcasses

    USDA-ARS?s Scientific Manuscript database

    Shiga toxin-producing Escherichia coli (STEC) have recently been recognized as a problem for the veal industry, suggesting the need for effective antimicrobial intervention strategies throughout processing. Therefore, we evaluated the efficacy of lactic acid (4.5%), Citrilow™ (pH 1.2), and Beefxide®...

  3. The efficacy of bait supplements for improving the rate of discovery of bait stations in the field by the formosan subterranean termite (Isoptera: Rhinotermitidae)

    USDA-ARS?s Scientific Manuscript database

    Field tests of four different bait supplements were conducted in City Park, New Orleans, Louisiana. The four bait supplements tested included two different formulations of decayed material, a sports drink, and the combination of an application of an aqueous solution of Summon Preferred Food SourceTM...

  4. 29 CFR 1952.385 - Changes to approved plans.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Puerto Rico § 1952.385 Changes to... approved Puerto Rico's plan supplement, which is generally identical to the Federal Voluntary Protection... Program. (b) Legislation. (1) On March 29, 1994, the Assistant Secretary approved Puerto Rico's revised...

  5. 29 CFR 1952.385 - Changes to approved plans.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Puerto Rico § 1952.385 Changes to... approved Puerto Rico's plan supplement, which is generally identical to the Federal Voluntary Protection... Program. (b) Legislation. (1) On March 29, 1994, the Assistant Secretary approved Puerto Rico's revised...

  6. 29 CFR 1952.385 - Changes to approved plans.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Puerto Rico § 1952.385 Changes to... approved Puerto Rico's plan supplement, which is generally identical to the Federal Voluntary Protection... Program. (b) Legislation. (1) On March 29, 1994, the Assistant Secretary approved Puerto Rico's revised...

  7. A Pilot Randomized Controlled Clinical Trial to Assess Tolerance and Efficacy of Navy Bean and Rice Bran Supplementation for Lowering Cholesterol in Children

    PubMed Central

    Borresen, Erica C.; Jenkins-Puccetti, NaNet; Schmitz, Katie; Brown, Dustin G.; Pollack, Austin; Fairbanks, Amanda; Wdowik, Melissa; Rao, Sangeeta; Nelson, Tracy L.; Luckasen, Gary; Ryan, Elizabeth P.

    2017-01-01

    Background: Navy beans and rice bran demonstrate efficacy to regulate serum cholesterol in hypercholesterolemic adults; however, the cardiovascular disease (CVD) protective properties of these foods in children are unknown and merit investigation. Objective: The objectives were to determine whether cooked navy bean powder (NBP) and/or heat-stabilized rice bran (RB) supplementation is tolerable, improves dietary fiber intake in children, and modulates lipid profiles. Methods: Children aged 8 to 13 years at risk for CVD due to abnormal lipids were recruited. Elevated cholesterol levels were defined as total cholesterol ≥180 mg/dL and high-density lipoprotein (HDL) <60 mg/dL; low-density lipoprotein (LDL) ≥100 mg/dL and HDL <60 mg/dL; or non-HDL >100 mg/dL and HDL <60 mg/dL. Participants completed a pilot 4-week, randomized controlled, 4-arm dietary intervention. They consumed study-provided muffins or a smoothie daily that included 0 g NBP or RB (control), 17.5 g NBP, 15 g RB, or a combination 9 g NBP + 8 g RB. Fasting blood was collected at baseline and week 4. Participants also completed 3-day food logs and gastrointestinal health questionnaires. Results: Thirty-eight children completed the trial (n = 9 control, n = 10 NBP, n = 9 RB, and n = 10 NBP + RB groups). Only 3 participants withdrew due to noncompliance of required food consumption. Participants in the intervention groups significantly increased intake of NBP and RB at week 4 (p≤.01). The NBP and NBP + RB groups increased total fiber intake from baseline to week 4 (p=.02 and p=<.01, respectively). HDL-cholesterol was higher in NBP-group participants compared to control at week 4 (P = .02). Conclusion: Increasing NBP and/or RB intake is tolerable for children, and our findings suggest higher daily intakes are needed for a longer duration to induce favorable changes across multiple serum lipid parameters. PMID:28345013

  8. Efficacy of L-carnitine supplementation on frailty status and its biomarkers, nutritional status, and physical and cognitive function among prefrail older adults: a double-blind, randomized, placebo-controlled clinical trial.

    PubMed

    Badrasawi, M; Shahar, Suzana; Zahara, A M; Nor Fadilah, R; Singh, Devinder Kaur Ajit

    2016-01-01

    Frailty is a biological syndrome of decreased reserve and resistance to stressors due to decline in multiple physiological systems. Amino acid deficiency, including L-carnitine, has been proposed to be associated with its pathophysiology. Nevertheless, the efficacy of L-carnitine supplementation on frailty status has not been documented. Thus, this study aimed to determine the effect of 10-week L-carnitine supplement (1.5 g/day) on frailty status and its biomarkers and also physical function, cognition, and nutritional status among prefrail older adults in Klang Valley, Malaysia. This study is a randomized, double-blind, placebo-controlled clinical trial conducted among 50 prefrail subjects randomized into two groups (26 in L-carnitine group and 24 in placebo group). Outcome measures include frailty status using Fried criteria and Frailty Index accumulation of deficit, selected frailty biomarkers (interleukin-6, tumor necrosis factor-alpha, and insulin-like growth factor-1), physical function, cognitive function, nutritional status and biochemical profile. The results indicated that the mean scores of Frailty Index score and hand grip test were significantly improved in subjects supplemented with L-carnitine (P<0.05 for both parameters) as compared to no change in the placebo group. Based on Fried criteria, four subjects (three from the L-carnitine group and one from the control group) transited from prefrail status to robust after the intervention. L-carnitine supplementation has a favorable effect on the functional status and fatigue in prefrail older adults.

  9. Efficacy of β-mannanase supplementation to corn-soya bean meal-based diets on growth performance, nutrient digestibility, blood urea nitrogen, faecal coliform and lactic acid bacteria and faecal noxious gas emission in growing pigs.

    PubMed

    Upadhaya, Santi Devi; Park, Jae Won; Lee, Jae Hwan; Kim, In Ho

    2016-01-01

    A study was conducted to determine the efficacy of β-mannanase supplementation to a diet based on corn and soya bean meal (SBM) on growth performance, nutrient digestibility, blood urea nitrogen (BUN), faecal coliforms and lactic acid bacteria, and noxious gas emission in growing pigs. A total of 140 pigs [(Landrace × Yorkshire) × Duroc; average body weight 25 ± 3 kg] were randomly allotted to a 2 × 2 factorial arrangement with dietary treatments consisting of hulled or dehulled SBM without or with supplementation of 400 U β-mannanase/kg. During the 6 weeks of experimental feeding, β-mannanase supplementation had no effect on body weight gain, feed intake and gain:feed (G:F) ratio. Compared with dehulled SBM, feeding hulled SBM caused an increased feed intake of pigs in the entire trial (p = 0.05). The G:F ratio was improved in pigs receiving dehulled SBM (p < 0.05). Dietary treatments did not influence the total tract digestibility of dry matter, nitrogen and gross energy. Enzyme supplementation reduced (p < 0.05) the population of faecal coliforms and tended to reduce the NH3 concentration after 24 h of fermentation in a closed box containing faecal slurry. Feeding hulled SBM tended to reduce NH3 emission on days 3 and 5 of fermentation. In conclusion, mannanase supplementation had no influence on growth performance and nutrient digestibility but showed a positive effect on reducing coliform population and tended to reduce NH3 emission. Dehulled SBM increased G:F ratio and hulled SBM tended to reduce NH3 emission.

  10. A Randomized, Double-blind, Placebo-controlled, Multi-center, Extension Trial Evaluating the Efficacy of a New Oral Supplement in Women with Self-perceived Thinning Hair

    PubMed Central

    Dayan, Steven

    2015-01-01

    Objective: The purpose of this six-month, randomized, double-blind, multi-center, placebo-controlled study was to determine if the administration of a new oral supplement will promote terminal hair growth. Design: A randomized, double-blind study. Setting: Two private practices (dermatology and facial plastics). Participants: Women 21 to 75 years of age with self-perceived thinning hair. Measurements: The primary efficacy endpoint was the change in terminal and vellus hairs in a 4cm2 target area of the scalp after 90 and 180 days of treatment. Secondary endpoints were change in hair diameter and responses to Quality of Life and Self-Assessment questionnaires. Results: Subjects treated with the new oral supplement achieved a significant increase in the number of baseline terminal hairs at 90 and 180 days (for each, p<0.0001, respectively) and were significantly greater then placebo (p<0.0001). Treatment with the new oral supplement was also associated with a significant increase in baseline terminal hair diameter after 90 (p=0.006) and 180 days of treatment (p=0.001) which was significantly greater than placebo at the end of the study (p=0.003). Improvements in hair growth and hair diameter were associated with significant improvement in most responses to Self-Assessment and Quality of Life Questionnaire responses. There were no adverse events. Conclusion: The daily administration of a new oral supplement was associated with significant increases in the number of terminal and vellus hairs and hair diameter. Most study participants believed the use of the oral supplement resulted in significant improvement in skin and hair quality and quality of life. PMID:26705444

  11. Dietary supplements for football.

    PubMed

    Hespel, P; Maughan, R J; Greenhaff, P L

    2006-07-01

    Physical training and competition in football markedly increase the need for macro- and micronutrient intake. This requirement can generally be met by dietary management without the need for dietary supplements. In fact, the efficacy of most supplements available on the market is unproven. In addition, players must be cautious of inadequate product labelling and supplement impurities that may cause a positive drug test. Nonetheless, a number of dietary supplements may beneficially affect football performance. A high endurance capacity is a prerequisite for optimal match performance, particularly if extra time is played. In this context, the potential of low-dose caffeine ingestion (2 - 5 mg . kg body mass(-1)) to enhance endurance performance is well established. However, in the case of football, care must be taken not to overdose because visual information processing might be impaired. Scoring and preventing goals as a rule requires production of high power output. Dietary creatine supplementation (loading dose: 15 - 20 g . day(-1), 4 - 5 days; maintenance dose: 2 - 5 g g . day(-1)) has been found to increase muscle power output, especially during intermittent sprint exercises. Furthermore, creatine intake can augment muscle adaptations to resistance training. Team success and performance also depend on player availability, and thus injury prevention and health maintenance. Glucosamine or chondroitin may be useful in the treatment of joint pain and osteoarthritis, but there is no evidence to support the view that the administration of these supplements will be preventative. Ephedra-containing weight-loss cocktails should certainly be avoided due to reported adverse health effects and positive doping outcomes. Finally, the efficacy of antioxidant or vitamin C intake in excess of the normal recommended dietary dose is equivocal. Responses to dietary supplements can vary substantially between individuals, and therefore the ingestion of any supplement must be assessed

  12. Efficacy of using a combination of rendered protein products as an undegradable intake protein supplement for lactating, winter-calving, beef cows fed bromegrass hay.

    PubMed

    Encinias, A M; Lardy, G P; Leupp, J L; Encinias, H B; Reynolds, L P; Caton, J S

    2005-01-01

    Seventy-two (36 in each of two consecutive years) lactating, British-crossbred cows (609 +/- 19 kg) were used to evaluate effects of feeding a feather meal-blood meal combination on performance by beef cows fed grass hay. Bromegrass hay (9.6% CP, DM basis) was offered ad libitum and intake was measured daily in individual Calan electronic headgates. Acclimation to Calan gates began approximately 20 d after parturition, and treatments were initiated 21 d later. Cows were assigned randomly to one of four treatments (DM basis) for 60 d: 1) nonsupplemented control (CON), 2) energy control (ENG; 790 g/d; 100% beet pulp), 3) degradable intake protein (DIP; 870 g/d; 22% beet pulp and 78% sunflower meal), or 4) undegradable intake protein (UIP; 800 g/d; 62.5% sunflower meal, 30% hydrolyzed feather meal, and 7.5% blood meal). Net energy concentrations of supplements were formulated to provide similar NE(m) intakes (1.36 Mcal/d). The DIP and UIP supplements were calculated to supply similar amounts of DIP (168 g/d) and to supply 64 and 224 g/d of UIP, respectively. Forage DMI (kg/d) decreased in supplemented vs. nonsupplemented (P = 0.03) and DIP vs. UIP (P = 0.001); however, when expressed as a percentage of BW, forage DMI was not different (P = 0.23). Supplemented cows tended (P = 0.17) to lose less BW than CON. Body condition change was not affected (P = 0.60) by postpartum supplementation. No differences were noted in milk production (P = 0.29) or in calf gain during the supplementation period (P = 0.74). Circulating insulin concentrations were not affected by treatment (P = 0.42). In addition, supplementation did not affect circulating concentrations of NEFA (P = 0.18) or plasma urea nitrogen (P = 0.38). Results of the current study indicate that supplementation had little effect on BW, BCS, milk production, or calf BW when a moderate-quality forage (9.6% CP) was fed to postpartum, winter-calving cows in optimal body condition (BCS > 5). Supplemental UIP did not enhance

  13. Ergogenic Aids and Supplements.

    PubMed

    Porrini, Marisa; Del Boʼ, Cristian

    2016-01-01

    Great interest is currently shown for the contribution of nutrition to optimize training and athletic performance, and a considerable debate exists about the potential ergogenic value of several dietary supplements. However, most of the products used by athletes do not provide sufficient scientific evidence regarding their efficacy in enhancing physical performance as well as their specificity of action and safety. For this reason, sport nutrition professionals need skills in evaluating the scientific value of papers and advertisements on ergogenic aids and supplements in order to support athletes in their choice. In the present chapter, the efficacy of some of the most popular supplements used by athletes and sport practitioners will be discussed. Particular attention will be devoted to amino acids and derivatives, caffeine and caffeinated energy drinks, and some antioxidants. © 2016 S. Karger AG, Basel.

  14. A Systematic Review of the Efficacy and Safety Experience Reported for Sorafenib in Advanced Renal Cell Carcinoma (RCC) in the Post-Approval Setting

    PubMed Central

    Fishman, Mayer N.; Tomshine, Jin; Fulp, William J.; Foreman, Pamela K.

    2015-01-01

    Background Sorafenib was FDA approved in 2005 for treatment of renal cell carcinoma (RCC) based on the results of the pivotal phase 3 clinical trial, TARGET (Treatment Approaches in Renal Cancer Global Evaluation Trial). Since that time, numerous clinical studies have been undertaken that substantially broaden our knowledge of the use of sorafenib for this indication. Methods We systematically reviewed PubMed, Web of Science, Embase, Cochrane Library, and www.clinicaltrials.gov for prospective clinical studies using single agent sorafenib in RCC and published since 2005. Primary endpoints of interest were progression-free survival (PFS) and safety. PROSPERO International prospective register of systematic reviews #CRD42014010765. Results We identified 30 studies in which 2182 patients were treated with sorafenib, including 1575 patients who participated in randomized controlled phase 3 trials. In these trials, sorafenib was administered as first-, second- or third-line treatment. Heterogeneity among trial designs and reporting of data precluded statistical comparisons among trials or with TARGET. The PFS appeared shorter in second- vs. first-line treatment, consistent with the more advanced tumor status in the second-line setting. In some trials, incidences of grade 3/4 hypertension or hand-foot skin reaction (HFSR) were more than double that seen in TARGET (4% and 6%, respectively). These variances may be attributable to increased recognition of HFSR, or potentially differences in dose adjustments, that could be consequences of increased familiarity with sorafenib usage. Several small studies enrolled exclusively Asian patients. These studies reported notably longer PFS than was observed in TARGET. However, no obvious corresponding differences in disease control rate and overall survival were seen. Conclusions Collectively, more recent experiences using sorafenib in RCC are consistent with results reported for TARGET with no marked changes of response endpoints or

  15. FDA-Approved Natural Polymers for Fast Dissolving Tablets

    PubMed Central

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets. PMID:26556207

  16. FDA-Approved Natural Polymers for Fast Dissolving Tablets.

    PubMed

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets.

  17. Safety and efficacy of a ginkgo biloba-containing dietary supplement on cognitive function, quality of life, and platelet function in healthy, cognitively intact older adults.

    PubMed

    Carlson, Joseph J; Farquhar, John W; DiNucci, Ellen; Ausserer, Laurie; Zehnder, James; Miller, Donald; Berra, Kathy; Hagerty, Lisa; Haskell, William L

    2007-03-01

    To determine if a ginkgo biloba-containing supplement improves cognitive function and quality of life, alters primary hemostasis, and is safe in healthy, cognitively intact older adults. Four-month, randomized, double-blind, placebo-controlled parallel design. Ninety men and women (age range 65 to 84 years) were recruited to a university clinic. Eligibility included those without dementia or depression, not taking psychoactive medications or medications or supplements that alter hemostasis. Ninety subjects were randomly assigned to placebo or a ginkgo biloba-based supplement containing 160 mg ginkgo biloba, 68 mg gotu kola, and 180 mg decosahexaenoic acid per day for 4 months. Assessments included: six standardized cognitive function tests, the SF-36 Quality of Life questionnaire, the Platelet Function Analyzer-100 (Dade Behring, Eschbom, Germany), and the monitoring of adverse events. Baseline characteristics and study hypotheses were tested using analysis of covariance. Tests were two-tailed with a 0.05 significance level. Seventy-eight subjects (87%) completed both baseline and 4-month testing (n=36 in placebo group, n=42 in ginkgo biloba group). At baseline, the participants' cognitive function was above average. One of six cognitive tests indicated significant protocol differences at 4 months (P=0.03), favoring the placebo. There were no significant differences in quality of life, platelet function, or adverse events. These finding do not support the use of a ginkgo biloba-containing supplement for improving cognitive function or quality of life in cognitively intact, older, healthy adults. However, high baseline scores may have contributed to the null findings. The ginkgo biloba product seems safe and did not alter platelet function, though additional studies are needed to evaluate the interaction of varying doses of ginkgo biloba and ginkgo biloba-containing supplements with medications and supplements that alter hemostasis.

  18. Parenteral iron supplementation.

    PubMed

    Kumpf, V J

    1996-08-01

    Indications for the use of parenteral iron are limited to conditions in which the oral supplementation of iron is not possible or fails. An overview of iron balance and iron requirements is presented to describe situations in which iron supplementation may be required. When parenteral iron supplementation is required, careful attention to proper dosing and administration is necessary to optimize efficacy and safety. The purpose of this article is to review the literature regarding the clinical use of parenteral iron therapy and provide guidelines on dosing and administration. Methods of iron dextran administration, including the IV and intramuscular injection of undiluted drug and total dose infusion, are compared. Complications associated with the use of parenteral iron are also be reviewed. Finally, the use of iron supplementation in patients receiving parenteral nutrition care explored.

  19. Narrative review of the safety and efficacy of marijuana for the treatment of commonly state-approved medical and psychiatric disorders.

    PubMed

    Belendiuk, Katherine A; Baldini, Lisa L; Bonn-Miller, Marcel O

    2015-04-21

    The present investigation aimed to provide an objective narrative review of the existing literature pertaining to the benefits and harms of marijuana use for the treatment of the most common medical and psychological conditions for which it has been allowed at the state level. Common medical conditions for which marijuana is allowed (i.e., those conditions shared by at least 80 percent of medical marijuana states) were identified as: Alzheimer's disease, amyotrophic lateral sclerosis, cachexia/wasting syndrome, cancer, Crohn's disease, epilepsy and seizures, glaucoma, hepatitis C virus, human immunodeficiency virus/acquired immunodeficiency syndrome, multiple sclerosis and muscle spasticity, severe and chronic pain, and severe nausea. Post-traumatic stress disorder was also included in the review, as it is the sole psychological disorder for which medical marijuana has been allowed. Studies for this narrative review were included based on a literature search in PsycINFO, MEDLINE, and Google Scholar. Findings indicate that, for the majority of these conditions, there is insufficient evidence to support the recommendation of medical marijuana at this time. A significant amount of rigorous research is needed to definitively ascertain the potential implications of marijuana for these conditions. It is important for such work to not only examine the effects of smoked marijuana preparations, but also to compare its safety, tolerability, and efficacy in relation to existing pharmacological treatments.

  20. The Efficacy of Instructor-Guided Supplemental Instruction as a Strategy for Helping Reading-Deficient College Students Improve Testing and Assessment Outcomes

    ERIC Educational Resources Information Center

    Bartley-Lukula, Audrey

    2013-01-01

    This research project examined whether the use of Instructor-guided Supplemental Instruction as a classroom scaffolding technique, might help improve testing and assessment reading outcomes for reading-deficient college students. The study was completed at Tennessee State University in Nashville, Tennessee over the 16-week Fall, 2012 semester…

  1. The Efficacy of Instructor-Guided Supplemental Instruction as a Strategy for Helping Reading-Deficient College Students Improve Testing and Assessment Outcomes

    ERIC Educational Resources Information Center

    Bartley-Lukula, Audrey

    2013-01-01

    This research project examined whether the use of Instructor-guided Supplemental Instruction as a classroom scaffolding technique, might help improve testing and assessment reading outcomes for reading-deficient college students. The study was completed at Tennessee State University in Nashville, Tennessee over the 16-week Fall, 2012 semester…

  2. Folate/Folic Acid Knowledge, Intake, and Self-Efficacy of College-Aged Women: Impact of Text Messaging and Availability of a Folic Acid-Containing Supplement

    ERIC Educational Resources Information Center

    Rampersaud, Gail C.; Sokolow, Andrew; Gruspe, Abigail; Colee, James C.; Kauwell, Gail P. A.

    2016-01-01

    Objective: To evaluate the impact of educational text messages (TMs) on folate/folic acid knowledge and consumption among college-aged women, and to evaluate the impact of providing folic acid supplements on folate/folic acid intake among college-aged women. Participants: A total of 162 women (18-24 years) recruited from a university. Methods: The…

  3. Antimicrobial effect of the Biotronic® Top3 supplement and efficacy in protecting rainbow trout (Oncorhynchus mykiss) from infection by Aeromonas salmonicida subsp. salmonicida.

    PubMed

    Menanteau-Ledouble, Simon; Krauss, Ines; Goncalves, Rui Alexandre; Weber, Barbara; Santos, Gonçalo Abreu; El-Matbouli, Mansour

    2017-03-18

    Demand for more environmentally friendly practices have led to the adoption of several feed supplements by the fish farming industry. In the present study, we investigated a commercially available formula that includes a mixture of three compounds: organic acids, a phytochemical and Biomin® Permeabilizing Complex. This mixture demonstrated antimicrobial properties in vitro and was able to inhibit growth of multiple species of aquatic bacterial pathogens, including Aeromonas salmonicida. Bacterial challenge was performed using A. salmonicida and three exposure routes: intra-peritoneal injection, immersion, and cohabitation. Mortality rates following infection by injection were significantly decreased in the fish that had received the supplemented feed. Fish infected through the other routes did not show a significant difference in mortality. In term of farming performance, while the fish that had received the feed supplement showed an improvement in weight gain and final weight, these changes were not found to be statistically significant. Similarly, no significant difference was observed in the feed conversion ratio. The results of this study suggest that this feed supplement may be effective at protecting rainbow trout from fish furunculosis.

  4. Folate/Folic Acid Knowledge, Intake, and Self-Efficacy of College-Aged Women: Impact of Text Messaging and Availability of a Folic Acid-Containing Supplement

    ERIC Educational Resources Information Center

    Rampersaud, Gail C.; Sokolow, Andrew; Gruspe, Abigail; Colee, James C.; Kauwell, Gail P. A.

    2016-01-01

    Objective: To evaluate the impact of educational text messages (TMs) on folate/folic acid knowledge and consumption among college-aged women, and to evaluate the impact of providing folic acid supplements on folate/folic acid intake among college-aged women. Participants: A total of 162 women (18-24 years) recruited from a university. Methods: The…

  5. The efficacy of micronutrient supplementation in reducing the prevalence of anaemia and deficiencies of zinc and iron among adolescents in Sri Lanka

    USDA-ARS?s Scientific Manuscript database

    Objective: To determine the effectiveness of combined iron and zinc over the iron- or zinc-only supplementation in correcting deficiency and possible interactive effects in a group of adolescent school children. Subjects and methods: Schoolchildren (n=821) of 12–16 years of age were randomized into ...

  6. Efficacy of whey protein supplementation on resistance exercise-induced changes in muscle strength, lean mass, and function in mobility-limited older adults

    USDA-ARS?s Scientific Manuscript database

    Whey protein supplementation may augment resistance exercise-induced increases in muscle strength and mass. Further studies are required to determine whether this effect extends to functionally compromised older adults. The objectives of the study were to compare the effects of whey protein concent...

  7. An overview of herb and dietary supplement efficacy, safety and government regulations in the United States with suggested improvements. Part 1 of 5 series.

    PubMed

    Brown, Amy Christine

    2017-09-01

    This is the first of five review articles investigating dietary supplements (DS; includes herbs) that now exceed over 50,000 in the Office of Dietary Supplement's "Dietary Supplement Label Database." Four review articles follow summarizing published medical case reports of DS related to liver toxicity, kidney toxicity, heart toxicity, and cancer. The most popular DS were vitamin or mineral supplements (43%) followed by specialty supplements (20%), botanicals (20%; herbs), and sports supplements (16%). The 2013 Annual Report of the American Association of Poison Control Centers revealed 1692 fatalities due to drugs, and zero deaths due to DS. Less than 1 percent of Americans experience adverse events related to DS, and the majority was classified as minor, with many of these related to caffeine, yohimbe, or other stimulant ingredients. The number one adulterant in DS is drugs, followed by New Dietary Ingredients (NDI) not submitted to the FDA - both are illegal and not DS, but rather "tainted products marketed as dietary supplements." The three main categories of DS prone to medical problems are those for sexual enhancement, weight loss, and sports performance/body building. DS are regulated in the U.S. by several federal agencies with overlapping jurisdiction - the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC); enforced by the State Attorneys General Offices (AGO) and Department of Justice (DOJ); and monitored (not regulated) by the Centers for Disease Control and Prevention (CDC). The FDA can remove a DS from the market for phase IV post-marketing surveillance adverse event reports, adulteration (drugs, NDI, synthetic substances), contamination, misidentification, mislabeling or false claims, and not meeting good manufacturing practices (GMP). The FTC and state AGO can also enforce laws against deceptive marketing practices. Suggested improvements to current regulatory requirements are included along with online DS Toxic Tables in the

  8. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. (a... before making a change affecting the safety or effectiveness of the device for which the applicant has...

  9. The efficacy of vitamin E (DL-alpha-tocopheryl acetate) supplementation in hen diets to alleviate egg quality deterioration associated with high temperature exposure.

    PubMed

    Kirunda, D F; Scheideler, S E; McKee, S R

    2001-09-01

    Supplementation of hen diets with vitamin E was investigated as a means to alleviate egg quality deterioration associated with high temperature exposure. One hundred eighty layers (60 birds/diet) were randomly placed on diets supplemented with vitamin E at 20, 60, and 120 IU/kg feed. After 2 wk on feed, one-half of the birds were maintained at environmental temperatures of 21 C, whereas the other half were acclimated over 3 d to increasing environmental temperatures reaching 34 C. Birds were exposed to 21 or 34 C for 2 wk (five hens per cage x six replications). Egg production, feed intake, and egg weights were determined daily. Twenty eggs were collected from each treatment group and analyzed for vitamin E content in yolk, percentage egg solids, yolk color, yolk pH, albumen pH, foaming ability of albumen proteins, emulsification capacity of yolk, yolk viscosity, yolk color, and vitelline membrane strength (VMS). Results suggested that high temperature exposure (HTE) caused a reduction in feed intake, egg production, Haugh units, egg weights, VMS, yolk and albumen solids, foam stability, angel cake volume, yolk color, and emulsification capacity. Supplementation of HTE hen diets with 60 IU vitamin E/kg feed improved feed intake, egg production, VMS, yolk and albumen solids, foam stability, and angel cake volume. However, egg weight, emulsification capacity, yolk color, yolk index, and yolk viscosity were not improved by vitamin E supplementation of HTE hens. Vitamin E levels in the yolk were lower from HTE hens compared with controls at all levels of vitamin E supplementation.

  10. Efficacy of L-carnitine supplementation on frailty status and its biomarkers, nutritional status, and physical and cognitive function among prefrail older adults: a double-blind, randomized, placebo-controlled clinical trial

    PubMed Central

    Badrasawi, M; Shahar, Suzana; Zahara, AM; Nor Fadilah, R; Singh, Devinder Kaur Ajit

    2016-01-01

    Background Frailty is a biological syndrome of decreased reserve and resistance to stressors due to decline in multiple physiological systems. Amino acid deficiency, including L-carnitine, has been proposed to be associated with its pathophysiology. Nevertheless, the efficacy of L-carnitine supplementation on frailty status has not been documented. Thus, this study aimed to determine the effect of 10-week L-carnitine supplement (1.5 g/day) on frailty status and its biomarkers and also physical function, cognition, and nutritional status among prefrail older adults in Klang Valley, Malaysia. Methodology This study is a randomized, double-blind, placebo-controlled clinical trial conducted among 50 prefrail subjects randomized into two groups (26 in L-carnitine group and 24 in placebo group). Outcome measures include frailty status using Fried criteria and Frailty Index accumulation of deficit, selected frailty biomarkers (interleukin-6, tumor necrosis factor-alpha, and insulin-like growth factor-1), physical function, cognitive function, nutritional status and biochemical profile. Results The results indicated that the mean scores of Frailty Index score and hand grip test were significantly improved in subjects supplemented with L-carnitine (P<0.05 for both parameters) as compared to no change in the placebo group. Based on Fried criteria, four subjects (three from the L-carnitine group and one from the control group) transited from prefrail status to robust after the intervention. Conclusion L-carnitine supplementation has a favorable effect on the functional status and fatigue in prefrail older adults. PMID:27895474

  11. The C677T MTHFR genotypes influence the efficacy of B9 and B12 vitamins supplementation to lowering plasma total homocysteine in hemodialysis.

    PubMed

    Achour, Ons; Elmtaoua, Sahbi; Zellama, Dorsaf; Omezzine, Asma; Moussa, Amira; Rejeb, Jihene; Boumaiza, Imene; Bouacida, Lobna; Rejeb, Nabila Ben; Achour, Abdellatif; Bouslama, Ali

    2016-10-01

    Hyperhomocysteinaemia, an independent risk factor for cardiovascular diseases, is common in hemodialysis patients (HD) and particularly in those homozygous for polymorphism of the 5,10-methylenetetrahydrofolate reductase (MTHFR) gene. B vitamins supplementation has been shown to lower plasma total homocysteine (tHcy), but this has been contreversed in several groups. The aim of our study was to explore the response of tHcy in hemodialysis (HD) patients to individual supplementation with folic acid (B9) and/or vitamin B12, based on carrier status for the (MTHFR) polymorphism. 132HD were randomized according to C677TMTHFR genotypes into 2 groups (AandB). The group (A) was treated initially with B9 (10mg/day orally) for 2 months (t1) and then with B12 vitamin (cyanocobalamin ampoule of 1000 μg) for the following 2 months (t2), then association of B9 and B12 for 2 months (t3). The group (B) was supplemented initially with vitamin B12 (t1), then with folic acid (t2) and then B9 + B12 for 2 months (t3). A wash-out period of 2 months followed the treatment in both groups (t4). We determined tHcy, B9 and B12 concentrations at each time. In group A, we noted that the decrease in tHcy becomes significant for CC when patients were supplemented with vit B12 only (p = 0.009). While, B9 + vit B12 supplementation did not seem to improve a significant effect compared with B12 alone. For genotypes (CT) and (TT) we noticed a significant decrease in tHcy at t1 (p = 0.038; 0.005 respectively) and at (t3; CT p = 0.024; TT p = 0.017). In group B, for genotypes CC, the decrease in tHcy became significant at t3 (vit B12 + B9; p = 0.031). For genotypes (CT) and (TT), at the replacement of vit B12 by B9, tHcy was significantly decreased (p = 0.036; 0.012, respectively). The combination of the 2 vitamins (t3) showed no difference compared to folate alone. In the 2 groups (t4), there was an significant increase of tHcy again for 3 genotypes. Supplementation with B

  12. An innovative solid oral nutritional supplement to fight weight loss and anorexia: open, randomised controlled trial of efficacy in institutionalised, malnourished older adults.

    PubMed

    Pouyssegur, Valerie; Brocker, Patrice; Schneider, Stéphane M; Philip, Jean Luc; Barat, Philippe; Reichert, Ewa; Breugnon, Frederic; Brunet, Didier; Civalleri, Bruno; Solere, Jean Paul; Bensussan, Line; Lupi-Pegurier, Laurence

    2015-03-01

    To evaluate the impact of a solid nutritional supplement on the weight gain of institutionalised older adults>70 years with protein-energy malnutrition. The innovation of these high-protein and high-energy cookies was the texture adapted to edentulous patients (Protibis®, Solidages, France). An open, multicentre, randomised controlled trial. Seven nursing homes. One hundred and seventy-five malnourished older adults, aged 86±8 years. All participants received the standard institutional diet. In addition, Intervention group participants received eight cookies daily (11.5 g protein; 244 kcal) for 6 weeks (w0-w6). Five visits (w-4, w0, w6, w10 and w18). Percentage of weight gain from w0 to w6 (body mass in kg). Appetite, rated using a numerical scale (0: no appetite to 10: extremely good appetite); current episodes of pressure ulcers and diarrhea. Average weight increased in Intervention group (n=88) compared with Control group (n=87) without cookies supplementation (+1.6 versus -0.7%, P=0.038). Weight gain persisted 1 month (+3.0 versus -0.2%, P=0.025) and 3 months after the end of cookies consumption (+3.9 versus -0.9%, P=0.003), with diarrhea reduction (P=0.027). There was a synergistic effect with liquid/creamy dietary supplements. Subgroup analysis confirmed the positive impact of cookies supplementation alone on weight increase (P=0.024), appetite increase (P=0.009) and pressure ulcers reduction (P=0.031). The trial suggested that, to fight against anorexia, the stimulation of touch (finger food; chewing, even on edentulous gums) and hearing (intra-oral sounds) could be valuable alternatives to sight, smell and taste alterations. © The Author 2014. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  13. Insufficient documentation for clinical efficacy of selenium supplementation in chronic autoimmune thyroiditis, based on a systematic review and meta-analysis.

    PubMed

    Winther, Kristian Hillert; Wichman, Johanna Eva Märta; Bonnema, Steen Joop; Hegedüs, Laszlo

    2017-02-01

    By a systematic review and meta-analysis to investigate clinically relevant effects of selenium supplementation in patients with chronic autoimmune thyroiditis. Controlled trials in adults (≥18 years) with autoimmune thyroiditis, comparing selenium with or without levothyroxine substitution, versus placebo and/or levothyroxine substitution, were eligible for inclusion. Identified outcomes were serum thyrotropin (thyroid stimulating hormone) levels in LT4-untreated patients, thyroid ultrasound and health-related quality of life. Eleven publications, covering nine controlled trials, were included in the systematic review. Random effects model meta-analyses were performed in weighted mean difference for thyroid stimulating hormone, ultrasound and health-related quality of life. Quality of evidence was assessed per outcome, using GRADE. Meta-analyses showed no change in thyroid stimulating hormone, or improvements in health-related quality of life or thyroid echogenicity (ultrasound), between levothyroxine substitution-untreated patients assigned to selenium supplementation or placebo. Three trials found some improvement in wellbeing in patients receiving levothyroxine substitution, but could not be synthesized in a meta-analysis. The quality of evidence ranged from very low to low for thyroid stimulating hormone as well as ultrasound outcomes, and low to moderate for health-related quality of life, and was generally downgraded due to small sample sizes. We found no effect of selenium supplementation on thyroid stimulating hormone, health-related quality of life or thyroid ultrasound, in levothyroxine substitution-untreated individuals, and sporadic evaluation of clinically relevant outcomes in levothyroxine substitution-treated patients. Future well-powered RCTs, evaluating e.g. disease progression or health-related quality of life, are warranted before determining the relevance of selenium supplementation in autoimmune thyroiditis.

  14. Chitinolytic Streptomyces vinaceusdrappus S5MW2 isolated from Chilika lake, India enhances plant growth and biocontrol efficacy through chitin supplementation against Rhizoctonia solani.

    PubMed

    Yandigeri, Mahesh S; Malviya, Nityanand; Solanki, Manoj Kumar; Shrivastava, Pooja; Sivakumar, G

    2015-08-01

    A chitinolytic actinomycete Streptomyces vinaceusdrappus S5MW2 was isolated from water sample of Chilika lake, India and identified using 16S rRNA gene sequencing. It showed in vitro antifungal activity against the sclerotia producing pathogen Rhizoctonia solani in a dual culture assay and by chitinase enzyme production in a chitin supplemented minimal broth. Moreover, isolate S5MW2 was further characterized for biocontrol (BC) and plant growth promoting features in a greenhouse experiment with or without colloidal chitin (CC). Results of greenhouse experiment showed that CC supplementation with S5MW2 showed a significant growth of tomato plants and superior disease reduction as compared to untreated control and without CC treated plants. Moreover, higher accumulation of chitinase also recovered in the CC supplemented plants. Significant effect of CC also concurred with the Analysis of Variance of greenhouse parameters. These results show that the a marine antagonist S5MW2 has BC efficiency against R. solani and chitinase enzyme played important role in plant resistance.

  15. Efficacy of bait supplements for improving the rate of discovery of bait stations in the field by formosan subterranean termites (Isoptera: Rhinotermitidae).

    PubMed

    Cornelius, Mary L; Lyn, Margaret; Williams, Kelley S; Lovisa, Mary P; De Lucca, Anthony J; Lax, Alan R

    2009-06-01

    Field tests of four different bait supplements were conducted in City Park, New Orleans, LA. The four bait supplements tested included two different formulations of decayed material, a sports drink, and the combination of an application of an aqueous solution of Summon Preferred Food Source disks with the disk itself. Although all the bait supplements in this study resulted in a slightly greater number of treated stations discovered compared with control stations, only the application of the aqueous solution combined with the disk caused a significant increase in the number of stations discovered by termites. This treatment resulted in a significantly greater rate of discovery of treated stations versus control stations after only 14 d in the field. Termites were able to discover six times as many treated as control stations after 14 d, 9 times as many after 28 d, and 12 times as many after 42 d. These findings provide evidence that the diffusion of an aqueous solution into the soil underneath monitoring stations significantly decreased the length of time required for termites to infest stations.

  16. Adequacy of hyaluronan binding assay and a new fertility index derived from it for measuring of male fertility potential and the efficacy of supplement therapy.

    PubMed

    Szucs, M; Osvath, P; Laczko, I; Jakab, A

    2015-06-01

    The aim of the study was to statistically prove that the HBA(®) test is an efficient practical method for andrologists to determine the fertility potential as well as to measure the efficiency of oral supplement therapy in case of male infertility. In the study, 175 patients were involved and it also included the follow-up studies of 39 patients after supplement therapy. Completing the 'classic' spermatological parameters with the results of HBA(®) test, the authors have also determined a new fertility index to be used for practical rating of the measure of fertility potential. After the supplement therapy, both sperm density and hyaluronan binding capacity increased significantly. The authors are convinced that the HBA(®) analysis is an objective, standardisable test, which provides a better approach to fertility potential. This analysis enables us to detect spermatozoa that were previously misjudged as normal by morphological assay and also makes the efficiency of the therapy more measurable. © 2014 Blackwell Verlag GmbH.

  17. Efficacy of high dose Vitamin D supplementation in improving serum 25(OH)D among migrant and non migrant population: a retrospective study.

    PubMed

    Gowda, Usha; Ruwanpathirana, Thilanga; Fong, David P S; Kaur, Ambika; Renzaho, Andre M N

    2016-10-13

    Higher dose of vitamin D supplementation 50000 IU is required for those whose serum 25(OH)D levels are 50 nmol/L and below. The increment in serum 25(OH)D though not significantly affected by race, sex or age it is negatively correlated to the baseline 25(OH)D concentration. This study investigated whether the mean increase in serum 25(OH)D will be higher among participants with lower baseline 25(OH)D levels and whether the duration of supplementation has an influence on the serum 25(OH)D achieved. A clinical audit of patients' medical records from a community health centre in Melbourne for the period 01.01.2010 to 31-12.2012 was undertaken. Paired sample t test was used to determine difference in pre and post dose serum 25(OH)D. Simple and multiple linear regressions were used to examine the association between the difference in pre and post dose serum 25(OH)D and duration of supplementation and baseline serum 25(OH)D, adjusting for socio-demographic factors. A total of 205 patients were included in the study. Mean difference in serum 25(OH)D was highest 52.8 nmol/L (95 % CI: 46.63-58.92) among those whose serum 25(OH)D was below 25 nmol/L at baseline. Baseline 25(OH)D alone accounted for 13.7 % of variance in the effect size (F(2, 202) = 16.0. p < 0.001), with the effect size significantly higher among participants with a baseline 25(OH)D level of 25-49 nmol/L (β = 11.93, 95 % CI: 0.48, 23.40, p < 0.05). Mean serum 25(OH)D difference was highest, 47.53 nmol/L (95 % CI: 40.95-54.11) when measured within 3 months of supplementation. Duration of supplementation explained 2.9 % of the variance in the effect size (F (1, 203) = 6.11, p < 0.05) and there was an inverse relationship between the length of supplementation and mean pre and post supplementation serum 25(OH)D difference (β = -1.45, 95 % CI: -2.62, -0.29, p = 0.014). Following 50000 IU vitamin D3 for 12 months mean serum 25(OH)D increase was highest among those

  18. A family 11 carbohydrate-binding module (CBM) improves the efficacy of a recombinant cellulase used to supplement barley-based diets for broilers at lower dosage rates.

    PubMed

    Ribeiro, T; Ponte, P I P; Guerreiro, C I P D; Santos, H M; Falcão, L; Freire, J P B; Ferreira, L M A; Prates, J A M; Fontes, C M G A; Lordelo, M M

    2008-09-01

    1. Exogenous microbial beta-1,3-1,4-glucanases and hemicellulases contribute to improving the nutritive value of cereals rich in soluble non-starch polysaccharides for poultry. 2. In general, plant cell wall hydrolases display a modular structure comprising a catalytic module linked to one or more non-catalytic carbohydrate-binding modules (CBMs). Based on primary structure similarity, CBMs have been classified in 50 different families. CBMs anchor cellulases and hemicellulases into their target substrates, therefore eliciting efficient hydrolysis of recalcitrant polysaccharides. 3. A study was undertaken to investigate the effects of a family 11 beta-glucan-binding domain in the function of recombinant derivatives of cellulase CtLic26A-Cel5E of Clostridium thermocellum that were used to supplement a barley-based diet at lower dosage rates. 4. The results showed that birds fed on diets supplemented with the recombinant CtLic26A-Cel5E modular derivative containing the family 11 CBM or the commercial enzyme mixture Rovabio Excel AP tended to display improved performance when compared to birds fed diets not supplemented with exogenous enzymes. 5. It is suggested that at lower than previously reported enzyme dosage (10 U/kg vs 30 U/kg of basal diet), the beta-glucan-binding domain also elicits the function of the recombinant CtLic26A-Cel5E derivatives. 6. Finally, the data suggest that exogenous enzymes added to barley-based diets act primarily in the proximal section of the gastrointestinal tract.

  19. Scientific skepticism and new discoveries: an analysis of a report of zinc/phytase supplementation and the efficacy of botulinum toxins in treating cosmetic facial rhytides, hemifacial spasm and benign essential blepharospasm.

    PubMed

    Cohen, Joel L

    2014-10-01

    A recent paper in the Journal of Drugs in Dermatology by Koshy and colleagues (2012, 11( 4 ):507-512) report on "Effect of Dietary Zinc and Phytase Supplementation on Botulinum Toxin Treatments" and conclude by claiming the discovery of "a potentially meaningful role for zinc and/or phytase supplementation in increasing the degree and duration of botulinum toxin effect in the treatment of cosmetic facial rhytids, benign essential blepharospasm, and hemifacial spasm". The purpose of this paper is to examine these published claims for possible methodological and design errors and potential sources of bias. The authors evaluated the published results in comparison to the published literature on zinc deficiency, the role of phytase, prior reports of an effect of zinc on activity of botulinum toxin, issues of study design and execution and if the reported results of the study supported the study's conclusions. Multiple issues are present in the reported study, which appear to invalidate its conclusions. These areas include lack of direct evidence for the presence of clinical or subclinical zinc deficiency in the study population or for the level of phytate in the study population sufficient to interfere with zinc absorption in these subjects. Additionally, there is ambiguity as to the actual dose of zinc used as well as in the study design itself. Also there is a failure of the study through the "unmasking" of the crossover design. There is potential financial conflict of interest in the study execution that may have biased the reported results. Finally there is inadequate data presented to evaluate the claims made of a "new discovery" as to the three disease entities reported on and the various botulinum toxins used in each of the three treatment arms of the study. Based on this evaluation, it appears that a high level of clinical and scientific skepticism is warranted concerning any claim of a beneficial effect of zinc and phytase supplementation on the efficacy or

  20. Dietary supplements.

    PubMed

    Massey, Patrick B

    2002-01-01

    The amount of published information on dietary supplements mushroomed in the 1990s. In fewer than 5 years, publications increased at least 100-fold in the medical literature alone. Dietary supplements are an uncharted territory that warrants complete and accurate exploration. One should not be surprised that disease and illness may respond to dietary supplements. Nutrition is the foundation to good health, and dietary supplements may prove to be some of the most powerful medicines ever discovered. An especially exciting discovery is that dietary supplements may enhance the effects of specific drugs. This discovery may lead to more effective and safer protocols for the treatment of cancer, heart and lung disease, and a host of chronic medical conditions. Information about dietary supplements is becoming more common in the popular medical literature and is creating increased curiosity and an increased awareness. The explosion of the dietary supplement market is compelling physicians to become aware of dietary supplements. Whether or not they are used in clinical practice is a decision for the individual physician. Given the increasing number of patients who are using dietary supplements, however, it is imperative that physicians have a good understanding of this topic. Considering the increasing complexity and magnitude of this topic, physician specialization may be essential. There are many good reference books, review articles, and internet sites on specific supplements that probably should be part of every physician's reference library. The accompanying box provides a brief list of such sources.

  1. 5 CFR 8101.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... 8101.103 Section 8101.103 Administrative Personnel CONSUMER PRODUCT SAFETY COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE CONSUMER PRODUCT SAFETY COMMISSION § 8101.103 Prior approval for outside employment. (a) Prior approval requirement. Before engaging in any outside...

  2. 5 CFR 8101.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... 8101.103 Section 8101.103 Administrative Personnel CONSUMER PRODUCT SAFETY COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE CONSUMER PRODUCT SAFETY COMMISSION § 8101.103 Prior approval for outside employment. (a) Prior approval requirement. Before engaging in any outside...

  3. 5 CFR 8101.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... 8101.103 Section 8101.103 Administrative Personnel CONSUMER PRODUCT SAFETY COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE CONSUMER PRODUCT SAFETY COMMISSION § 8101.103 Prior approval for outside employment. (a) Prior approval requirement. Before engaging in any outside...

  4. 5 CFR 8101.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... 8101.103 Section 8101.103 Administrative Personnel CONSUMER PRODUCT SAFETY COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE CONSUMER PRODUCT SAFETY COMMISSION § 8101.103 Prior approval for outside employment. (a) Prior approval requirement. Before engaging in any outside...

  5. 14 CFR 121.162 - ETOPS Type Design Approval Basis.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false ETOPS Type Design Approval Basis. 121.162... REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Aircraft Requirements § 121.162 ETOPS Type Design Approval Basis. Except for a passenger-carrying airplane with more than two engines manufactured prior to...

  6. 10 CFR 35.8 - Information collection requirements: OMB approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 35.8 Section 35.8 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information..., including NRC Form 313A, which licensees may use to provide supplemental information, is approved...

  7. 10 CFR 35.8 - Information collection requirements: OMB approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Information collection requirements: OMB approval. 35.8 Section 35.8 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information..., including NRC Form 313A, which licensees may use to provide supplemental information, is approved...

  8. 10 CFR 35.8 - Information collection requirements: OMB approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Information collection requirements: OMB approval. 35.8 Section 35.8 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information..., including NRC Form 313A, which licensees may use to provide supplemental information, is approved...

  9. 10 CFR 35.8 - Information collection requirements: OMB approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Information collection requirements: OMB approval. 35.8 Section 35.8 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information..., including NRC Form 313A, which licensees may use to provide supplemental information, is approved...

  10. 10 CFR 35.8 - Information collection requirements: OMB approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Information collection requirements: OMB approval. 35.8 Section 35.8 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information..., including NRC Form 313A, which licensees may use to provide supplemental information, is approved...

  11. 5 CFR 7601.102 - Prior approval of outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ARCHIVES AND RECORDS ADMINISTRATION... obtained from the NARA designated agency ethics official. (b) Standard of approval. Approval shall be... employment. For purposes of this section, employment means any form of non-Federal employment or business...

  12. 5 CFR 7101.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... 7101.102 Section 7101.102 Administrative Personnel NATIONAL LABOR RELATIONS BOARD SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL LABOR RELATIONS BOARD § 7101.102 Prior approval... outside employment, an employee must obtain written approval: (1) From the Board of General Counsel to...

  13. Efficacy of Ascorbic Acid (Vitamin C) and/N-Acetylcysteine (NAC) Supplementation on Nutritional and Antioxidant Status of Male Chronic Obstructive Pulmonary Disease (COPD) Patients.

    PubMed

    Pirabbasi, Elham; Shahar, Suzana; Manaf, Zahara Abdul; Rajab, Nor Fadilah; Manap, Roslina Abdul

    2016-01-01

    Antioxidant therapy has a potential to be introduced as therapeutic modality for chronic obstructive pulmonary disease (COPD) patients. This study aimed to determine the effect of antioxidant supplementation [ascorbic acid and N-Acetylcysteine (NAC)] on nutritional and antioxidant status in male COPD patients. A parallel and single blind randomised controlled clinical trial (RCT) was conducted at two medical centers in Kuala Lumpur, Malaysia. Seventy-nine subjects were recruited and randomly divided into four trial arms (i.e., NAC, vitamin C, NAC+vitamin C and control groups) for six mo. The primary outcome was changes in body mass index by estimating power of 90% and significance level of p<0.05. Repeated Measure ANOVA showed that there was a significant interaction effect on BMI (p=0.046) and carbohydrate intake (p=0.030), especially in the NAC group. Plasma glutathione (GSH) increased significantly in all intervention groups, especially in vitamin C (p=0.005). A single supplementation of NAC or vitamin C improved nutritional and antioxidant status of subjects.

  14. The Effect of Probiotic Plus Prebiotic Supplementation on the Tolerance and Efficacy of Helicobacter Pylori Eradication Quadruple Therapy: a Randomized Prospective Double Blind Controlled Trial

    PubMed Central

    Shafaghi, Afshin; Pourkazemi, Aydin; Khosravani, Mohsen; Fakhrie Asl, Saba; Amir Maafi, Alireza; Atrkar Roshan, Zahra; Abaspour Rahimabad, Jafar

    2016-01-01

    BACKGROUND Standard anti-Helicobacter pylori (H. pylori) treatment fails in the eradication of the organism in almost 10-35% of the patients and has different side effects. Recent studies have proposed that probiotic supplementations with or without prebiotic may improve the eradication rate and diminish the side effects, although it is still a controversial issue. We aimed to investigate the effect of probiotic with prebiotic supplementation on the eradication rate and side effects of anti H. pylori quadruple therapy. METHODS 76 patients with a positive biopsy specimen for H. pylori were enrolled. They were randomized to receive quadruple therapy of bismuth, clarithromycin, amoxicillin, and omeprazole for 14 days and also the synbiotic or the placebo. We asked them to answer study questionnaires at the beginning and during the treatment. Finally, urea breath test was done 8 weeks after the treatment. RESULTS The eradication rate was significantly better in the synbiotic group by intention-to-treat analysis (p<0.05). Treatment side effects such as diarrhea, nausea, vomiting, epigastric pain, flatulence, constipation, and taste abnormality were similar in both groups but anorexia was significantly better in the synbiotic group (p <0.05). CONCLUSION The eradication rate was significantly better in the synbiotic group by intention-to-treat analysis (p<0.05). Treatment side effects such as diarrhea, nausea, vomiting, epigastric pain, flatulence, but could improve the eradication by augmenting the treatment tolerance and compliance. PMID:27698967

  15. The regulation of dietary supplements.

    PubMed

    Larsen, Larissa L; Berry, Judith A

    2003-09-01

    To discuss the regulatory history of dietary supplements, define the term dietary supplement, clarify ingredient and nutrition information labeling, and discuss safety issues and implications for practice. Review of primary and secondary sources, including both Internet sites and journal articles. In the United States, 6 out of every 10 people use dietary supplements. For decades, the Food and Drug Administration (FDA) protected the public from mislabeled and unsafe products by regulating as foods those dietary supplements that included only essential nutrients. The Nutrition Labeling and Education Act of 1990 included herbs as dietary supplements. When the Dietary Supplement and Health and Education Act (DSHEA) of 1994 was passed, the FDA lost its regulatory power. The DSHEA expanded the definition of dietary supplements beyond essential nutrients. Dietary supplements are no longer considered food additives, which makes them exempt from prescreening or any safety and efficacy studies before they are released to the public. Under the DSHEA, the FDA may take action if a product poses a direct health threat and only after adverse health effects have already occurred. A good understanding of the regulatory procedures for dietary supplements will aid nurse practitioners (NPs) in patient education regarding these products. Patients should be advised to choose supplements that are made by nationally known food and drug manufacturers that belong to trade groups. NPs and patients can contact the manufacturer directly and can access government Internet sites for more product information.

  16. Efficacy of IEEE 802.16 Based Radio-WAN (Wide Are Networks) in Supplementing Satellite Communications in an Intra-Battlegroup and Amphibious Tactical Network

    DTIC Science & Technology

    2007-09-01

    rely on satellite communications. 4 B. OBJECTIVES The primary objective of this research is to demonstrate the efficacy of wireless networks based...during mission planning and actual operations. While allowing commanders to collaborate with sites thousands of miles apart, VTC transmissions also...data that must be continuously transferred to large and small units in both unicast and multicast transmissions will increase beyond our current SATCOM

  17. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary suspension of approval of a PMA. (a) Scope. (1) This section describes the procedures that FDA will follow in... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an...

  18. Marketing Approval of Ethical Kampo Medicines.

    PubMed

    Hakamatsuka, Takashi

    2017-01-01

     Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

  19. 78 FR 44092 - Agency Information Collection Activities; Proposed Collection; Comment Request: Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... Food and Nutrition Service Agency Information Collection Activities; Proposed Collection; Comment Request: Supplemental Nutrition Assistance Program: State Agency Options AGENCY: Food and Nutrition... is a revision ] of the currently approved burden for the Supplemental Nutrition Assistance Program...

  20. 76 FR 33027 - Agency Information Collection (Supplemental Income Questionnaire (For Philippine Claims Only...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-07

    ... AFFAIRS Agency Information Collection (Supplemental Income Questionnaire (For Philippine Claims Only.... 2900-0668.'' SUPPLEMENTARY INFORMATION: Title: Supplemental Income Questionnaire (For Philippine Claims... approved collection. Abstract: Claimants residing in the Philippines complete VA Form 21-0784 to report...

  1. 76 FR 35424 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... Regulation Supplement; Acquisition of Information Technology AGENCY: Defense Acquisition Regulations System... technology. The Office of Management and Budget (OMB) has approved this information collection requirement... Supplement (DFARS) Part 239, Acquisition of Information Technology, and the associated clauses at DFARS...

  2. Efficacy of an herbal dietary supplement (Smooth Move) in the management of constipation in nursing home residents: A randomized, double-blind, placebo-controlled study.

    PubMed

    Bub, Sam; Brinckmann, Josef; Cicconetti, Greg; Valentine, Barbara

    2006-11-01

    To investigate the efficacy and cost effectiveness of an herbal tea, Smooth Move, in nursing home residents with chronic constipation. Double-blind, placebo-controlled, 2-armed, parallel-group clinical trial. A 483-bed nursing home in Allentown, Pennsylvania, operated by Lehigh County Government. A total of 86 nursing home residents with chronic constipation. Participants (n = 86) were randomly assigned to receive Smooth Move (n = 42) or a placebo (n = 44), once daily, in addition to standard treatment for chronic constipation. The study period was 28 days. The primary efficacy parameter was the difference in total number of bowel movements. Secondary parameters included the difference in average number of standard treatment doses dispensed, and the difference in total medication costs. Compared to placebo, in the intention to treat (ITT analysis) there was a statistically significant increase in the number of bowel movements in the Smooth Move group. The Smooth Move group (n = 42) compared with the placebo group (n = 44) experienced an average of 4.14 more bowel movements during the 28-day study period versus the 28-day pre-study period (P = .017). Smooth Move herbal tea, when added to the standard treatment regimen for nursing home residents with chronic constipation, increased the average number of bowel movements compared to the addition of a placebo tea.

  3. Dietary Supplements

    MedlinePlus

    ... other products. They can come as pills, capsules, powders, drinks, and energy bars. Supplements do not have to go through the testing that drugs do. Some supplements can play an important role in health. For example, calcium and vitamin D are important for keeping bones ...

  4. Effect of vitamin D supplementation on inflammation: protocol for a systematic review.

    PubMed

    Mousa, Aya; Misso, Marie; Teede, Helena; Scragg, Robert; de Courten, Barbora

    2016-04-05

    The extraskeletal role of vitamin D is being increasingly recognised. This has important clinical implications, as vitamin D deficiency has reached epidemic proportions worldwide. Vitamin D has proposed anti-inflammatory properties, yet the role of vitamin D supplementation in reducing inflammation remains largely unknown. The purpose of this review is to investigate the impact of vitamin D supplementation on inflammation, and to identify relevant knowledge gaps in the field. Medline, CINAHL, EMBASE and All EBM will be systematically searched for randomised controlled trials (RCTs) and systematic reviews of RCTs, comparing vitamin D supplementation with placebo, usual care or other pharmacological or non-pharmacological interventions. One reviewer will assess articles for eligibility according to prespecified selection criteria, after which 2 independent reviewers will perform data extraction and quality appraisal. Meta-analyses will be conducted where appropriate. Formal ethical approval is not required as no primary data is collected. This systematic review will identify potential clinical implications of vitamin D deficiency and supplementation, and will be disseminated through a peer-reviewed publication and at conference meetings, to inform future research on the efficacy of vitamin D supplementation for inflammation and inflammatory diseases. CRD42016037104. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  5. Safety and Efficacy of Banaba-Moringa oleifera-Green Coffee Bean Extracts and Vitamin D3 in a Sustained Release Weight Management Supplement.

    PubMed

    Stohs, Sidney J; Kaats, Gilbert R; Preuss, Harry G

    2016-04-01

    This 60-day, 30-subject pilot study examined a novel combination of ingredients in a unique sustained release (Carbopol matrix) tablet consumed twice daily. The product was composed of extracts of banaba leaf, green coffee bean, and Moringa oleifera leaf and vitamin D3. Safety was assessed using a 45-measurement blood chemistry panel, an 86-item self-reported Quality of Life Inventory, bone mineral density, and cardiovascular changes. Efficacy was assessed by calculating a body composition improvement index (BCI) based on changes in dual energy X-ray absorptiometry measured fat mass (FM) and fat-free mass (FFM) as well as between the study group (SG) and a historical placebo group. No changes occurred in any blood chemistry measurements. Positive changes were found in the Quality of Life (QOL) inventory composite scores. No adverse effects were observed. Decreases occurred in FM (p = 0.004) and increases in FFM (p = 0.009). Relative to the historical placebo group, the SG lost more FM (p < 0.0001), gained more FFM (p = <0.0001), and had a negative BCI of -2.7 lb. compared with a positive BCI in the SG of 3.4 lb., a 6.1 discordance (p = 0.0009). The data support the safety and efficacy of this unique product and demonstrate importance of using changes in body composition versus scale weight and BMI. © 2016 The Authors Phytotherapy Research Published by John Wiley & Sons Ltd.

  6. Safety and Efficacy of Banaba–Moringa oleifera–Green Coffee Bean Extracts and Vitamin D3 in a Sustained Release Weight Management Supplement

    PubMed Central

    Kaats, Gilbert R.; Preuss, Harry G.

    2016-01-01

    This 60‐day, 30‐subject pilot study examined a novel combination of ingredients in a unique sustained release (Carbopol matrix) tablet consumed twice daily. The product was composed of extracts of banaba leaf, green coffee bean, and Moringa oleifera leaf and vitamin D3. Safety was assessed using a 45‐measurement blood chemistry panel, an 86‐item self‐reported Quality of Life Inventory, bone mineral density, and cardiovascular changes. Efficacy was assessed by calculating a body composition improvement index (BCI) based on changes in dual energy X‐ray absorptiometry measured fat mass (FM) and fat‐free mass (FFM) as well as between the study group (SG) and a historical placebo group. No changes occurred in any blood chemistry measurements. Positive changes were found in the Quality of Life (QOL) inventory composite scores. No adverse effects were observed. Decreases occurred in FM (p = 0.004) and increases in FFM (p = 0.009). Relative to the historical placebo group, the SG lost more FM (p < 0.0001), gained more FFM (p = <0.0001), and had a negative BCI of −2.7 lb. compared with a positive BCI in the SG of 3.4 lb., a 6.1 discordance (p = 0.0009). The data support the safety and efficacy of this unique product and demonstrate importance of using changes in body composition versus scale weight and BMI. © 2016 The Authors Phytotherapy Research Published by John Wiley & Sons Ltd PMID:26871553

  7. Efficacy of Cistanche Tubulosa and Laminaria Japonica Extracts (MK-R7) Supplement in Preventing Patterned Hair Loss and Promoting Scalp Health

    PubMed Central

    Seok, Joon; Kim, Tae Su; Kwon, Hyun Jung; Lee, Sung Pyo; Kang, Myung Hwa; Kim, Myeung Nam

    2015-01-01

    Cistanche tubulosa and Laminaria japonica have been reported to have anti-oxidative, anticoagulant, anti-cancer and anti-inflammatory properties. They are expected to be a promising candidates for promoting hair growth and treating dandruff and scalp inflammation as a consequence. In this double-blinded, placebo-controlled clinical trial, we investigated the efficacy of Cistanche tubulosa extract and Laminaria japonica extract complex (MK-R7) in promoting hair health in patients with mild to moderate patterned hair loss. Using phototrichogram (Folliscope 4.0, LeadM, Seoul, Korea), we compared the density and diameter of hairs in patients receiving a placebo or Cistanche tubulosa extract and Laminaria japonica extract complex (MK-R7) at baseline, 8 and 16 weeks of the study. In order to determine the efficacy of treatment on dandruff and scalp inflammation, investigator's assessment score and patient's subjective score were also performed. We found a statistically significant increase in the hair density of the test group (n = 45, MK-R7 400 mg) after 16 weeks of consuming the MK-R7 (test group: 23.29 n/cm2 ± 24.26, control: 10.35 n/cm2 ± 20.08, p < 0.05). In addition, we found a statistically significant increase in hair diameter in the test group compared to control group at week 16 (test group: 0.018 mm ± 0.015, control: 0.003 mm ± 0.013, p < 0.05). There were also significant outcomes regarding the investigator's visual assessment and patient's subjective score of dandruff and scalp inflammation in the test group compared to those in control group. Based on the results of this clinical study, we conclude that Cistanche tubulosa extract and Laminaria japonica extract complex (MK-R7) are promising substances for promoting health of the scalp and hair. PMID:25954733

  8. Vortioxetine for major depressive disorder: a systematic review of the efficacy and safety profile for this newly approved antidepressant - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed?

    PubMed

    Citrome, L

    2014-01-01

    To describe the efficacy and safety of vortioxetine for the treatment of major depressive disorder (MDD). The pivotal registration trials were accessed by querying http://www.ncbi.nlm.nih.gov/pubmed/, http://www.clinicaltrialsregister.eu and http://www.clinicaltrials.gov for the search terms 'vortioxetine' and 'Lu AA21004', and by obtaining posters presented at congresses. Product labelling provided additional information. All available clinical reports of studies were identified. Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the available study reports and other sources of information. Vortioxetine is a multi-modal antidepressant that functions as a human 5-HT3A and 5-HT7 receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist, and inhibitor of the serotonin transporter. The recommended dose range is 5-20 mg/day. Approval for the treatment of MDD was based on a clinical development programme that included six positive 6-8 week studies, including one study in elderly people, and one positive maintenance study in adults. In the informative short-term studies in non-elderly patients, NNT for response with vortioxetine vs. placebo was 7 (95% CI 6-9), and NNT for remission vs. placebo was 11 (95% CI 8-17). NNH for discontinuation because of an adverse event (AE) was 36 (95% CI 24-70). The most commonly encountered AEs (incidence ≥ 5% and at least twice the rate of placebo) as identified in product labelling were nausea, constipation and vomiting, with NNH values vs. placebo of 6 (95% CI 6-7), 64 (95% CI 37-240), and 28 (95% CI 23-38), respectively. Changes in weight were not clinically relevant. Vortioxetine represents another option for the treatment of MDD. Vortioxetine appears to have a favourable weight-gain profile. Additional information regarding the time course of response/remission and for the commonly occurring

  9. The efficacy of vitamin C supplementation on reducing total serum cholesterol in human subjects: a review and analysis of 51 experimental trials

    PubMed Central

    McRae, Marc P.

    2006-01-01

    Abstract Objective Observational studies in humans have shown an inverse relationship between plasma vitamin C concentration and total serum cholesterol. However, experimental studies have shown inconsistent results regarding the ability of vitamin C to reduce total serum cholesterol. Methods Published reports of trials studying the effects of vitamin C on serum lipids were identified by a search of Medline from 1966 to 2004. Data from 51 experimental studies comprising of 1666 pooled subjects were selected for analysis. Results A very strong negative association was observed between baseline total serum cholesterol and the percent change in cholesterol (r = −0.585, p<0.001). When subjects were divided into 4 groups based on their baseline total serum cholesterol levels, the following weighted mean percent changes in cholesterol from baseline were observed: normal cholesterol (<199mg/dl): 0.91±6.8% (n=508); borderline high cholesterol (200–239mg/dl): 3.90±5.78% (n=605); high cholesterol (240–279mg/dl): 11.40±7.96% (n=300); severe cholesterol (>280mg/dl): 14.30±8.36% (n=253). A significant inverse relationship was found between the baseline plasma vitamin C concentrations and mean percent change in total cholesterol from baseline (r = −0.500, p<0.005). It was also observed that the high and severe baseline cholesterol groups possessed lower baseline plasma vitamin C concentrations than those in the normal cholesterol groups (0.79 and 0.55 versus 1.24 mg/dl respectively). Conclusion This finding strengthens the hypothesis that the cholesterol lowering and cardio-protective benefit of vitamin C supplementation may be in its ability to elevate plasma vitamin C concentrations in those patients who initially possess lower than normal vitamin C plasma concentrations. PMID:19674666

  10. Tips for Older Dietary Supplement Users

    MedlinePlus

    ... and Efficacy of Dietary Supplements ? What is FDA's Responsibility ? What if I Have had a Reaction to ... from consumers using their products What is FDA's Responsibility? FDA has the responsibility to take action against ...

  11. Efficacy of Resveratrol Supplementation against Non-Alcoholic Fatty Liver Disease: A Meta-Analysis of Placebo-Controlled Clinical Trials

    PubMed Central

    Fang, Jianguo; Wang, Wenqing; He, Pei; Lei, Jiahui; Wang, Chunxu

    2016-01-01

    Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease with rising prevalence. Increasing evidence has demonstrated that resveratrol, a dietary phytochemical, is capable of attenuating NAFLD development and progression; however, results from clinical studies are inconsistent and inconclusive. Here, we conducted a meta-analysis to evaluate the efficacy of resveratrol on NAFLD, using several parameters to provide new insights for clinical application. We systematically searched EMBASE, PubMed, Science Citation Index, Elsevier, and Cochrane Library databases for studies published up to date (July 2016), in English, to identify and screen eligible, relevant studies. Either a fixed-effect model or random model was used to estimate mean difference (MD) and 95% confidence intervals (CIs) for the effect of resveratrol on NAFLD. Four randomized, double-blinded, placebo-controlled trials involving 156 patients were included in the meta-analysis. Levels of low-density lipoprotein (MD = 0.47, 95% CI: 0.21, 0.74, P < 0.05) and total cholesterol (MD = 0.49, 95% CI: 0.18, 0.80, P < 0.05) were higher in the resveratrol treatment groups than in placebo control groups, whereas other parameters were not altered. Overall, this study indicates that resveratrol treatment has negligible effects on attenuating NAFLD, given the small improvement in NAFLD features. More high-quality clinical trials of resveratrol for NAFLD are required to confirm these results. PMID:27560482

  12. Nepali Supplements.

    ERIC Educational Resources Information Center

    Peace Corps, Washington, DC.

    This volume is intended as a supplement to Nepali language instruction. It contains songs, numerals, dialogues in Devanagari script, a Nepali-English, English-Nepali glossary, and an English-Nepali surveyor technical glossary. (AM)

  13. Calcium supplements

    MedlinePlus

    ... TYPES OF CALCIUM SUPPLEMENTS Forms of calcium include: Calcium carbonate: Over-the-counter (OTC) antacid products, such as Tums and Rolaids, contain calcium carbonate. These sources of calcium do not cost much. ...

  14. Dietary Supplements and Sports Performance: Herbals

    PubMed Central

    Williams, Melvin

    2006-01-01

    This is the fourth in a series of six articles to discuss the major classes of dietary supplements (vitamins; minerals; amino acids; herbs or botanicals; metabolites, constituents/extracts, or combinations). The major focus is on efficacy of such dietary supplements to enhance exercise or sport performance. PMID:18500959

  15. Creatine supplementation.

    PubMed

    Hall, Matthew; Trojian, Thomas H

    2013-01-01

    Creatine monohydrate is a dietary supplement that increases muscle performance in short-duration, high-intensity resistance exercises, which rely on the phosphocreatine shuttle for adenosine triphosphate. The effective dosing for creatine supplementation includes loading with 0.3 g·kg·d for 5 to 7 days, followed by maintenance dosing at 0.03 g·kg·d most commonly for 4 to 6 wk. However loading doses are not necessary to increase the intramuscular stores of creatine. Creatine monohydrate is the most studied; other forms such as creatine ethyl ester have not shown added benefits. Creatine is a relatively safe supplement with few adverse effects reported. The most common adverse effect is transient water retention in the early stages of supplementation. When combined with other supplements or taken at higher than recommended doses for several months, there have been cases of liver and renal complications with creatine. Further studies are needed to evaluate the remote and potential future adverse effects from prolonged creatine supplementation.

  16. A randomized controlled study of the efficacy of six-month supplementation with concentrated fish oil rich in omega-3 polyunsaturated fatty acids in first episode schizophrenia.

    PubMed

    Pawełczyk, Tomasz; Grancow-Grabka, Marta; Kotlicka-Antczak, Magdalena; Trafalska, Elżbieta; Pawełczyk, Agnieszka

    2016-02-01

    Short-term clinical trials of omega-3 polyunsaturated fatty acids (n-3 PUFA) as add-on therapy in patients with schizophrenia revealed mixed results. The majority of these studies used an 8- to 12-week intervention based on ethyl-eicosapentaenoic acid. A randomized placebo-controlled trial was designed to compare the efficacy of 26-week intervention, composed of either 2.2 g/day of n-3 PUFA, or olive oil placebo, with regard to symptom severity in first-episode schizophrenia patients. Seventy-one patients (aged 16-35) were enrolled in the study and randomly assigned to the study arms. The primary outcome measure of the clinical evaluation was schizophrenia symptom severity change measured by the Positive and Negative Syndrome Scale (PANSS). Mixed models repeated measures analysis revealed significant differences between the study arms regarding total PANSS score change favouring n-3 PUFA (p = 0.016; effect size (ES) = 0.29). A fifty-percent improvement in symptom severity was achieved significantly more frequently in the n-3 PUFA group than in the placebo group (69.4 vs 40.0%; p = 0.017). N-3 PUFA intervention was also associated with an improvement in general psychopathology, measured by means of PANSS (p = 0.009; ES = 0.32), depressive symptoms (p = 0.006; ES = 0.34), the level of functioning (p = 0.01; ES = 0.31) and clinical global impression (p = 0.046; ES = 0.29). The findings suggest that 6-month intervention with n-3 PUFA may be a valuable add-on therapy able to decrease the intensity of symptoms and improve the level of functioning in first-episode schizophrenia patients.

  17. The efficacy of long-term conjugated linoleic acid (CLA) supplementation on body composition in overweight and obese individuals: a systematic review and meta-analysis of randomized clinical trials.

    PubMed

    Onakpoya, Igho J; Posadzki, Paul P; Watson, Leala K; Davies, Lucy A; Ernst, Edzard

    2012-03-01

    Numerous supplements containing conjugated linoleic acid (CLA) are presently being promoted for body weight reduction. The aim of this systematic review is to evaluate the evidence for or against the long-term efficacy of CLA. Electronic searches were conducted to identify relevant randomized clinical trials (RCTs). No restrictions in age, time, or language were imposed. Studies had to be at least 6 months in duration. Three reviewers independently determined the eligibility of studies. Two reviewers independently extracted data and assessed the reporting quality of all RCTs. Fifteen RCTs were identified, and seven were included. Four of the included RCTs had serious flaws in the reporting of their methodology. A meta-analysis revealed a statistically significant difference in weight loss favouring CLA over placebo (mean difference: -0.70 kg; 95% confidence interval: -1.09, -0.32). Our meta-analysis also revealed a small significant difference in fat loss favouring CLA over placebo (MD: -1.33 kg; 95% CI: -1.79, -0.86; I (2) = 54%). The magnitude of these effects is small, and the clinical relevance is uncertain. Adverse events included constipation, diarrhea, and soft stools. The evidence from RCTs does not convincingly show that CLA intake generates any clinically relevant effects on body composition on the long term.

  18. Influence of the dietary supplement health and education act on consumer beliefs about the safety and effectiveness of dietary supplements.

    PubMed

    Dodge, Tonya; Litt, Dana; Kaufman, Annette

    2011-03-01

    The authors conducted two studies to examine the influence of the U.S. Dietary Supplement Health and Education Act (DSHEA) on consumer beliefs about the safety and effectiveness of dietary supplements. Study 1 manipulated information about Food and Drug Administration (FDA) approval in the context of a dietary supplement designed to improve immune system functioning. Study 2 tested the effect of an educational intervention designed to improve knowledge about the DSHEA. Results of Study 1 highlighted deficits in consumer knowledge about FDA regulation of dietary supplements. Results also showed that information about FDA approval failed to have a statistically significant effect on beliefs about safety or effectiveness of the dietary supplement. Results of Study 2 showed that participants who were educated about the regulation of dietary supplements under the DSHEA rated dietary supplements as less safe and less effective than did participants in the control condition. The authors discuss the implications for consumers in the United States and for public policy.

  19. Efficacy of a supplemental candy coproduct as an alternative carbohydrate source to lactose on growth performance of newly weaned pigs in a commercial farm condition.

    PubMed

    Guo, J Y; Phillips, C E; Coffey, M T; Kim, S W

    2015-11-01

    The experiment investigated the effects of a supplemental candy coproduct (Chocolate Candy Feed [CCF]; International Ingredient Corp., St. Louis, MO), an alternative carbohydrate source to dietary lactose, on growth performance and on health status of nursery pigs. Crossbred pigs ( = 1,408; 21 d of age and 7.1 ± 0.3 kg BW; Smithfield Premium Genetics, Rose Hill, NC) were randomly assigned to 4 treatments (16 pens/treatment and 22 pigs/pen) in a randomized complete block design: 0, 15, 30, and 45% of lactose replaced by CCF based on equal amounts of total sugars. The experimental period was divided into 3 phases: phase I (1.8 kg diet/pig for 11 ± 1 d), phase II (6.8 kg diet/pig for 17 ± 2 d), and phase III (until 49 d after weaning). Pigs received a common phase III diet. The levels of lactose, supplied by whey permeate (79.3 ± 0.8% lactose), were 20, 8, and 0% in phase I, II, and III, respectively. All experimental diets contained the same levels of essential AA and energy (ME) for each phase. Fecal scores were observed on d 5, 7, and 9 after weaning. Blood samples were taken at the end of phase I and II to measure blood urea N. The duration of phase I tended to linearly decrease ( = 0.063) with increasing CCF. In phase I, the ADFI increased ( < 0.05) with increasing CCF whereas ADG and G:F did not change. In phase II, the duration and ADFI did not change whereas ADG linearly decreased ( < 0.05) with increasing CCF. However, the G:F was not changed as CCF increased. During phase I and II together, the duration was linearly decreased ( < 0.05) as CCF increased, whereas no difference in growth performance was observed. Overall, ADFI, ADG, and G:F were not affected by replacing whey permeate with CCF in diets, indicating no adverse effects of a candy coproduct as a carbohydrate substitute to lactose on growth performance of nursery pigs. Blood urea N did not change in phase I but tended to linearly increase ( = 0.088) in phase II as CCF increased. There were no

  20. Redfield Energy Approval

    EPA Pesticide Factsheets

    This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-This October 27, 2016 letter from EPA approves the petition from Redfield Energy, LLC, regarding non-grandfathered ethanol produced

  1. Biosimilars approval process.

    PubMed

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

    For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier.

  2. Supplemental Educational Services: An Action Science Research Study of Achieving State Standards for Provider Effectiveness

    ERIC Educational Resources Information Center

    McClintock, Cynthia Collette

    2012-01-01

    Supplemental educational services are designed to contribute tremendous support to local school districts and communities through state-approved provider programs. The state, however, prior to approving supplemental educational services provider programs, must utilize all available resources to assist in the process of screening and approving…

  3. 25 CFR 170.925 - Is ERFO funding supplemental to IRR Program funding?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 25 Indians 1 2011-04-01 2011-04-01 false Is ERFO funding supplemental to IRR Program funding? 170... IRR Program funding? Yes. If ERFO funds are approved and available, they can be used to supplement IRR construction and maintenance funds for FHWA-approved repairs. If IRR construction or maintenance funds are...

  4. 25 CFR 170.925 - Is ERFO funding supplemental to IRR Program funding?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Is ERFO funding supplemental to IRR Program funding? 170... IRR Program funding? Yes. If ERFO funds are approved and available, they can be used to supplement IRR construction and maintenance funds for FHWA-approved repairs. If IRR construction or maintenance funds are...

  5. Dietary supplements in weight reduction.

    PubMed

    Dwyer, Johanna T; Allison, David B; Coates, Paul M

    2005-05-01

    We summarize evidence on the role of dietary supplements in weight reduction, with particular attention to their safety and benefits. Dietary supplements are used for two purposes in weight reduction: (a) providing nutrients that may be inadequate in calorie-restricted diets and (b) for their potential benefits in stimulating weight loss. The goal in planning weight-reduction diets is that total intake from food and supplements should meet recommended dietary allowance/adequate intake levels without greatly exceeding them for all nutrients, except energy. If nutrient amounts from food sources in the reducing diet fall short, dietary supplements containing a single nutrient/element or a multivitamin-mineral combination may be helpful. On hypocaloric diets, the addition of dietary supplements providing nutrients at a level equal to or below recommended dietary allowance/adequate intake levels or 100% daily value, as stated in a supplement's facts box on the label, may help dieters to achieve nutrient adequacy and maintain electrolyte balance while avoiding the risk of excessive nutrient intakes. Many botanical and other types of dietary supplements are purported to be useful for stimulating or enhancing weight loss. Evidence of their efficacy in stimulating weight loss is inconclusive at present. Although there are few examples of safety concerns related to products that are legal and on the market for this purpose, there is also a paucity of evidence on safety for this intended use. Ephedra and ephedrine-containing supplements, with or without caffeine, have been singled out in recent alerts from the Food and Drug Administration because of safety concerns, and use of products containing these substances cannot be recommended. Dietitians should periodically check the Food and Drug Administration Web site ( www.cfsan.fda.gov ) for updates and warnings and alert patients/clients to safety concerns. Dietetics professionals should also consult authoritative sources for

  6. Weight Loss Nutritional Supplements

    NASA Astrophysics Data System (ADS)

    Eckerson, Joan M.

    Obesity has reached what may be considered epidemic proportions in the United States, not only for adults but for children. Because of the medical implications and health care costs associated with obesity, as well as the negative social and psychological impacts, many individuals turn to nonprescription nutritional weight loss supplements hoping for a quick fix, and the weight loss industry has responded by offering a variety of products that generates billions of dollars each year in sales. Most nutritional weight loss supplements are purported to work by increasing energy expenditure, modulating carbohydrate or fat metabolism, increasing satiety, inducing diuresis, or blocking fat absorption. To review the literally hundreds of nutritional weight loss supplements available on the market today is well beyond the scope of this chapter. Therefore, several of the most commonly used supplements were selected for critical review, and practical recommendations are provided based on the findings of well controlled, randomized clinical trials that examined their efficacy. In most cases, the nutritional supplements reviewed either elicited no meaningful effect or resulted in changes in body weight and composition that are similar to what occurs through a restricted diet and exercise program. Although there is some evidence to suggest that herbal forms of ephedrine, such as ma huang, combined with caffeine or caffeine and aspirin (i.e., ECA stack) is effective for inducing moderate weight loss in overweight adults, because of the recent ban on ephedra manufacturers must now use ephedra-free ingredients, such as bitter orange, which do not appear to be as effective. The dietary fiber, glucomannan, also appears to hold some promise as a possible treatment for weight loss, but other related forms of dietary fiber, including guar gum and psyllium, are ineffective.

  7. Common dietary supplements for weight loss.

    PubMed

    Saper, Robert B; Eisenberg, David M; Phillips, Russell S

    2004-11-01

    Over-the-counter dietary supplements to treat obesity appeal to many patients who desire a "magic bullet" for weight loss. Asking overweight patients about their use of weight-loss supplements and understanding the evidence for the efficacy, safety, and quality of these supplements are critical when counseling patients regarding weight loss. A schema for whether physicians should recommend, caution, or discourage use of a particular weight-loss supplement is presented in this article. More than 50 individual dietary supplements and more than 125 commercial combination products are available for weight loss. Currently, no weight-loss supplements meet criteria for recommended use. Although evidence of modest weight loss secondary to ephedra-caffeine ingestion exists, potentially serious adverse effects have led the U.S. Food and Drug Administration to ban the sale of these products. Chromium is a popular weight-loss supplement, but its efficacy and long-term safety are uncertain. Guar gum and chitosan appear to be ineffective; therefore, use of these products should be discouraged. Because of insufficient or conflicting evidence regarding the efficacy of conjugated linoleic acid, ginseng, glucomannan, green tea, hydroxycitric acid, L-carnitine, psyllium, pyruvate, and St. John's wort in weight loss, physicians should caution patients about the use of these supplements and closely monitor those who choose to use these products.

  8. Sports Supplements

    MedlinePlus

    ... For example, teen athletes who use medications like human growth hormone (hGH) that haven't been prescribed for them can have problems with growth, and may develop diabetes and heart problems. Lots of sports organizations have developed policies on sports supplements. The National ...

  9. Biofortified orange maize is as efficacious as a vitamin A supplement in Zambian children even in the presence of high liver reserves of vitamin A: a community-based, randomized placebo-controlled trial.

    PubMed

    Gannon, Bryan; Kaliwile, Chisela; Arscott, Sara A; Schmaelzle, Samantha; Chileshe, Justin; Kalungwana, Ngándwe; Mosonda, Mofu; Pixley, Kevin; Masi, Cassim; Tanumihardjo, Sherry A

    2014-12-01

    Biofortification is a strategy to relieve vitamin A (VA) deficiency. Biofortified maize contains enhanced provitamin A concentrations and has been bioefficacious in animal and small human studies. The study sought to determine changes in total body reserves (TBRs) of vitamin A with consumption of biofortified maize. A randomized, placebo-controlled biofortified maize efficacy trial was conducted in 140 rural Zambian children. The paired (13)C-retinol isotope dilution test, a sensitive biomarker for VA status, was used to measure TBRs before and after a 90-d intervention. Treatments were white maize with placebo oil (VA-), orange maize with placebo (orange), and white maize with VA in oil [400 μg retinol activity equivalents (RAEs) in 214 μL daily] (VA+). In total, 133 children completed the trial and were analyzed for TBRs (n = 44 or 45/group). Change in TBR residuals were not normally distributed (P < 0.0001); median changes (95% CI) were as follows: VA-, 13 (-19, 44) μmol; orange, 84 (21, 146) μmol; and VA+, 98 (24, 171) μmol. Nonparametric analysis showed no statistical difference between VA+ and orange (P = 0.34); both were higher than VA- (P = 0.0034). Median (95% CI) calculated liver reserves at baseline were 1.04 (0.97, 1.12) μmol/g liver, with 59% >1 μmol/g, the subtoxicity cutoff; none were <0.1 μmol/g, the deficiency cutoff. The calculated bioconversion factor was 10.4 μg β-carotene equivalents/1 μg retinol by using the middle 3 quintiles of change in TBRs from each group. Serum retinol did not change in response to intervention (P = 0.16) but was reduced with elevated C-reactive protein (P = 0.0029) and α-1-acid glycoprotein (P = 0.0023) at baseline. β-Carotene from maize was efficacious when consumed as a staple food in this population and could avoid the potential for hypervitaminosis A that was observed with the use of preformed VA from supplementation and fortification. Use of more sensitive methods other than serum retinol alone, such

  10. Safety and efficacy of the nonsystemic chewable complex carbohydrate dietary supplement PAZ320 on postprandial glycemia when added to oral agents or insulin in patients with type 2 diabetes mellitus.

    PubMed

    Trask, Laura E; Kasid, Natasha; Homa, Karen; Chaidarun, Sushela

    2013-01-01

    Our primary objective was to evaluate the effect of the dietary supplement PAZ320 on postprandial glucose excursion. PAZ320 is derived from glucomannan and acts by blocking carbohydrate hydrolyzing enzymes and by binding to ingested polysaccharides. Endpoints included area under the curve during postprandial glucose excursion (gAUC) and adverse reactions. In an open-label, sequential dose-escalation, prospective study, we examined the efficacy and safety of PAZ320 in 24 subjects with type 2 diabetes treated with oral agents and/or insulin. Subjects consumed 75 g jasmine rice alone or with low-dose (8 g) or high-dose (16 g) PAZ320. A real-time blinded continuous glucose monitor (CGM) was used to assess 3-hour postprandial glycemia. We found that 45% of subjects responded to high-dose PAZ320 as evidenced by a decrease in gAUC of 40% compared to baseline in a dose-dependent manner. The effect of PAZ320 does not correlate with duration of diabetes and seems to work regardless of concurrent diabetes medications. The responders had higher postmeal glucose elevation at baseline, while the nonresponders showed no effect or paradoxic glucose response to PAZ320. There was no severe hypoglycemia, and the gastrointestinal side effects were mild. PAZ320 may be useful as an adjunct to decrease postprandial glycemia in type 2 diabetes, although patients should verify its effect on postprandial glucose due to a possible paradoxic response. Its safety profile is reassuring. Further study is required to determine its long-term effects on glycated hemoglobin (HbA1c) and to further define which subpopulation may respond to PAZ320.

  11. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  12. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  13. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  14. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  15. 47 CFR 87.347 - Supplemental eligibility.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Aeronautical Utility Mobile Stations § 87.347 Supplemental eligibility. (a) Aeronautical utility stations may transmit on unicom frequencies only at airports which have a unicom and a part-time or no control tower, an... the airport control tower approves the requested use of the tower or RCO frequency....

  16. 47 CFR 87.347 - Supplemental eligibility.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Aeronautical Utility Mobile Stations § 87.347 Supplemental eligibility. (a) Aeronautical utility stations may transmit on unicom frequencies only at airports which have a unicom and a part-time or no control tower, an... the airport control tower approves the requested use of the tower or RCO frequency....

  17. 21 CFR 812.35 - Supplemental applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... approval of a supplement do not apply in the case of a deviation from the investigational plan to protect... control procedures of § 820.30, preclinical/animal testing, peer reviewed published literature, or other... conclusion that a change does not have a significant impact on the study design or planned statistical...

  18. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... feasible and ethical. Such postmarketing studies would not be feasible until an exigency arises. When such... studies become ethical and feasible. (2) Approval with restrictions to ensure safe use. If FDA concludes...

  19. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... feasible and ethical. Such postmarketing studies would not be feasible until an exigency arises. When such... studies become ethical and feasible. (2) Approval with restrictions to ensure safe use. If FDA concludes...

  20. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... feasible and ethical. Such postmarketing studies would not be feasible until an exigency arises. When such... studies become ethical and feasible. (2) Approval with restrictions to ensure safe use. If FDA concludes...

  1. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... feasible and ethical. Such postmarketing studies would not be feasible until an exigency arises. When such... studies become ethical and feasible. (2) Approval with restrictions to ensure safe use. If FDA concludes...

  2. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... feasible and ethical. Such postmarketing studies would not be feasible until an exigency arises. When such... studies become ethical and feasible. (2) Approval with restrictions to ensure safe use. If FDA concludes...

  3. Specialty Engineering Supplement to IEEE-15288.1

    DTIC Science & Technology

    2015-05-15

    MISSILE SYSTEMS CENTER TAILORING SPECIALTY ENGINEERING SUPPLEMENT TO IEEE -15288.1 APPROVED FOR PUBLIC RELEASE; DISTRIBUTION...IS UNLIMITED 1 Tailoring of IEEE 15288.1: Specialty Engineering Supplement. 1. Intent of this Tailoring Document This tailoring document is...historically deemed valuable to mission assurance/success of high-reliability space systems. This tailoring document supplements IEEE 15288.1-2015 Annex E

  4. 78 FR 17866 - New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ... Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane... Technologies GONABREED (gonadorelin 1. Original approval 522.1073 yes 1. CE \\2\\ Pty. Ltd., unit 4, 476 acetate... South 2. Supplemental Wales 2015, Australia. approval for use with cloprostenol sodium to synchronize...

  5. More New Medication Approvals.

    PubMed

    Turkoski, Beatrice B

    2016-01-01

    In the past year, the Federal Drug Administration (FDA) approved many new drugs for treating a wide variety of patient health problems. In a previous article, examples of approvals for the early part of last year were addressed. In this article, selected new FDA approvals through January 2016 are discussed. Nurses who are knowledgeable and informed about these new drugs will be able to answer patients' questions, clarify misunderstandings, and reduce the potential for medication misadventures.

  6. Trelagliptin: First Global Approval.

    PubMed

    McKeage, Kate

    2015-07-01

    Trelagliptin (Zafatek(®)) is an orally active dipeptidyl peptidase (DPP)-4 inhibitor developed by Takeda and approved in Japan for the treatment of type 2 diabetes mellitus (T2DM). Unlike other approved agents of its class, which are usually administered once daily, trelagliptin can be administered once weekly. Phase II development of trelagliptin was discontinued in the USA and EU, as Takeda considered that the costs associated with obtaining approval in these markets were prohibitive. This article summarizes the milestones in the development of trelagliptin leading to this first approval for T2DM.

  7. Cardiovascular effects of calcium supplements.

    PubMed

    Reid, Ian R

    2013-07-05

    Calcium supplements reduce bone turnover and slow the rate of bone loss. However, few studies have demonstrated reduced fracture incidence with calcium supplements, and meta-analyses show only a 10% decrease in fractures, which is of borderline statistical and clinical significance. Trials in normal older women and in patients with renal impairment suggest that calcium supplements increase the risk of cardiovascular disease. To further assess their safety, we recently conducted a meta-analysis of trials of calcium supplements, and found a 27%-31% increase in risk of myocardial infarction, and a 12%-20% increase in risk of stroke. These findings are robust because they are based on pre-specified analyses of randomized, placebo-controlled trials and are consistent across the trials. Co-administration of vitamin D with calcium does not lessen these adverse effects. The increased cardiovascular risk with calcium supplements is consistent with epidemiological data relating higher circulating calcium concentrations to cardiovascular disease in normal populations. There are several possible pathophysiological mechanisms for these effects, including effects on vascular calcification, vascular cells, blood coagulation and calcium-sensing receptors. Thus, the non-skeletal risks of calcium supplements appear to outweigh any skeletal benefits, and are they appear to be unnecessary for the efficacy of other osteoporosis treatments.

  8. Tyrosine supplementation for phenylketonuria.

    PubMed

    Webster, Diana; Wildgoose, Joanne

    2010-08-04

    Phenylketonuria is an inherited disease for which the main treatment is the dietary restriction of the amino acid phenylalanine. The diet has to be initiated in the neonatal period to prevent or reduce mental handicap. However, the diet is very restrictive and unpalatable and can be difficult to follow. A deficiency of the amino acid tyrosine has been suggested as a cause of some of the neuropsychological problems exhibited in phenylketonuria. Therefore, this review aims to assess the efficacy of tyrosine supplementation for phenylketonuria. To assess the effects of tyrosine supplementation alongside or instead of a phenylalanine-restricted diet for people with phenylketonuria, who commenced on diet at diagnosis and either continued on the diet or relaxed the diet later in life. To assess the evidence that tyrosine supplementation alongside, or instead of a phenylalanine-restricted diet improves intelligence, neuropsychological performance, growth and nutritional status, mortality rate and quality of life. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register which is comprised of references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. Additional studies were identified from handsearches of the Journal of Inherited Metabolic Disease (from inception in 1978 to 1998). The manufacturers of prescribable dietary products used in the treatment of phenylketonuria were also contacted for further references.Date of the most recent search of the Group's Inborn Errors of Metabolism Trials Register: 09 June 2010. All randomised or quasi-randomised trials investigating the use of tyrosine supplementation versus placebo in people with phenylketonuria in addition to, or instead of, a phenylalanine-restricted diet. People treated for maternal phenylketonuria were excluded. Two authors independently assessed the trial eligibility, methodological quality

  9. Tyrosine supplementation for phenylketonuria.

    PubMed

    Webster, Diana; Wildgoose, Joanne

    2013-06-05

    Phenylketonuria is an inherited disease for which the main treatment is the dietary restriction of the amino acid phenylalanine. The diet has to be initiated in the neonatal period to prevent or reduce mental handicap. However, the diet is very restrictive and unpalatable and can be difficult to follow. A deficiency of the amino acid tyrosine has been suggested as a cause of some of the neuropsychological problems exhibited in phenylketonuria. Therefore, this review aims to assess the efficacy of tyrosine supplementation for phenylketonuria. To assess the effects of tyrosine supplementation alongside or instead of a phenylalanine-restricted diet for people with phenylketonuria, who commenced on diet at diagnosis and either continued on the diet or relaxed the diet later in life. To assess the evidence that tyrosine supplementation alongside, or instead of a phenylalanine-restricted diet improves intelligence, neuropsychological performance, growth and nutritional status, mortality rate and quality of life. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register which is comprised of references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. Additional studies were identified from handsearches of the Journal of Inherited Metabolic Disease (from inception in 1978 to 1998). The manufacturers of prescribable dietary products used in the treatment of phenylketonuria were also contacted for further references.Date of the most recent search of the Group's Inborn Errors of Metabolism Trials Register: 28 June 2012. All randomised or quasi-randomised trials investigating the use of tyrosine supplementation versus placebo in people with phenylketonuria in addition to, or instead of, a phenylalanine-restricted diet. People treated for maternal phenylketonuria were excluded. Two authors independently assessed the trial eligibility, methodological quality

  10. 76 FR 34739 - Agency Information Collection Activities: HRIFA Instructions for Form I-485, Supplement C...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

    ... Instructions for Form I-485, Supplement C; Extension of a Currently Approved Information Collection; Comment.../Collection: HRIFA Instructions for Form I- 485, Supplement C. (3) Agency form number, if any, and the... provided on the Form I-485 Supplement C, in combination with the information collected on Form...

  11. 77 FR 59666 - Agency Information Collection Activities; Extension of a Currently Approved Collection; Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-28

    ... of Justice Programs Agency Information Collection Activities; Extension of a Currently Approved Collection; Comments Requested: School Crime Supplement (SCS) to the National Crime Victimization Survey... comments from the public and affected agencies. This proposed information collection was previously...

  12. 42 CFR 422.256 - Review, negotiation, and approval of bids.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... beneficiary premium and supplemental premium. (e) Exception for MSA plans. CMS does not review, negotiate, or approve amounts submitted with respect to MA MSA plans, except to determine that the deductible does not...

  13. 42 CFR 422.256 - Review, negotiation, and approval of bids.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... beneficiary premium and supplemental premium. (e) Exception for MSA plans. CMS does not review, negotiate, or approve amounts submitted with respect to MA MSA plans, except to determine that the deductible does not...

  14. Use of dietary supplements among preschool children in Japan.

    PubMed

    Sato, Yoko; Yamagishi, Azumi; Hashimoto, Yoko; Virgona, Nantiga; Hoshiyama, Yoshiharu; Umegaki, Keizo

    2009-08-01

    This study was conducted to examine the characteristics and use of dietary supplements by preschool children in Japan. A survey was conducted among 2,125 parents of preschool children to discover the status of dietary supplement use and their attitudes towards supplement use by their children. Logistic regression models were used to determine which characteristics predict supplement use in this population. For detailed characterization, child supplement users were also categorized as either the users of vitamins and minerals only or the users of other supplement components. For parents of non-user children, the parent's knowledge and attitudes toward supplements for children were investigated. Fifteen percent of children had used dietary supplements. Two parent-related factors were especially important, the frequency with which they referred to nutritional labels and their own supplement use, which had a significant encouraging effect on their children's supplement use. The parents of child supplement users showed limited awareness of the government system concerning diet and food, placed safety over efficacy, selected products with natural ingredients, and did not seek consultations with professionals. These parents, especially those who were aware of the specially designed supplements for children, exhibited positive responses to supplement use by their children. It is likely that parents' knowledge and attitudes toward dietary supplements and nutrition have a striking effect on their children's use of supplements. Unfortunately, their knowledge at present was less than satisfactory. More accurate information on nutrition, dietary intake and dietary supplements must be disseminated.

  15. Venetoclax Approved for CLL.

    PubMed

    2016-06-01

    Venetoclax, a BCL2 inhibitor, has been approved for patients with chronic lymphocytic leukemia (CLL) who lack part of chromosome 17. The FDA also approved a companion diagnostic, the Vysis CLL FISH probe kit, to detect the 17p deletion in patients' peripheral blood.

  16. Podophyllum hexandrum as a potential botanical supplement for the medical management of nuclear and radiological emergencies (NREs) and free radical-mediated ailments: leads from in vitro/in vivo radioprotective efficacy evaluation.

    PubMed

    Arora, Rajesh; Chawla, Raman; Dhaker, Atlar Singh; Adhikari, Manish; Sharma, Jyoti; Singh, Shikha; Gupta, Damodar; Kumar, Raj; Sharma, Ashok; Sharma, Rakesh K; Tripathi, Rajender P

    2010-03-01

    Management of radiation-induced reactive oxygen/nitrogen species requires a holistic approach to mitigate the deleterious effects of free radicals. Flora of the Himalayas, which prevails under extreme climatic conditions, has been explored for its potential utility to develop radioprotective drugs. The Himalayan high altitude medicinal plant, Podophyllum hexandrum Royle, was selected on the basis of its unique properties, and a novel fractionated nonpolar extract (REC-2003) was prepared and evaluated for radioprotective efficacy, in vitro as well as in vivo. The free radical scavenging activity of REC-2003 was found to be > 75% (20 μg/ml) with maximum superoxide scavenging activity (57.56 ± 1.38%) recorded at 1 mg/ml concentration (tetrazolium-based estimation). More than 30% inhibition of nitric oxide radicals was observed at concentrations > 0.5 mg/ml, while hydroxyl radical scavenging activity (deoxy-D-ribose assay) exhibited a dose-dependent (100-600 μg/ml) increase. Significantly high (90%) protection to human erythrocytes was observed at 75 μg/ml, which was found to be the most optimized dose. Similarly, more than 90% inhibition was observed against lipid peroxidation (evaluated by estimating levels of malondialdehyde). The significant antihemolytic potential of REC-2003 could be attributed to its ability to scavenge free radicals, reduce peroxidative stress on lipid membranes, and render protection to DNA (evaluated using plasmid relaxation assay). All these activities holistically contributed toward the radioprotective ability. REC-2003 (8 mg/kg BW; intraperitoneal (i.p.), -30 min) rendered > 80% total-body protection in Swiss Albino Strain 'A' mice [against lethal radiation (10 Gy)] in a 30-day survival assay. Phytochemical characterization of the constituents of REC-2003 revealed the presence of polyphenolics (flavonoids). The characterized constituents also included the aryl-tetralin lignans like podophyllotoxin, its glycoside, 4'-demethyl derivative

  17. Herbal supplements: Facts and myths--talking to your patients about herbal supplements.

    PubMed

    Messina, Barbara Ann M

    2006-08-01

    The use of herbal supplements in the United States is steadily growing and raises concerns about safety, efficacy, and how they affect safe patient care. The direct health risks associated with herbal supplements include hypertension, prolonged bleeding, and the potential for drug-herb interactions. These potential drug interactions are of particular concern for patients undergoing anesthesia. This article provides a review of literature on the 10 most popular herbal supplements and addresses the herbal supplements' reported use, possible adverse effect(s), patient teaching, possible drug interaction(s), and recommendations regarding discontinuation before surgery.

  18. 5 CFR 6501.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... 6501.102 Section 6501.102 Administrative Personnel NATIONAL ENDOWMENT FOR THE ARTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ENDOWMENT FOR THE ARTS § 6501.102 Prior approval... employee. It includes, but is not limited to personal services such as an officer, director, employee...

  19. 5 CFR 6501.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... 6501.102 Section 6501.102 Administrative Personnel NATIONAL ENDOWMENT FOR THE ARTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ENDOWMENT FOR THE ARTS § 6501.102 Prior approval... employee. It includes, but is not limited to personal services such as an officer, director, employee...

  20. 5 CFR 6501.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... 6501.102 Section 6501.102 Administrative Personnel NATIONAL ENDOWMENT FOR THE ARTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ENDOWMENT FOR THE ARTS § 6501.102 Prior approval... employee. It includes, but is not limited to personal services such as an officer, director, employee...

  1. 5 CFR 6601.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Prior approval for outside employment. 6601.102 Section 6601.102 Administrative Personnel NATIONAL ENDOWMENT FOR THE HUMANITIES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ENDOWMENT FOR THE HUMANITIES § 6601.102 Prior...

  2. 5 CFR 6601.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Prior approval for outside employment. 6601.102 Section 6601.102 Administrative Personnel NATIONAL ENDOWMENT FOR THE HUMANITIES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ENDOWMENT FOR THE HUMANITIES § 6601.102 Prior...

  3. 5 CFR 6501.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Prior approval for outside employment. 6501.102 Section 6501.102 Administrative Personnel NATIONAL ENDOWMENT FOR THE ARTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ENDOWMENT FOR THE ARTS § 6501.102 Prior...

  4. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Prior approval for outside employment. 6401.103 Section 6401.103 Administrative Personnel ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.103 Prior...

  5. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Prior approval for outside employment. 6401.103 Section 6401.103 Administrative Personnel ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.103 Prior...

  6. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Prior approval for outside employment. 6401.103 Section 6401.103 Administrative Personnel ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.103 Prior...

  7. 5 CFR 6401.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Prior approval for outside employment. 6401.103 Section 6401.103 Administrative Personnel ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.103 Prior...

  8. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Prior approval for outside employment. 7801.102 Section 7801.102 Administrative Personnel COMMISSION ON CIVIL RIGHTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE UNITED STATES COMMISSION ON CIVIL RIGHTS § 7801.102 Prior...

  9. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Prior approval for outside employment. 7801.102 Section 7801.102 Administrative Personnel COMMISSION ON CIVIL RIGHTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE UNITED STATES COMMISSION ON CIVIL RIGHTS § 7801.102 Prior...

  10. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Prior approval for outside employment. 7801.102 Section 7801.102 Administrative Personnel COMMISSION ON CIVIL RIGHTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE UNITED STATES COMMISSION ON CIVIL RIGHTS § 7801.102 Prior...

  11. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Prior approval for outside employment. 7801.102 Section 7801.102 Administrative Personnel COMMISSION ON CIVIL RIGHTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE UNITED STATES COMMISSION ON CIVIL RIGHTS § 7801.102 Prior...

  12. 5 CFR 7801.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside employment. 7801.102 Section 7801.102 Administrative Personnel COMMISSION ON CIVIL RIGHTS SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE UNITED STATES COMMISSION ON CIVIL RIGHTS § 7801.102 Prior...

  13. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES §...

  14. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES §...

  15. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES §...

  16. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES §...

  17. 5 CFR 7701.102 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Prior approval for outside employment. 7701.102 Section 7701.102 Administrative Personnel INSTITUTE OF MUSEUM AND LIBRARY SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE INSTITUTE OF MUSEUM AND LIBRARY SERVICES §...

  18. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... approval and approval plates. 18.99 Section 18.99 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... disapproval; letters of approval and approval plates. Upon completion of each inspection conducted in... District Manager who authorized its issuance and send the field approval plate to the applicant. The...

  19. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... approval and approval plates. 18.99 Section 18.99 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... disapproval; letters of approval and approval plates. Upon completion of each inspection conducted in... District Manager who authorized its issuance and send the field approval plate to the applicant. The...

  20. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... approval and approval plates. 18.99 Section 18.99 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... disapproval; letters of approval and approval plates. Upon completion of each inspection conducted in... District Manager who authorized its issuance and send the field approval plate to the applicant. The...

  1. 5 CFR 4501.103 - Prior approval for certain outside activities.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Prior approval for certain outside activities. 4501.103 Section 4501.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OFFICE OF PERSONNEL MANAGEMENT § 4501.103 Prior approval...

  2. 5 CFR 4501.103 - Prior approval for certain outside activities.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Prior approval for certain outside activities. 4501.103 Section 4501.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OFFICE OF PERSONNEL MANAGEMENT § 4501.103 Prior approval...

  3. 5 CFR 4501.103 - Prior approval for certain outside activities.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Prior approval for certain outside activities. 4501.103 Section 4501.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OFFICE OF PERSONNEL MANAGEMENT § 4501.103 Prior approval...

  4. Drugs Approved for Prostate Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Prostate Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Prostate Cancer Abiraterone Acetate Bicalutamide Cabazitaxel Casodex (Bicalutamide) Degarelix Docetaxel ...

  5. Drugs Approved for Thyroid Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) Doxorubicin ...

  6. Drugs Approved for Brain Tumors

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Brain Tumors This page lists cancer drugs approved by ... that are not listed here. Drugs Approved for Brain Tumors Afinitor (Everolimus) Afinitor Disperz (Everolimus) Avastin (Bevacizumab) ...

  7. Evidence for supplemental treatments in androgenetic alopecia.

    PubMed

    Famenini, Shannon; Goh, Carolyn

    2014-07-01

    Currently, topical minoxidil and finasteride are the only treatments that have been FDA approved for the treatment of female pattern hair loss and androgenetic alopecia. Given the incomplete efficacy and sife effect profile of these medications, some patients utilize alternative treatments to help improve this condition. In this review, we illustrate the scientific evidence underlying the efficacy of these alternative approaches, including biotin, caffeine, melatonin, a marine extract, and zinc.

  8. Rare cancer trial design: lessons from FDA approvals.

    PubMed

    Gaddipati, Himabindu; Liu, Ke; Pariser, Anne; Pazdur, Richard

    2012-10-01

    A systematic analysis of clinical trials supporting rare cancer drug approvals may identify concepts and terms that can inform the effective design of prospective clinical trials for rare cancers. In this article, using annual incidence ≤6 of 100,000 individuals to define "rare cancer," we identified clinical trials for rare cancers, supporting U.S. Food and Drug Administration (FDA) drug approvals for rare cancer indications between December 1987 and May 2011. We characterized each selected trial for study design, sample size, primary efficacy endpoints, and statistical comparisons. We also profiled trials with regard to type of submission, review designation, and approval type. Our results indicated that, of 99 trials that supported the approvals of 45 drugs for 68 rare cancer indications, one third of these trials were randomized; 69% of approvals relied on objective response rate as the primary efficacy endpoint; and 63% were based on a single trial. Drugs granted accelerated approval appeared more likely to be associated with postmarketing safety findings, relative to drugs approved under the regular approval. Data collected across clinical trials were robust: Use of different lower incidence rates in analyzing these trials did not have effects on trial characteristics. The absolute number of drug approvals for rare cancer indications increased markedly over time. We concluded that one third of clinical trials supporting drug approvals for rare cancer indications were randomized, affirming the feasibility and value of randomized trial design to evaluate drugs for rare cancers. Postmarketing safety data may relate to trial design and approval type. An operational definition of "rare cancer" can be useful for the analysis of trial data and for the path toward harmonizing the terminology in the area of clinical research on rare cancers.

  9. Canadian and US drug approval times and safety considerations.

    PubMed

    Rawson, Nigel S B; Kaitin, Kenneth I

    2003-10-01

    Approval times of new drugs are frequently longer in Canada than in the US, but it has been argued that reducing approval times might lead to unsafe drugs receiving marketing approval. To compare new drug approval times in Canada and the US over a 10-year period and to relate them to safety discontinuations. Application and approval dates of all new drugs except diagnostic products, new salts, esters, isomers, and dosage forms of already-marketed drugs, as well as combinations containing previously approved substances approved in the US and Canada between January 1992 and December 2001 were obtained from the respective drug regulatory agencies and other sources. Information about drugs discontinued for safety reasons was obtained from the agencies' publications and Web sites and from journal articles. New drug approval times were significantly longer in Canada than in the US. The difference occurs in all drug categories and by review type (priority/standard). However, the proportion of new drugs approved and later discontinued for safety reasons from the Canadian market (2.0%) was just over half that in the US (3.6%). When serious drug safety problems were identified in a timely manner after US approval, the products were not subsequently approved in Canada. Canada avoided potential dangers because its longer approval times provided an opportunity to observe actual market experience in other countries. However, the trade-off is that new drugs, including those for conditions for which current therapy has limited efficacy, take significantly longer to be approved in Canada and, hence, to be available to Canadians.

  10. 77 FR 11452 - Approval and Promulgation of Air Quality Implementation Plans; State of Georgia; Regional Haze...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ...EPA is proposing a limited approval of a revision to the Georgia state implementation plan (SIP) submitted by the State of Georgia through the Georgia Department of Natural Resources, Environmental Protection Division (GA EPD), on February 11, 2010, as supplemented on November 19, 2010, that addresses regional haze for the first implementation period. This SIP revision, as supplemented,......

  11. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Temporary suspension of approval of a PMA. 814.47 Section 814.47 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an...

  12. Oral potassium supplementation in surgical patients.

    PubMed

    Hainsworth, Alison J; Gatenby, Piers A

    2008-08-01

    Hospital inpatients are frequently hypokalaemic. Low plasma potassium levels may cause life threatening complications, such as cardiac arrhythmias. Potassium supplementation may be administered parenterally or enterally. Oral potassium supplements have been associated with oesophageal ulceration, strictures and gastritis. An alternative to potassium salt tablets or solution is dietary modification with potassium rich food stuffs, which has been proven to be a safe and effective method for potassium supplementation. The potassium content of one medium banana is equivalent to a 12 mmol potassium salt tablet. Potassium supplementation by dietary modification has been shown to be equally efficacious to oral potassium salt supplementation and is preferred by the majority of patients. Subsequently, it is our practice to replace potassium using dietary modification, particularly in surgical patients having undergone oesophagogastrectomy or in those with peptic ulcer disease.

  13. Poet Marion Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

  14. Poet Alexandria Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Alexandria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

  15. Poet North Manchester Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

  16. Poet Portland Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves the petition, with modifications, from Poet Biorefining-Portland, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

  17. Drugs Approved for Leukemia

    Cancer.gov

    This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  18. Drugs Approved for Neuroblastoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  19. Drugs Approved for Retinoblastoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  20. Kansas Ethanol Lyons Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Kansas Ethanol, LLC, Lyons facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

  1. Poet Laddonia Approval

    EPA Pesticide Factsheets

    This update Auugust 9, 2016 letter from EPA approves with modifications, the petition from Poet Biorefining Laddonia, Poet Laddonia Facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act f

  2. Joule Unlimited Technologies Approval

    EPA Pesticide Factsheets

    This March 29 letter from EPA approves the petition from Joule Unlimited Technologies, Inc. regarding ethanol produced through the Joule Helioculture Process under the Clean Air Act for renewable fuel [D-code 5] RINs under the RFS program.

  3. Approved Drugs for Adults

    MedlinePlus

    ... are 2 types of immune modulator drugs called “interferon” that are given as an injection for 6 ... year or two. (Approved in 1998) Immune Modulators (Interferons) Pegylated Interferon (Pegasys) is given by injection once ...

  4. Newborn Screening Tests Approved

    MedlinePlus

    ... The screens are used to detect four rare metabolic disorders To use the sharing features on this page, ... of screening tests designed to detect four rare metabolic disorders in newborns has been approved by the U.S. ...

  5. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... processes that do not alter the method of manufacture or change the final dosage form. (viii) A change in... drug residues. (xiii) A revised method of synthesis or fermentation of the new drug substance. (xiv) Updating or changes in the manufacturing process of the new drug substance and/or final dosage form (other...

  6. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... processes that do not alter the method of manufacture or change the final dosage form. (viii) A change in... drug residues. (xiii) A revised method of synthesis or fermentation of the new drug substance. (xiv) Updating or changes in the manufacturing process of the new drug substance and/or final dosage form (other...

  7. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... processes that do not alter the method of manufacture or change the final dosage form. (viii) A change in... drug residues. (xiii) A revised method of synthesis or fermentation of the new drug substance. (xiv) Updating or changes in the manufacturing process of the new drug substance and/or final dosage form (other...

  8. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... processes that do not alter the method of manufacture or change the final dosage form. (viii) A change in... drug residues. (xiii) A revised method of synthesis or fermentation of the new drug substance. (xiv) Updating or changes in the manufacturing process of the new drug substance and/or final dosage form (other...

  9. Nutritional supplements to increase muscle mass.

    PubMed

    Clarkson, P M; Rawson, E S

    1999-07-01

    Although nutritional supplements purported to increase muscle mass are widely available at health food stores, gyms, by mail order, and over the Internet, many of these supplements have little or no data to support their claims. This article reviews the theory and research behind popular nutritional supplements commonly marketed as muscle mass builders. Included are the minerals chromium, vanadyl sulfate, and boron, the steroid hormone dehydroepiandrosterone (DHEA), beta-methyl-hydroxy-beta-methylbutyrate (HMB), creatine, protein supplements, and amino acids. Research has shown that chromium vanadyl sulfate, and boron do not appear to be effective in increasing lean body mass. The few studies examining DHEA have not supported the claim of increased muscle gain. Preliminary work on HMB supports an anticatabolic effect, but only one human study is currently available. Many studies reported increased body mass and several have reported increased lean body mass following creatine ingestion. This weight gain is most likely water retention in muscle but could also be due to some new muscle protein. Although athletes have a greater protein requirement than sedentary individuals, this is easily obtained through the diet, negating the use of protein supplements. Studies on amino acids have not supported their claim to increase growth hormone or insulin secretion. Nutritional supplements can be marketed without FDA approval of safety or effectiveness. Athletes who choose to ingest these supplements should be concerned with unsubstantiated claims, questionable quality control, and safety of long-term use.

  10. [Efficacy of Chinese Herbs for Supplementing Qi and Activating Blood Circulation on Patients with Acute Coronary Syndrome and Type 2 Diabetes Mellitus after Percutaneous Coronary Intervention: a Clinical Observation].

    PubMed

    Du, Jian-peng; Wang, Cheng-long; Wang, Pei-li; Wang, Shao-li; Gao, Zhu-ye; Zhang, Da-wu; Xu, Hao; Shi, Da-zhuo

    2015-05-01

    To observe the efficacy of Chinese herbs for supplementing qi and activating blood circulation (CHSQABC) on patients with acute coronary syndrome (ACS) and type 2 diabetes mellitus (DM) after successful percutaneous coronary intervention (PCI). In this ChiCTR-TRC-00000021, a total of 281 ACS patients complicated with type 2 DM after successful PCI were randomly assigned to the Western medicine treatment group (the control group, treated by routine Western medicine treatment) and the combined treatment group (the treatment group, treated by CHSQABC + routine Western medicine treatment). Patients in the combined treatment group took Xinyue Capsule (2 pills each time, 3 times per day) and Compound Chuanxiong Capsule (2 pills each time, 3 times per day for half a year and 1-year follow-ups). Primary endpoints covered incidence of death, nonfatal myocardial infarction (MI), ischemia-driven revascularization, and secondary endpoints included stroke, heart failure, and rehospitalization for ACS. At the same time scores for blood stasis syndrome (BSS) and the incidence of angina pectoris were evaluated before treatment, at month 1, 3, 6, 9, and 12 after treatment. The incidence of ischemia-driven revascularization was obviously less in the treatment group than in the control group (P < 0.05). No patient had nonfatal MI in the treatment group, while 5 patients in the control group had it. The incidence of non-fatal MI showed an obvious lowering tendency in the treatment group, but with no statistical difference when compared with that in the control group (P > 0.05). Four patients readmitted to hospital in the treatment group, while 12 patients readmitted. There existed obvious tendency in the treatment group, but with no statistical difference when compared with that in the control group (P > 0.05). The incidence of angina was significantly lower in the treatment group at month 6, 9, and 12 than that at month 1 , but it was lower in the control group at 9 months (P < 0

  11. Vagus nerve stimulation therapy summary: five years after FDA approval.

    PubMed

    Schachter, Steven C

    2002-09-24

    With more than 16,000 patients implanted with the vagus nerve stimulation (VNS) therapy system (Cyberonics, Inc., Houston, Texas), VNS therapy has assumed an increasingly important role in the treatment of medically refractory seizures since its approval 5 years ago by the United States FDA. This review discusses the clinical trials that provided evidence for the approval, long-term efficacy, efficacy in special populations and co-morbid conditions, and safety and tolerability. Additional studies are suggested to further explore the capabilities of VNS therapy.

  12. Dietary supplements for dysmenorrhoea.

    PubMed

    Pattanittum, Porjai; Kunyanone, Naowarat; Brown, Julie; Sangkomkamhang, Ussanee S; Barnes, Joanne; Seyfoddin, Vahid; Marjoribanks, Jane

    2016-03-22

    Dysmenorrhoea refers to painful menstrual cramps and is a common gynaecological complaint. Conventional treatments include non-steroidal anti-inflammatory drugs (NSAIDs) and oral contraceptive pills (OCPs), which both reduce myometrial activity (contractions of the uterus). A suggested alternative approach is dietary supplements. We used the term 'dietary supplement' to include herbs or other botanical, vitamins, minerals, enzymes, and amino acids. We excluded traditional Chinese medicines. To determine the efficacy and safety of dietary supplements for treating dysmenorrhoea. We searched sources including the Cochrane Gynaecology and Fertility Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, PsycINFO (all from inception to 23 March 2015), trial registries, and the reference lists of relevant articles. We included randomised controlled trials (RCTs) of dietary supplements for moderate or severe primary or secondary dysmenorrhoea. We excluded studies of women with an intrauterine device. Eligible comparators were other dietary supplements, placebo, no treatment, or conventional analgesia. Two review authors independently performed study selection, performed data extraction and assessed the risk of bias in the included trials. The primary outcomes were pain intensity and adverse effects. We used a fixed-effect model to calculate odds ratios (ORs) for dichotomous data, and mean differences (MDs) or standardised mean differences (SMDs) for continuous data, with 95% confidence intervals (CIs). We presented data that were unsuitable for analysis either descriptively or in additional tables. We assessed the quality of the evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods. We included 27 RCTs (3101 women). Most included studies were conducted amongst cohorts of students with primary dysmenorrhoea in their late teens or early twenties. Twenty-two studies were

  13. Punishments: What Predicts Adult Approval.

    ERIC Educational Resources Information Center

    Buntain-Ricklefs, Joanne J.; And Others

    1994-01-01

    A survey of 449 parents found that 24% experienced uncommon punishments (such as burning) during their childhoods and 6% approved; 45% experienced and 17% approved of common punishments (shaking); and 94% experienced and 88% approved of very common punishments (spanking). Approval of each punishment was related to experience. Race, income, and…

  14. Ibrutinib: first global approval.

    PubMed

    Cameron, Fiona; Sanford, Mark

    2014-02-01

    Ibrutinib (Imbruvica™) is a small molecule, first-in-class, once-daily, orally available, Bruton's tyrosine kinase inhibitor that is under development for the treatment of B cell malignancies, including chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL), as well as multiple myeloma (MM), follicular lymphoma (FL) and Waldenstrom's macroglobulinemia (WM). It has been developed by Pharmacyclics, Inc. and Janssen Biotech, Inc. Ibrutinib acts by blocking B-cell antigen receptor signalling, thereby reducing malignant proliferation of B cells and inducing cell death. Based chiefly on findings from a phase Ib/II study, ibrutinib has been approved in the USA for the treatment of MCL in previously treated patients and is one of the first approvals through the US FDA's Breakthrough Therapy Designation Pathway. An application has been filed in the EU seeking regulatory approval in this indication. In both the USA and EU, further applications have been filed with regulatory bodies seeking approval for the use of ibrutinib in patients with previously treated CLL/small lymphocytic lymphoma (SLL). Phase III trials are underway worldwide to evaluate ibrutinib in the treatment of patients with CLL/SLL, DLBCL and MCL, and the agent is in phase II development for use in WM, FL and MM. This article summarizes the milestones in the development of ibrutinib leading to its first approval in MCL.

  15. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... shall forward the completed application form and other data to Approval and Certification Center which..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval...

  16. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... shall forward the completed application form and other data to Approval and Certification Center which..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval...

  17. Dulaglutide: first global approval.

    PubMed

    Sanford, Mark

    2014-11-01

    Dulaglutide (Trulicity™) is a long-acting, glucagon-like peptide-1 (GLP-1) receptor agonist that has been developed by Eli Lilly and Company for the treatment of type 2 diabetes mellitus. It consists of a dipeptidyl peptidase-IV-protected GLP-1 analogue covalently linked to a human IgG4-Fc heavy chain by a small peptide linker. The subcutaneous formulation is approved for use in type 2 diabetes in the US, has been recommended for approval in the EU in this indication, and is under regulatory review in other countries. This article summarizes the milestones in the development of subcutaneous dulaglutide leading to this first approval for type 2 diabetes.

  18. Blinatumomab: first global approval.

    PubMed

    Sanford, Mark

    2015-02-01

    Blinatumomab (BLINCYTO™) is a novel, bispecific T-cell engaging antibody that binds cluster of differentiation (CD) 19 antigens on blast cells while also binding and activating the CD3/T cell receptor complex, causing cell lysis. The antibody is being developed by Amgen as a treatment for haematological cancers that originate from B cell lines. Blinatumomab was approved by the US FDA in December 2014 for the treatment of adults with Philadelphia chromosome (Ph)-negative relapsed/refractory B-cell precursor acute lymphoblastic leukaemia (BCP-ALL). It is awaiting approval for this indication in the EU and is in phase III development in various countries. This article summarizes the milestones in the development of blinatumomab leading to its first approval for the treatment of Ph-negative BCP-ALL.

  19. Apremilast: first global approval.

    PubMed

    Poole, Raewyn M; Ballantyne, Anita D

    2014-05-01

    Apremilast (Otezla(®)), an oral small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4), is under development with Celgene Corporation for the treatment of psoriatic arthritis, psoriasis, ankylosing spondylitis, Behçet's syndrome, atopic dermatitis, and rheumatoid arthritis. Apremilast is indicated for the treatment of active psoriatic arthritis in adults. Apremilast has received its first global approval for this indication in the USA. Regulatory submissions for approval in this indication are under review in Canada and Europe. Regulatory filings have also been submitted for apremilast in the treatment of plaque psoriasis in the USA and Europe. This article summarizes the milestones in the development of apremilast leading to its first approval for the treatment of psoriatic arthritis.

  20. Five Supplements and Multiple Psychotic Symptoms: A Case Report

    PubMed Central

    Wong, Michelle K.; Darvishzadeh, Ayeh; Maler, Neal A.; Bota, Robert G.

    2016-01-01

    Dietary supplements, including vitamins, minerals, herbs, amino acids, and enzymes, have become increasingly more common and are used by approximately half of the US population. About three-fourths of supplements are obtained with no prescription from a physician, which raises medical concerns regarding safety as these products do not require US Food and Drug Administration approval. Common reasons for taking dietary supplements include improved mood, improved mental function, depression relief, anxiety reduction, and treatment of simple and migraine headaches. The use of herbs for medicinal purposes has a long-standing history among many cultures. We present the case of a 43-year-old man, who was taking dietary supplements, with a 6-month history of psychotic symptoms that increasingly caused impairment in functioning and eventually led to involuntary hospitalization. The published data with regard to supplements causing psychosis, herb-to-herb interaction, and reliability of herbal supplement manufacturers are discussed. PMID:27247830

  1. 46 CFR 8.430 - U.S. Supplement to class rules.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... authorization to participate in the ACP, a recognized classification society must prepare, and receive Commandant (CG-521) approval of, a U.S. Supplement to the recognized classification society's class rules... of that classification society or applicable international regulations....

  2. 75 FR 41161 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 251...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-15

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 251, Contractor Use of Government Supply Sources AGENCY: Defense Acquisition... extension of an approved information collection requirement. SUMMARY: In compliance with Section 3506(c)(2...

  3. Plecanatide: First Global Approval.

    PubMed

    Al-Salama, Zaina T; Syed, Yahiya Y

    2017-03-03

    Plecanatide (Trulance(TM)) is an oral guanylate cyclase-C agonist that is being developed by Synergy Pharmaceuticals for the treatment of gastrointestinal disorders, such as chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). It is a synthetic analogue of human uroguanylin, a 16 amino acid peptide that regulates ion and fluid transport in the gastrointestinal tract. In January 2017, plecanatide received its first global approval in the USA for the treatment of adult patients with CIC. Plecanatide is undergoing phase III investigation in IBS-C. This article summarizes the milestones in the development of plecanatide leading to this first approval in CIC.

  4. Etelcalcetide: First Global Approval.

    PubMed

    Blair, Hannah A

    2016-12-01

    Etelcalcetide (Parsabiv™) is a novel second generation calcimimetic agent developed by Amgen for the treatment of secondary hyperparathyroidism (SHPT), a complication of chronic kidney disease (CKD). Etelcalcetide reduces circulating levels of parathyroid hormone and calcium by binding directly to the calcium-sensing receptor. Intravenous etelcalcetide has been approved in the EU for the treatment of SHPT in adult patients with CKD on haemodialysis therapy. Regulatory applications for etelcalcetide in SHPT are also under review in the USA and Japan. This article summarizes the milestones in the development of etelcalcetide leading to this first global approval for the treatment of SHPT.

  5. The use of dietary supplements in oncology.

    PubMed

    Frenkel, Moshe; Sierpina, Victor

    2014-11-01

    The use of dietary supplements among patients affected by cancer is extensive, with an estimated 20-90 % of patients using these products. Their use of these products is often not shared with the treating physician. This is because patients perceive or believe that their physicians are indifferent or negative toward the use of dietary supplements. As a result, patients may obtain information about dietary supplements from unreliable sources, exposing themselves to unnecessary risks. Since there are limited scientific data on the efficacy and safety of many dietary supplements, advising patients about when to use them during the course of illness is a clinical challenge. Improving the communication process between the health care team and their patients in this area is critical. We describe a practical patient-centered approach to managing dietary supplement use in cancer care. This approach makes use of all available scientific data relating to the safety and efficacy of these supplements combined with how to have an open, patient-centered discussion with patients about their needs and expectations.

  6. Tyrosine Supplementation Attenuates Cognitive and Psychomotor Deficits in Cold Environments

    DTIC Science & Technology

    2009-01-01

    with a collection of information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. 1...Approved for public release; distribution unlimited In rats, dietary supplementation with the amino acid tyrosine (TYR) prevented depletion of central...that cold exposure degrades cognitive performance and supplementation with TYR alleviates working memory decrements, even with a reduced core

  7. Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems.

    PubMed

    Walter, Jessica R; Hayman, Emily; Tsai, Shelun; Ghobadi, Comeron W; Xu, Shuai

    2016-06-01

    Recent controversies surrounding obstetrics and gynecology devices, including a permanent sterilization device, pelvic meshes, and laparoscopic morcellators, highlight the need for deeper understanding of obstetrics and gynecology medical device regulation. The U.S. Food and Drug Administration premarket approval database was queried for approvals assigned to the obstetrics and gynecology advisory committee from January 2000 to December 2015. Eighteen device approvals occurred in the time period studied. The most common clinical indications included endometrial ablation (33%), contraception (28%), and fetal monitoring (17%). The median approval time was 290 days (range 178-1,399 days). Regarding the pivotal trials leading to approval, there were 11 randomized controlled trials, one randomized crossover study, five nonrandomized prospective studies, and two human factor studies. Fourteen devices (78%) met their primary clinical efficacy endpoint. Only 12 of 18 devices were required to conduct postmarket surveillance. A significant proportion of devices (42%) were approved on the basis of nonrandomized controlled trials. Three devices have been withdrawn after approval, all of which were either not referred or not recommended for approval by the obstetrics and gynecology advisory committee. Of the three devices withdrawn from the market, two failed to demonstrate clinical benefit in their pivotal trials. One device was not required to undergo postmarketing surveillance and was subsequently withdrawn as a result of patient safety concerns. Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices.

  8. REG Geismar Approval

    EPA Pesticide Factsheets

    This April 13, 2017 letter from EPA approves the petition from Renewable Energy Group, Inc. for renewable diesel produced from non-food grade corn oil as biomass-based diesel under the Clean Air Act and the Renewable Fuel Standard Program.

  9. Heartland Winthrop Approval

    EPA Pesticide Factsheets

    This May 19, 2016 letter from EPA approves the petition from Heartland Corn Products regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS program.

  10. Poet Leipsic Approval

    EPA Pesticide Factsheets

    This August 9, 2016 letter from EPA approves,wtih modifications, the petition from Poet Biorefining-Leipsic, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs

  11. Poet Fostoria Approval

    EPA Pesticide Factsheets

    This August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Fostoria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6)

  12. CORN, LP Goldfield Approval

    EPA Pesticide Factsheets

    This November 19, 2015 letter from EPA approves the petition from CORN, LP, Goldfield facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS pro

  13. FHR Iowa Falls Approval

    EPA Pesticide Factsheets

    This October 22, 2015, letter from EPA approves the petition from Flint Hills Resources, LLC, regarding non-grandfathered ethanol produced through the FHR Iowa Falls Process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the R

  14. FDA Approval for Imiquimod

    Cancer.gov

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  15. GI Course Approvals.

    ERIC Educational Resources Information Center

    Orlans, Harold; And Others

    The process by which institutions and courses are approved for veterans educational benefits is examined in this study mandated by Public Law 95-202. The legislative background of the investigation is described as well as the history of the Servicemen's Readjustment Act of 1944, the Korean Bill of 1952, and P.L. 94-502 of 1976. A summary guide to…

  16. Gevo, Inc. Approval

    EPA Pesticide Factsheets

    This December 22, 2016 letter from EPA approves the petition from Gevo, Inc. for butanol produced from corn starch and/or grain sorghum as renewable fuel and in some cases advanced biofuel under the Clean Air Act and the Renewable Fuel Standard Program.

  17. Venetoclax: First Global Approval.

    PubMed

    Deeks, Emma D

    2016-06-01

    Venetoclax (Venclexta™) is an oral selective inhibitor of the prosurvival protein BCL-2 and therefore restores the apoptotic ability of malignant cells. The drug arose from research by Abbott Laboratories (now AbbVie) during a collaboration with Genentech and is being co-developed by AbbVie and Genentech/Roche primarily for the treatment of haematological malignancies. Venetoclax is approved in the USA for use as monotherapy in patients with chronic lymphocytic leukaemia (CLL) with the 17p deletion (as detected by an approved FDA test) who have received at least one prior therapy, and is awaiting approval for similar indications in the EU and Canada. Venetoclax is also in phase I-III development as combination therapy for CLL, phase I/II development as monotherapy and/or combination therapy for non-Hodgkin lymphomas (including diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma) and acute myeloid leukaemia, and phase I development for multiple myeloma, systemic lupus erythematosus and breast cancer. This article summarizes the milestones in the development of venetoclax leading to this first approval for CLL.

  18. Didion Cambria Approval

    EPA Pesticide Factsheets

    This May 9, 2016 letter from EPA approves the petition from Didion Ethanol, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS program.

  19. Poet Lake Crystal Approval

    EPA Pesticide Factsheets

    This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS

  20. 78 FR 11808 - Approval and Promulgation of Implementation Plans; Tennessee: Approve Knox County Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... INFORMATION CONTACT: Kelly Sheckler, Air Quality Modeling and Transportation Section, Air Planning Branch, Air... revised ozone National Ambient Air Quality Standards (NAAQS). See 73 FR 16436. The current action, however... demonstrated that it is consistent with the Clean Air Act. DATES: Written comments must be received on...

  1. Approved drugs and their problems in patient care: routes of administration and dosing.

    PubMed

    Cook, Stuart D

    2007-08-15

    Problems in patient care with regard to route of administration and dosing of currently approved drugs are reviewed. Dose, frequency and route of administration can make a difference in efficacy, side effects, quality of life, antigenicity, cost, and compliance.

  2. Nutritional supplements and ergogenic AIDS.

    PubMed

    Liddle, David G; Connor, Douglas J

    2013-06-01

    Performance enhancing drugs, ergogenic aids, and supplements come in many forms. The financial, personal, social, and health-related impact of these substances has wide and varied consequences. This article reviews common substances and practices used by athletes. It discusses the history, use, effects, and adverse effects of androgenic anabolic steroids, peptide hormones, growth factors, masking agents, diuretics, volume expanders, β-blockers, amphetamines, caffeine, other stimulants, and creatine. The evidence base behind the use, safety, and efficacy of these items as well as testing for these substances is discussed.

  3. [Insufficient evidence supporting iron supplementation in anaemia during pregnancy].

    PubMed

    Wiegerinck, Melanie M; Mol, Ben Willem J

    2012-01-01

    The Royal Dutch Organization of Midwives (KNOV) recently presented their practice guideline 'Anaemia in midwifery practice'. The guideline identified available evidence on diagnosis, prognosis and treatment of anaemia in pregnancy. Anaemia based on iron deficiency and subsequent treatment with iron supplementation are probably the most frequent aspects of care for pregnant women. However, there is surprisingly enough no evidence of the efficacy of iron supplementation treatment on relevant clinical outcomes in pregnant women with anaemia. We plead to make the next guideline a multidisciplinary one. Such a guideline may lead to a large pragmatic trial evaluating the efficacy of iron supplementation treatment for patients with anaemia.

  4. 21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from... and ethical. Such postmarketing studies would not be feasible until an exigency arises. When such... studies become ethical and feasible. (2) Approval with restrictions to ensure safe use. If FDA concludes...

  5. 21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from... and ethical. Such postmarketing studies would not be feasible until an exigency arises. When such... studies become ethical and feasible. (2) Approval with restrictions to ensure safe use. If FDA concludes...

  6. 21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from... and ethical. Such postmarketing studies would not be feasible until an exigency arises. When such... studies become ethical and feasible. (2) Approval with restrictions to ensure safe use. If FDA concludes...

  7. 21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from... and ethical. Such postmarketing studies would not be feasible until an exigency arises. When such... studies become ethical and feasible. (2) Approval with restrictions to ensure safe use. If FDA concludes...

  8. 21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from... and ethical. Such postmarketing studies would not be feasible until an exigency arises. When such... studies become ethical and feasible. (2) Approval with restrictions to ensure safe use. If FDA concludes...

  9. Evaluating the Efficacy of Three U.S. Department of Agriculture-Approved Antimicrobial Sprays for Reducing Shiga Toxin-Producing Escherichia coli Surrogate Populations on Bob Veal Carcasses.

    PubMed

    2016-06-01

    Effective antimicrobial intervention strategies to reduce Shiga toxin-producing Escherichia coli (STEC) risks associated with veal are needed. This study evaluated the efficacy of lactic acid (4.5%, pH 2.0), Citrilow (pH 1.2), and Beefxide (2.25%, pH 2.3) for reducing STEC surrogates on prerigor and chilled bob veal carcasses and monitored the effects of these interventions on chilled carcass color. Dehided bob veal carcasses were inoculated with a five-strain cocktail of rifampin-resistant, surrogate E. coli bacteria.E. coli surrogates were enumerated after inoculation, after water wash, after prechill carcass antimicrobial spray application, after chilling for 24 h, and after postchill carcass antimicrobial spray application; carcass color was measured throughout the process. A standard carcass water wash (∼50°C) reduced the STEC surrogate population by 0.9 log CFU/cm(2) (P ≤ 0.05). All three antimicrobial sprays applied to prerigor carcasses delivered an additional ∼0.5-log reduction (P ≤ 0.05) of the surrogates. Chilling of carcasses for 24 h reduced (P ≤ 0.05) the surrogate population by an additional ∼0.4 log cycles. The postchill application of the antimicrobial sprays provided no further reductions. Carcass L*, a*, and b* color values were not different (P > 0.05) among carcass treatments. Generally, the types and concentrations of the antimicrobial sprays evaluated herein did not negatively impact visual or instrumental color of chilled veal carcasses. This study demonstrates that warm water washing, followed by a prechill spray treatment with a low-pH chemical intervention, can effectively reduce STEC risks associated with veal carcasses; this provides processors a validated control point in slaughter operations.

  10. A low-fat yoghurt supplemented with a rooster comb extract on muscle joint function in adults with mild knee pain: a randomized, double blind, parallel, placebo-controlled, clinical trial of efficacy.

    PubMed

    Solà, Rosa; Valls, Rosa-Maria; Martorell, Isabel; Giralt, Montserrat; Pedret, Anna; Taltavull, Núria; Romeu, Marta; Rodríguez, Àurea; Moriña, David; Lopez de Frutos, Victor; Montero, Manuel; Casajuana, Maria-Carmen; Pérez, Laura; Faba, Jenny; Bernal, Gloria; Astilleros, Anna; González, Roser; Puiggrós, Francesc; Arola, Lluís; Chetrit, Carlos; Martinez-Puig, Daniel

    2015-11-01

    Preliminary results suggested that oral-administration of rooster comb extract (RCE) rich in hyaluronic acid (HA) was associated with improved muscle strength. Following these promising results, the objective of the present study was to evaluate the effect of low-fat yoghurt supplemented with RCE rich in HA on muscle function in adults with mild knee pain; a symptom of early osteoarthritis. Participants (n = 40) received low-fat yoghurt (125 mL d(-1)) supplemented with 80 mg d(-1) of RCE and the placebo group (n = 40) consumed the same yoghurt without the RCE, in a randomized, controlled, double-blind, parallel trial over 12 weeks. Using an isokinetic dynamometer (Biodex System 4), RCE consumption, compared to control, increased the affected knee peak torque, total work and mean power at 180° s(-1), at least 11% in men (p < 0.05) with no differences in women. No dietary differences were noted. These results suggest that long-term consumption of low-fat yoghurt supplemented with RCE could be a dietary tool to improve muscle strength in men, associated with possible clinical significance. However, further studies are needed to elucidate reasons for these sex difference responses observed, and may provide further insight into muscle function.

  11. 21 CFR 314.60 - Amendments to an unapproved application, supplement, or resubmission.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW...) FDA generally assumes that when an original application, supplement to an approved application, or... the “initial review cycle.”) FDA may instead defer review of the amendment until the subsequent...

  12. FDA Approvals - Cancer Currents Blog

    Cancer.gov

    Blog posts on cancer drugs and devices approved by the Food and Drug Administration—including summaries of the evidence to support the approvals and what they mean for patients—from NCI Cancer Currents.

  13. Vitamin C supplementation in pregnancy.

    PubMed

    Rumbold, Alice; Ota, Erika; Nagata, Chie; Shahrook, Sadequa; Crowther, Caroline A

    2015-09-29

    Vitamin C supplementation may help reduce the risk of pregnancy complications such as pre-eclampsia, intrauterine growth restriction and maternal anaemia. There is a need to evaluate the efficacy and safety of vitamin C supplementation in pregnancy. To evaluate the effects of vitamin C supplementation, alone or in combination with other separate supplements on pregnancy outcomes, adverse events, side effects and use of health resources. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2015) and reference lists of retrieved studies. All randomised or quasi-randomised controlled trials evaluating vitamin C supplementation in pregnant women. Interventions using a multivitamin supplement containing vitamin C or where the primary supplement was iron were excluded. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Twenty-nine trials involving 24,300 women are included in this review. Overall, 11 trials were judged to be of low risk of bias, eight were high risk of bias and for 10 trials it was unclear. No clear differences were seen between women supplemented with vitamin C alone or in combination with other supplements compared with placebo or no control for the risk of stillbirth (risk ratio (RR) 1.15, 95% confidence intervals (CI) 0.89 to 1.49; 20,038 participants; 11 studies; I² = 0%; moderate quality evidence), neonatal death (RR 0.79, 95% CI 0.58 to 1.08; 19,575 participants; 11 studies; I² = 0%), perinatal death (average RR 1.07, 95% CI 0.77 to 1.49; 17,105 participants; seven studies; I² = 35%), birthweight (mean difference (MD) 26.88 g, 95% CI -18.81 to 72.58; 17,326 participants; 13 studies; I² = 69%), intrauterine growth restriction (RR 0.98, 95% CI 0.91 to 1.06; 20,361 participants; 12 studies; I² = 15%; high quality evidence), preterm birth (average RR 0.99, 95% CI 0.90 to 1.10; 22,250 participants; 16 studies; I² = 49%; high quality evidence

  14. 40 CFR 52.1272 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Mississippi § 52.1272 Approval status. With the exceptions set forth in this subpart, the Administrator approves Mississippi's plan for...

  15. PRN 96-4: Label Statements Involving Product Efficacy and Potential for Harm to Property

    EPA Pesticide Factsheets

    This notice explains EPA procedures in approving pesticide labels that include claims relating to the efficacy of agricultural pesticides and provides a warning to growers regarding reliance on label statements regarding pesticide efficacy.

  16. Provider and patient expectations for dietary supplement discussions.

    PubMed

    Tarn, Derjung M; Guzmán, Jennifer R; Good, Jeffrey S; Wenger, Neil S; Coulter, Ian D; Paterniti, Debora A

    2014-09-01

    Dietary supplement use in the United States is common. Patients can procure supplements without a prescription, and often do not disclose supplement use to their healthcare providers. Providers and patients may be uncertain about what would be appropriate or helpful in discussions of supplements during routine office visits. To explore provider and patient expectations for discussions of dietary supplements. Semi-structured interviews were conducted with a purposeful sample of healthcare providers from three specialties and their patients who reported taking supplements. Thirty-five outpatient providers (14 primary care, six integrative medicine, and 15 complementary and alternative medicine (CAM) providers) and 107 of their patients. Qualitative analysis of transcripts using grounded theory and iterative review. Both providers and patients raised twelve common topics about dietary supplements that they felt were important to discuss during office visits, such as: supplements taken; supplement risks (interactions, safety/harm, side effects/adverse events); treatment benefits; efficacy; alternative treatments; and patient expectations/preferences for treatment. Some topics were mentioned more frequently by providers than patients, such as how to take, reason for taking, and evidence for use. Providers raised several topics that were mentioned infrequently by patients. Supplement costs and regulations were not brought up by any patients, even though consideration of these topics could influence patient decisions to take supplements. Complementary healthcare providers brought up topics not mentioned by primary care providers, such as the importance of supplement brands and supplement mega-dosing. Patients and providers have concordant views about the need to discuss patient supplement use and ensure patient safety. Patients may undervalue, be unaware of, or discount information about cost or regulations that could affect their decision-making about supplement use

  17. Alirocumab: First Global Approval.

    PubMed

    Markham, Anthony

    2015-09-01

    Alirocumab (Praluent®) is a fully human monoclonal antibody developed by Regeneron Pharmaceuticals and Sanofi that has been approved in the US as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolaemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)-a down regulator of liver low-density lipoprotein (LDL)-receptors-thereby increasing the ability of the liver to bind LDL-cholesterol (LDL-C) and reducing levels of LDL-C in blood. It has been shown to reduce LDL-C levels in patients with hypercholesterolaemia, including HeFH, both as monotherapy and in conjunction with statin therapy. This article summarizes the milestones in the development of alirocumab leading to this first approval.

  18. Pitolisant: First Global Approval.

    PubMed

    Syed, Yahiya Y

    2016-09-01

    Pitolisant (Wakix™) is an inverse agonist of the histamine H3 receptor that is being developed by Bioproject. Oral pitolisant is approved in the EU for the treatment of narcolepsy with or without cataplexy in adults. Pitolisant has received a Temporary Authorization of Use in France for this indication in case of treatment failure, intolerance or contraindication to currently available treatment. Pitolisant has orphan drug designation in the EU and the USA. In the pivotal HARMONY I trial, pitolisant significantly decreased excessive daytime sleepiness versus placebo in adults with narcolepsy with or without cataplexy (primary endpoint). Pitolisant also significantly decreased cataplexy rate versus placebo in these patients. This article summarizes the milestones in the development of pitolisant leading to this first approval for narcolepsy.

  19. Linaclotide: first global approval.

    PubMed

    McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

    2012-11-12

    Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

  20. Olaparib: first global approval.

    PubMed

    Deeks, Emma D

    2015-02-01

    Olaparib (Lynparza™) is an oral, small molecule, poly (ADP-ribose) polymerase inhibitor being developed by AstraZeneca for the treatment of solid tumours. The primary indication that olaparib is being developed for is BRCA mutation-positive ovarian cancer. A capsule formulation of the drug has received approval for use in this setting in the EU and USA, and a tablet formulation is in global phase III trials (including in the USA, EU, Australia, Brazil, Canada, China, Israel, Japan, Russia and South Korea). In addition, phase III trials in breast, gastric and pancreatic cancer are underway/planned, and phase I/II investigation is being conducted in other malignancies, including prostate cancer, non-small cell lung cancer, Ewing's sarcoma and advanced cancer. This article summarizes the milestones in the development of olaparib leading to this first approval for ovarian cancer.

  1. Cariprazine: First Global Approval.

    PubMed

    McCormack, Paul L

    2015-11-01

    Cariprazine (Vraylar) is an oral atypical antipsychotic originated by Gedeon Richter. It is a potent dopamine D3 and D2 receptor partial agonist, which preferentially binds to the D3 receptor. Cariprazine also has partial agonist activity at serotonin 5-HT1A receptors. In September 2015, cariprazine received its first global approval in the USA for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder. It is also in development in a variety of countries for the treatment of schizophrenia with predominant negative symptoms (phase III), as adjunctive therapy for major depressive disorder (phase II/III) and for the treatment of bipolar depression (phase II). This article summarizes the milestones in the development of cariprazine leading to this first approval for schizophrenia and manic or mixed episodes associated with bipolar I disorder.

  2. Sarilumab: First Global Approval.

    PubMed

    Scott, Lesley J

    2017-04-01

    Sarilumab (Kevzara™) is a fully human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound interleukin (IL)-6 receptors (sIL-6Rα and mIL-6Rα) and thereby inhibits IL-6-mediated signalling through these receptors. Subcutaneous sarilumab is approved in Canada for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more biological or non-biological disease-modifying anti-rheumatic drugs. It is under regulatory review for use in rheumatoid arthritis in other countries, including in the EU, USA and Japan. Sarilumab is also under phase II investigation for the treatment of juvenile idiopathic arthritis. This article summarizes the milestones in the development of sarilumab leading to its first global approval for the treatment of rheumatoid arthritis.

  3. Yucca Mountain repository approved

    NASA Astrophysics Data System (ADS)

    Showstack, Randy

    At a quiet White House ceremony on 23 July, U.S. President George W. Bush signed into law House Joint Resolution 87, which approves the site at Yucca Mountain, Nevada, for the development of a repository for disposing of high-level radioactive waste and spent nuclear fuel.White House spokesman Ari Fleischer called the signing “an important step forward on the way to a comprehensive policy for dealing with our nation's nuclear waste.”

  4. 21 CFR 515.11 - Supplemental medicated feed mill license applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Supplemental medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Applications § 515.11 Supplemental medicated feed mill license applications. (a) After approval of a medicated feed...

  5. Baricitinib: First Global Approval.

    PubMed

    Markham, Anthony

    2017-03-13

    Baricitinib (Olumiant™) is an orally-administered, small-molecule, janus-associated kinase (JAK) inhibitor developed by Eli Lilly and Incyte Corporation for the treatment of rheumatoid arthritis (RA), atopic dermatitis and systemic lupus erythematosus. JAKs transduce intracellular signals from cell surface receptors for various cytokines and growth factors involved in inflammation and immune function, suggesting JAK inhibitors may be of therapeutic benefit in inflammatory conditions. In February 2017, baricitinib was approved in the EU, as monotherapy or in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Regulatory approval to market baricitinib as a treatment for RA has also been sought in the USA and Japan. This article summarizes the milestones in the development of baricitinib leading to this first global approval for the treatment for moderate to severe active RA in adult patients who have responded inadequately to, or are intolerant to one or more DMARDs.

  6. Osimertinib: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-02-01

    Osimertinib (Tagrisso(™), AZD9291) is an oral, third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that is being developed by AstraZeneca for the treatment of advanced non-small cell lung cancer (NSCLC). Osimertinib has been designed to target the EGFR T790M mutation that is often present in NSCLC patients with acquired EGFR TKI resistance, while sparing wild-type EGFR. In November 2015, the tablet formulation of osimertinib was granted accelerated approval in the USA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC (as detected by an FDA-approved test) who have progressed on or after EGFR TKI therapy. Osimertinib has also been granted accelerated assessment status for this indication in the EU, and is in phase III development for first- and second-line and adjuvant treatment of advanced EGFR mutation-positive NSCLC in several countries. Phase I trials in patients with advanced solid tumours are also being conducted. This article summarizes the milestones in the development of osimertinib leading to this first approval for NSCLC.

  7. Tasimelteon: first global approval.

    PubMed

    Dhillon, Sohita; Clarke, Madeleine

    2014-03-01

    Tasimelteon (HETLIOZ™) is an orally bioavailable agonist of the melatonin MT1 and MT2 receptors that has been approved in the US for the treatment of non-24-hour sleep-wake disorder. It is the first US FDA-approved medication for this orphan indication. Melatonin is thought to play a role in governing the body's natural sleep-wake cycle through physiological processes regulated in the suprachiasmatic nucleus of the hypothalamus. The hormone is secreted by the pineal gland, with onset typically occurring when daylight begins to dim. In healthy, sighted individuals, the endogenous circadian period is a little over 24 hours, but is entrained to the 24-hour day through exposure to environmental cues, such as light and darkness. In the absence of these cues, synchronisation is lost and the circadian rhythm follows the intrinsic non-24-hour clock, resulting in disorders like non-24-hour sleep-wake disorder. Because the rhythm of endogenous melatonin is considered to be a measure of the human circadian phase, the carefully timed administration of melatonin analogues, such as tasimelteon, can potentially promote circadian readjustment. This article summarizes the milestones in the development of tasimelteon leading to this first approval for the treatment of non-24-hour sleep-wake disorder.

  8. Dolutegravir: first global approval.

    PubMed

    Ballantyne, Anita D; Perry, Caroline M

    2013-09-01

    Dolutegravir, an orally administered HIV-1 integrase strand transfer inhibitor (INSTI), is under development by ViiV Healthcare. Like other drugs belonging in the INSTI class of antiretroviral agents, dolutegravir binds to the integrase site of HIV-1 and blocks the strand transfer integration step, thereby preventing the replication of HIV-1. Dolutegravir is being developed as an unboosted once-daily therapy for use in combination with other antiretroviral agents for the treatment of both treatment-naïve and treatment-experienced patients with HIV-1 infection. Dolutegravir has been approved in the USA for the treatment of HIV-1 infection in combination with other antiretroviral agents and has been filed for approval in the EU and Canada. Phase III development is underway in North America, Europe, South Africa, South America, Australia and Taiwan. This article summarizes the milestones in the development of dolutegravir leading to this first approval for the treatment of HIV-1 infection in both therapy-naïve and -experienced patients.

  9. Ipilimumab: first global approval.

    PubMed

    Cameron, Fiona; Whiteside, Glenn; Perry, Caroline

    2011-05-28

    Ipilimumab (Yervoy®) is an anti-cytotoxic T-lymphocyte antigen (CTLA)-4 monoclonal antibody that has been approved in the US for the first- or second-line treatment of patients with malignant melanoma. In the EU, it is awaiting approval as second-line therapy for melanoma. Ipilimumab blocks the effects of the negative T-cell regulator CTLA-4, which may in turn augment T-cell responses to tumour cells. Preclinical studies have indicated that antibody blocking of CTLA-4 can lead to potent immune responses. Ipilimumab is also in development as first- and second-line therapy for prostate cancer where it has progressed to phase III clinical trials worldwide, and it is in phase II development for non-small cell lung cancer. Ipilimumab was originated by the University of California, Berkeley, in the US and subsequently licensed to Medarex, which was later acquired by Bristol-Myers Squibb. This article summarizes the milestones in the development of intravenous ipilimumab leading to this first approval. This profile has been extracted from Wolters Kluwer's R&D Insight drug pipeline database. R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

  10. Vortioxetine: first global approval.

    PubMed

    Gibb, Andrew; Deeks, Emma D

    2014-01-01

    Vortioxetine is an orally administered small molecule developed by Lundbeck A/S for the once-daily treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD). Vortioxetine received its first global approval for MDD in the USA in September 2013 and regulatory approval for its use in this indication in the EU (where it has received a positive opinion) and Canada is awaited. The drug is a bis-aryl-sulphanyl amine compound that combines serotonin (5-HT) reuptake inhibition with other characteristics, including receptor activity modulation. In vitro studies indicate that vortioxetine is an inhibitor of the 5-HT transporter and is a 5-HT(1D), 5-HT₃ and 5-HT₇ receptor antagonist, a 5-HT(1A) receptor agonist and a 5-HT(1B) receptor partial agonist. Animal and in vitro studies indicate that several neurotransmitter systems may be impacted by vortioxetine, with the drug enhancing levels of 5-HT, noradrenaline, dopamine, acetylcholine and histamine in certain areas of the brain, as well as modulating γ-aminobutyric acid and glutamate neurotransmission. Phase III trials of vortioxetine in both MDD and GAD have been conducted worldwide. This article summarizes the milestones in the development of vortioxetine leading to this first approval for MDD.

  11. 15 CFR 921.31 - Supplemental acquisition and development awards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AND COASTAL RESOURCE MANAGEMENT NATIONAL ESTUARINE RESEARCH RESERVE SYSTEM REGULATIONS Reserve Designation and Subsequent Operation § 921.31 Supplemental acquisition and development awards. After National Estuarine Research Reserve designation, and as specified in the approved management plan, a coastal state...

  12. Specialty and Systems Engineering Supplement to IEEE 15288.1

    DTIC Science & Technology

    2017-08-28

    SMC Tailoring SMC-T-006 28 August 2017 ------------------------ Supersedes: SMC-T-006 (2015) Air Force Space Command... SPACE AND MISSILE SYSTEMS CENTER TAILORING SPECIALTY AND SYSTEMS ENGINEERING SUPPLEMENT TO IEEE-15288.1 APPROVED FOR PUBLIC...is critical to high-reliability space systems for optimizing total system performance and total ownership costs, while ensuring that the system is

  13. Risk Management Supplement to IEEE-15288.1

    DTIC Science & Technology

    2015-05-15

    AND MISSILE SYSTEMS CENTER TAILORING RISK MANAGEMENT SUPPLEMENT TO IEEE -15288.1 APPROVED FOR PUBLIC RELEASE...IEC- IEEE -15288: 2015, SYSTEMS AND SOFTWARE ENGINEERING — SYSTEM LIFE CYCLE PROCESSES...1 2.2. IEEE -15288.1: 2015, STANDARD FOR APPLICATION OF SYSTEMS ENGINEERING ON DEFENSE PROGRAMS

  14. 29 CFR 1953.4 - Submission of plan supplements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (CONTINUED) CHANGES TO STATE PLANS § 1953.4 Submission of plan supplements. (a) Developmental changes. (1... forth in its plan, as developmental steps, those changes which must be made to its initially-approved... these changes. The State must notify OSHA of a developmental change when it completes a developmental...

  15. [Isoflavone-containing dietary supplements].

    PubMed

    Lehmann, Leane; Soukup, Sebastian T; Gerhäuser, Clarissa; Vollmer, Günter; Kulling, Sabine E

    2017-03-01

    Isoflavones (IFs) from soy and other legumes have weak estrogenic properties. Isolated IFs are available as dietary supplements and advertised to alleviate symptoms of menopause. The present chapter provides an overview of the occurrence, the chemical structure of IFs and their metabolites, the market situation and reviews the current evidence on the efficacy and safety of IF-containing dietary supplements.The biological effectiveness of IFs is attributable to the activation of the estrogen receptor (ER). Studies on the influence of IFs on endogenous estrogen levels in women show inconsistent results. So far, the European Food Safety Authority (EFSA) has rejected all submitted health claims for IFs due to insufficient scientific evidence for any of the postulated health effects. Based on the results of their recent risk assessment, the EFSA concluded that the available human studies did not support the hypothesis of adverse effects of isolated IFs on the human mammary gland, uterus or thyroid in healthy postmenopausal women. However, the assessment does not allow a general statement on the safety of IF-containing dietary supplements. Studies in animal models are often not comparable with the complex interactions in humans due to differences in the metabolism of IFs, in the developmental stage at time of consumption and in the temporarily restricted uptake of IFs during certain stages of life.

  16. Nutritional supplements and alternative medicine.

    PubMed

    Krueger, Kristine J; McClain, Craig J; McClave, Stephen A; Dryden, Gerald W

    2004-03-01

    A major health care trend in the last decade has been the increased use of complementary and alternative medicine and nutritional supplements. Indeed, we now have Physician's Desk References for both herbal therapies and dietary supplements. A large amount of out-of-pocket dollars are spent on complementary and alternative medicine each year in the United States, and complementary and alternative medicine users believe strongly in the efficacy of their treatments. In the area of inflammatory bowel disease, probiotics appear to be a highly promising form of therapy. In acute pancreatitis, enteral nutrition has been shown to be safe and effective. Peppermint oil is one of the most widely used complementary and alternative medicine therapies for irritable bowel syndrome. Antioxidants are increasingly used in liver disease, especially agents involved in methionine metabolism. Both S-adenosylmethionine and betaine have shown efficacy in animal models of alcoholic liver disease, and "knockout" mice that develop S-adenosylmethionine deficiency also develop steatohepatitis. Thus, there is great interest in these complementary and alternative medicine agents in both alcoholic liver disease and nonalcoholic steatohepatitis. There are also important safety issues related to complementary and alternative medicine. Deaths of well-known athletes have highlighted the risks of ephedra, and some research suggests that complementary and alternative medicine agents are a major cause of fulminant liver failure necessitating liver transplantation. Thus, physicians must be aware not only of the potential therapeutic benefits of complementary and alternative medicine agents and nutritional supplements, but also their potential risks, including toxicity and drug interactions.

  17. Randomized study of the safety and efficacy of fish oil (omega-3 fatty acid) supplementation with dietary and exercise counseling for the treatment of antiretroviral therapy-associated hypertriglyceridemia.

    PubMed

    Wohl, David A; Tien, Hsiao-Chuan; Busby, Marjorie; Cunningham, Catherine; Macintosh, Beth; Napravnik, Sonia; Danan, Elisheva; Donovan, Kimberly; Hossenipour, Mina; Simpson, Ross J

    2005-11-15

    Omega-3 fatty acids (fish oils) reduce fasting serum triglyceride levels and cardiovascular disease risk in individuals without HIV infection. Whether omega-3 fatty acid supplementation can reduce hypertriglyceridemia associated with antiretroviral therapy is not known. We conducted an open-label, randomized trial that enrolled 52 patients receiving > or =3 active antiretrovirals who had fasting triglyceride levels of >200 mg/dL and were randomized to receive nutritionist-administered dietary and exercise counseling with or without fish oil supplementation for 16 weeks. Patients assigned to receive fish oil experienced a 25% mean decline in fasting triglyceride levels at week 4 (95% CI, -34.6% to -15.7% change), compared with a 2.8% mean increase among patients assigned to receive counseling alone (95% CI, -17.5% to +23.1% change) (P=.007). By week 16, the mean reduction in triglyceride levels in the fish oil arm remained significant, at 19.5% (95% CI, -34.9% to -4.0% change), whereas the mean decrease in the diet and exercise only arm was 5.7% (95% CI, -24.6% to +13.2% change); however, the difference between study arms was no longer statistically significant (P=.12). Low-density lipoprotein cholesterol levels had increased by 15.6% (95% CI, +4.8% to +26.4% change) at week 4 and by 22.4% (95% CI, +7.91% to +36.8% change) at week 16 in the fish oil arm but did not change in the diet and exercise only group. Fish oil was well tolerated; only 1 patient experienced treatment-limiting toxicity. Patients assigned to receive fish oil experienced a 25% mean decline in fasting triglyceride levels at week 4 (95% CI, -34.6% to -15.7% change), compared with a 2.8% mean increase in patients assigned to receive counseling alone (95% CI, -17.5% to 23.1% change) (P=.007). By week 16, the mean reduction in triglyceride levels in the fish oil arm remained significant, at 19.5% (95% CI, -34.9% to -4.0% change), whereas the mean decrease in the diet and exercise only arm was 5.7% (95

  18. Bovine somatotropin supplementation of dairy cows. Is the milk safe?

    PubMed

    Daughaday, W H; Barbano, D M

    Complex, biologically active proteins (eg, enzymes and hormones) can be manufactured safely and cost-effectively through applications of biotechnology. Some of these proteins (eg, human insulin, human somatotropin, rennet for cheese manufacture) are currently approved for medical or food processing applications. Bovine somatotropin (bST) for lactating dairy cattle is another product that can be produced via biotechnology and may allow dairy farmers to produce milk at a lower cost. In 1985, based on an evaluation of toxicological data, the Food and Drug Administration concluded that milk and meat from bST-supplemented cows was safe and wholesome. The Food and Drug Administration has authorized the use of milk and meat from bST-supplemented cows in the commercial food supply. Its evaluation of the impact of bST supplementation on the long-term health of dairy cattle is near completion, and bST may be approved for commercial use in early 1991.

  19. House approves Competitiveness Bill

    NASA Astrophysics Data System (ADS)

    Bush, Susan

    After nearly 3 weeks of debate, the House approved the National Competitiveness Act of 1993 (HR820) on May 19. Subtitle B of the bill lays out specific roles for the National Science Foundation in supporting expansion of the agency's activities to include manufacturing technology development, worker training partnerships, and total quality management programs.Many geoscientists believe that this mandate runs contradictory to NSF's established mission of supporting basic research (Eos, April 13, 1993) and are concerned that basic research funds might be diverted to support manufacturing within the agency.

  20. The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled trial.

    PubMed

    Luger, Maria; Kruschitz, Renate; Marculescu, Rodrig; Haslacher, Helmuth; Hoppichler, Friedrich; Kallay, Enikö; Kienbacher, Christian; Klammer, Carmen; Kral, Melanie; Langer, Felix; Luger, Eva; Prager, Gerhard; Trauner, Michael; Traussnigg, Stefan; Würger, Tanja; Schindler, Karin; Ludvik, Bernhard

    2015-08-05

    Beyond its classical role in calcium homoeostasis and bone metabolism, vitamin D deficiency has been found to be associated with several diseases, including diabetes, non-alcoholic fatty liver disease, and even obesity itself. Importantly, there are limited data on therapeutic strategies for vitamin D deficiency in bariatric patients, and the procedure-specific guidelines may not be sufficient. To improve long-term outcomes, nutritional screening and appropriate supplementation to prevent nutrient deficiencies are urgently needed. Therefore, the aim of this study is to examine effects and safety of a forced dosing regimen of vitamin D versus conventional dose supplementation on vitamin D levels and other parameters in bariatric patients. The study includes loading plus repeat dosing compared with repeated administration of vitamin D without a loading dose, according to guidelines, in a prospective, double-blind, randomized controlled trial. Up to a triple oral loading dose is given on day 1, then 2 and 4 weeks after surgery (100,000 IU dose each time), followed by an oral maintenance dose (3420 IU/day). The control group (n = 25) will receive placebo, followed by administration of a standard dose (3420 IU/day). We hypothesize that a significant increase in vitamin D levels will occur in patients in the treatment group (n = 25) by 24 weeks after surgery. Further measurements are aimed at evaluating changes in inflammation, bone turnover, insulin resistance, blood pressure, liver, mental health, and gut microbiota of patients undergoing omega-loop gastric bypass surgery. Furthermore, possible associations between concentrations of vitamin D, the involved enzymes, or vitamin D receptor in adipose and/or liver tissues will be determined. To our knowledge, this trial is the first of its kind with this type of vitamin D supplementation in bariatric patients. Its major strength is the design and implementation of evaluation of influencing factors such as liver

  1. Efficacy of High-Dose Supplementation With Oral Vitamin D3 on Depressive Symptoms in Dialysis Patients With Vitamin D3 Insufficiency: A Prospective, Randomized, Double-Blind Study.

    PubMed

    Wang, Ying; Liu, Ying; Lian, Yueying; Li, Ning; Liu, Hong; Li, Guanzeng

    2016-06-01

    Psychological problems are common among end-stage renal disease patients undergoing dialysis. We aim to evaluate whether high-dose vitamin D3 (VD3) supplementation has beneficial effects on depressive symptoms in dialysis patients. This prospective, randomized, and double-blind trial includes 746 dialysis patients with depression treated in 3 hospitals in Southeast China. Depression was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders criteria. Patients were randomly assigned to 52-week treatment of oral 50,000 IU/wk VD3 (cholecalciferol) (test group) or a placebo (control group). The presence of depressive symptoms was evaluated using the Chinese version of Beck Depression Inventory (BDI) II both before and after treatment. Sociodemographic data, clinical data, nutritional indexes, inflammatory biomarkers, and plasma VD3 concentrations were also determined. Finally, 726 patients completed the experiments, including 362 tested patients and 364 controls. After 52 weeks, the depressive symptoms were not significantly improved in the test group (mean BDI II scores changed from -1.1 ± 0.3 to -3.1 ± 0.6) versus the control group. Multivariable logistic regression showed BDI scores were not significantly improved in the test group versus the control group with adjustment for age, sex, comorbidity index, dialysis modality, or (OH)D levels (multivariable-adjusted mean change or MAMC [95% confidence interval (CI)], -2.3 [-2.48 to -1.83]) in the whole dialysis population. After stratification by depression types, the findings do support a significant relationship between the VD3 supplementation and the improvement in BDI II scores in dialysis patients with vascular depression (MAMC [95% CI], -4.4 [-5.08 to -2.76]), but the effect was not significant for major depressive disorders (MAMC [95% CI], -0.9 [-1.52 to -0.63]). The high-dose VD3 supplementation did not significantly reduce the depressive symptoms in our total dialysis population, but

  2. Lesinurad: First Global Approval.

    PubMed

    Hoy, Sheridan M

    2016-03-01

    Lesinurad (ZURAMPIC(®)) is an oral urate-anion exchanger transporter 1 (URAT1) inhibitor developed by Ardea Biosciences (a subsidiary of AstraZeneca) for the treatment of hyperuricaemia associated with gout. It reduces serum uric acid (sUA) levels by inhibiting the function of the transporter proteins (URAT1 and organic anion transporter 4) involved in uric acid reabsorption in the kidney. In December 2015, lesinurad was approved in the USA as combination therapy with a xanthine oxidase inhibitor for the treatment of hyperuricaemia associated with gout in patients who have not achieved sUA target levels with a xanthine oxidase inhibitor alone. Lesinurad has also received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for this indication and is in phase III development as a combination therapy in several other countries. This article summarizes the milestones in the development of lesinurad leading to this first approval for hyperuricaemia associated with gout.

  3. Safinamide: first global approval.

    PubMed

    Deeks, Emma D

    2015-04-01

    Safinamide (Xadago(®)) is an oral α-aminoamide derivative developed by Newron for the treatment of Parkinson's disease (PD). The drug has both dopaminergic properties (highly selective and reversible inhibition of monoamine oxidase-B) and non-dopaminergic properties (selective sodium channel blockade and calcium channel modulation, with consequent inhibition of excessive glutamate release). Safinamide is approved in the EU, Iceland, Lichtenstein and Norway, as an add-on therapy to stable-dose levodopa, alone or in combination with other PD therapies in mid- to late-stage fluctuating PD patients; regulatory submissions have also been filed in the USA and Switzerland for its use in this indication. Additional submissions have been made in the USA, Iceland, Lichtenstein, Norway and Switzerland for early-stage PD. Safinamide has also undergone phase II investigation in PD patients with drug-induced dyskinesia (France, Germany, Austria, Canada and South Africa) or cognitive impairment (USA and Spain). This article summarizes the milestones in the development of safinamide leading to its first approval for PD.

  4. Niraparib: First Global Approval.

    PubMed

    Scott, Lesley J

    2017-06-01

    Oral niraparib, a highly-selective, potent poly(ADP-ribose) polymerase (PARP)-1 and PARP-2 inhibitor, is approved in the USA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. It is also under regulatory review in the EU for use in maintenance treatment in patients with platinum-sensitive, recurrent epithelial ovarian cancer who are in response to platinum-based chemotherapy. In the multinational, phase 3 NOVA trial in adult patients with platinum-sensitive, recurrent ovarian cancer, niraparib significantly prolonged median progression-free survival, irrespective of the presence or absence of a germline BRCA (gBRCA) mutation and irrespective of the presence or absence of homologous recombinant deficiency. Niraparib is also in development for use in other solid tumours, including breast and prostate cancer. This article summarizes the milestones in the development of niraparib leading to its first global approval for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.

  5. Obinutuzumab: first global approval.

    PubMed

    Cameron, Fiona; McCormack, Paul L

    2014-01-01

    Obinutuzumab (Gazyva™) is an intravenously administered, humanized and glycoengineered, type II anti-CD20 monoclonal antibody for the treatment of B-cell malignancies. It is approved in the US for use in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukaemia (CLL), and has been filed for approval in the EU in this indication. The antibody is based on GlycArt Biotechnology's (later Roche Glycart AG) proprietary GlycoMAb® technology, which uses glycoengineered antibodies that specifically increase antibody-dependent cellular cytotoxicity and thereby increase immune-mediated target cell death. Obinutuzumab is a type II anti-CD20 antibody that induces enhanced direct cell death. The monoclonal antibody is in worldwide phase III development with Roche and its subsidiaries, Genentech and Chugai Pharmaceutical, as well as Biogen Idec, for diffuse large B-cell lymphoma and non-Hodgkin's lymphoma generally, and is also in phase III development in countries outside of the US and EU for CLL.

  6. Lenvatinib: first global approval.

    PubMed

    Scott, Lesley J

    2015-04-01

    Lenvatinib (Lenvima™) is a multitargeted receptor kinase inhibitor that inhibits the kinase activities of vascular endothelial-derived growth factor receptors 1, 2 and 3, fibroblast growth factor receptors 1, 2, 3 and 4, platelet-derived growth factor receptor α, RET and KIT. In addition to their role in normal cellular function, these kinases have been implicated in pathogenic angiogenesis, tumour growth and cancer progression. Lenvatinib is being developed by Eisai Co. Ltd for the treatment of solid tumours, primarily for differentiated thyroid cancer, and other malignancies. A capsule formulation of the drug has received approval in the USA for use in locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Lenvatinib is in pre-registration for this indication in the EU, Australia, Brazil, Canada, Japan, South Korea, Russia, Singapore and Switzerland, and is in phase 3 development in Argentina, Chile and Thailand. Lenvatinib has orphan designation in the EU and Japan for use in differentiated thyroid cancer. In addition, an ongoing global, phase 3 trial is evaluating the use of lenvatinib as first-line treatment in unresectable hepatocellular carcinoma. This article summarizes the milestones in the development of lenvatinib leading to this first approval in locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

  7. The dilemma of approving antidotes.

    PubMed

    Steffen, Christian

    2007-04-20

    Clinical trials with antidotes are difficult to perform for a variety of practical, ethical, and financial reasons. As acute poisoning is a rare event, the commercial interest in basic and clinical research is low. Poisoned patients are usually not available for normal clinical trial procedures and, if they are, they cannot give informed consent. This situation results in a dilemma: antidotes are essential drugs. A resolution of the Council of Europe requests to guarantee the optimal availability of antidotes and the improvement of their use. As comprehensive data on the efficacy of antidotes are often missing, a marketing authorisation under exceptional circumstances according to Article 14(8) of Regulation (EC) No. 276/2004, will often be the only way to get an approval, as: (1) the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence ("orphan drug"), (2) in the present state of scientific knowledge, comprehensive information cannot be provided, or (3) it would be contrary to generally accepted principles of medical ethics to collect such data. Typically, data on antidotes are obtained from a patchwork of studies with animals, human tissue and a few observations from human poisoning corroborated with data from clinical observations and biochemistry. Generalisations from chemical and mechanistic similarities between groups of poisons are usual, but often lack scientific evidence. Current standards of good clinical practice can rarely be observed. Therefore, public funding and other financial support are necessary incentives to initiate trials in this important area.

  8. DIETARY SUPPLEMENT HYMECROMONE AND SORAFENIB: A NOVEL COMBINATION FOR THE CONTROL OF RENAL CELL CARCINOMA

    PubMed Central

    Benitez, Anaid; Yates, Travis J; Shamaldevi, N.; Bowen, Tim; Lokeshwar, Vinata B.

    2016-01-01

    PURPOSE Current treatments for metastatic RCC (mRCC) do not extend survival beyond a few months. Sorafenib (SF) is a targeted drug approved for mRCC, but it has modest efficacy. Hymecromone is a nontoxic dietary supplement with some antitumor activity at high doses (450 – 3000 mg/day). HC inhibits hyaluronic acid (HA) synthesis. HA promotes tumor growth and metastasis. We recently showed that HA-receptors CD44 and RHAMM are potential predictors of mRCC. We examined the anti-tumor properties of HC, SF, and their combination in RCC models. METHODS Using proliferation, clonogenic and apoptosis assays, effects of HC (0–32 μg/ml), SF (0–3.2 μg/ml) and HC+SF were examined in RCC cells (Caki–1, 786–O, ACHN, A498) and endothelial cells (HMVEC–L, HUVEC). Boyden chamber was used for motility and invasion assays. Apoptosis indicators, HA receptors, EGFR and c-Met were evaluated by immunoblotting. Efficacy of HC, SF and HC+SF was evaluated in the SF-resistant Caki–1 xenograft model. RESULTS HC+SF synergistically inhibited proliferation (>95%), motility/invasion (65%) and capillary formation (76%) in RCC and/or endothelial cells, and induced apoptosis by 8-fold (P<0.001). HC+SF inhibited HA synthesis and HA addition reversed the cytotoxicity of HC+SF. HC+SF up-regulated pro-apoptotic indicators and downregulated Mcl-1, CD44, RHAMM, phospho-EGFR and phospho-cMet levels. In all assays, HC and SF alone were ineffective. Oral administration of HC (50–200mg/kg) plus SF (30mg/kg) eradicated Caki–1 tumor growth without toxicity. HC and SF alone were ineffective. CONCLUSION This is the first study that demonstrates combination of SF with HC a non–toxic dietary supplement is highly effective in controlling RCC. PMID:23228386

  9. Food modification versus oral liquid nutrition supplementation.

    PubMed

    Silver, Heidi J

    2009-01-01

    Oral liquid nutrition supplements (ONS) are widely used in community, residential and healthcare settings. ONS are intended for individuals whose nutrient requirements cannot be achieved by conventional diet or food modification, or for the management of distinctive nutrient needs resulting from specific diseases and/or conditions. ONS appear to be most effective in patients with a body mass index of efficacy of food-based versus ONS nutrition interventions.

  10. Approved and experimental countermeasures against pestiviral diseases: Bovine viral diarrhea, classical swine fever and border disease.

    PubMed

    Newcomer, Benjamin W; Givens, M Daniel

    2013-10-01

    The pestiviruses, bovine viral diarrhea virus (BVDV), classical swine fever (CSFV) and border disease virus, are important livestock pathogens in many countries, but current vaccines do not completely prevent the spread of infection. Control of pestiviral diseases is especially difficult due to the constant viremia and viral shedding of persistently infected (PI) animals, which must be identified and eliminated to prevent disease transmission. Existing vaccines are limited by the delay between vaccination and the onset of protection, the difficulty of differentiating serologically between vaccinated and naturally infected animals and the need for broad vaccine cross-protection against diverse virus strains. Antiviral therapy could potentially supplement vaccination by providing immediate protection in the case of an outbreak. Numerous compounds with in vitro antiviral activity against BVDV have been identified through its role as a surrogate for hepatitis C virus. Fewer drugs active against CSFV have been identified, but many compounds that are effective against BVDV will likely inhibit CSFV, given their similar genomic sequences. While in vitro research has been promising, the paucity of efficacy studies in animals has hindered the commercial development of effective antiviral drugs against the pestiviruses. In this article, we summarize the clinical syndromes and routes of transmission of BVD, CSF and border disease, discuss currently approved vaccines, review efforts to develop antiviral therapies for use in outbreak control and suggest promising directions for future research.

  11. Supplementation in the Columbia Basin : Summary Report Series : Final Report.

    SciTech Connect

    United States. Bonneville Power Administration.

    1992-12-01

    of Supplementation Project (RASP) was initiated as a result of a request by NPPC to address long-standing concerns about the need to coordinate supplementation research, monitoring and evaluation. Such coordination was also recommended by the Supplementation Technical Work Group. In August 1990, the NPPC gave conditional approval to proceed with the final design of the Yakima Production Project. The Council called on the Bonneville Power Administration (BPA) to fund immediately a supplementation assessment to reevaluate, prioritize and coordinate all existing and planned supplementation monitoring and evaluation activities in the basin. Providing for the participation of the fishery agencies and tribes and others having expertise in this area. RASP addresses four principal objectives: (1) provide an overview of ongoing and planned supplementation activities and identify critical uncertainties associated with supplementation, (2) construct a conceptual framework and model which estimates the potential benefits and risks of supplementation and prioritizes uncertainties, (3) provide guidelines for the development of supplementation projects, (4) develop a plan for regional coordination of research and monitoring. These objectives, once attained, will provide the technical tools fishery managers need to carry out the Council's direction to protect and enhance salmon and steelhead. RASP has further divided the four broad objectives into 12 technical topics: (1) definition of supplementation; (2) description of the diversity of supplementation projects; (3) objectives and performance standards; (4) identification of uncertainties; (5) supplementation theory; (6) development of a conceptual model of supplemented populations; (7) development of spreadsheet model of risks and benefits of supplementation; (8) classification of stocks, streams, and supplementation strategies; (9) regional design of supplementation evaluation and monitoring; (10) guidelines for planning

  12. Senate approves energy bill

    NASA Astrophysics Data System (ADS)

    Bush, Susan

    The controversial National Energy Security Act of 1992 (S2166) was approved by the Senate in a 94-4 vote on February 19 after a circuitous route through the chamber. The original energy bill, SI220, was introduced last summer and was blocked from coming to the Senate floor by a filibuster. The new bill is considerably different from the original energy bill.The sponsor of the bill, S. Bennett Johnston (D-La.), and cosponsor Malcolm Wallop (R-Wyo.) agreed to abandon certain controversial components in order to keep the bill moving. The main program dropped is the proposal to open parts of the Arctic National Wildlife Refuge (ANWR) to oil and gas drilling. Environmentalists were opposed to the drilling and were able to block the entire bill last fall, so Johnston agreed to abandon the provision.

  13. Development of Safe and Effective Botanical Dietary Supplements

    PubMed Central

    2015-01-01

    Regulated differently than drugs or foods, the market for botanical dietary supplements continues to grow worldwide. The recently implemented U.S. FDA regulation that all botanical dietary supplements must be produced using good manufacturing practice is an important step toward enhancing the safety of these products, but additional safeguards could be implemented, and unlike drugs, there are currently no efficacy requirements. To ensure a safe and effective product, botanical dietary supplements should be developed in a manner analogous to pharmaceuticals that involves identification of mechanisms of action and active constituents, chemical standardization based on the active compounds, biological standardization based on pharmacological activity, preclinical evaluation of toxicity and potential for drug–botanical interactions, metabolism of active compounds, and finally, clinical studies of safety and efficacy. Completing these steps will enable the translation of botanicals from the field to safe human use as dietary supplements. PMID:26125082

  14. Development of Safe and Effective Botanical Dietary Supplements.

    PubMed

    van Breemen, Richard B

    2015-11-12

    Regulated differently than drugs or foods, the market for botanical dietary supplements continues to grow worldwide. The recently implemented U.S. FDA regulation that all botanical dietary supplements must be produced using good manufacturing practice is an important step toward enhancing the safety of these products, but additional safeguards could be implemented, and unlike drugs, there are currently no efficacy requirements. To ensure a safe and effective product, botanical dietary supplements should be developed in a manner analogous to pharmaceuticals that involves identification of mechanisms of action and active constituents, chemical standardization based on the active compounds, biological standardization based on pharmacological activity, preclinical evaluation of toxicity and potential for drug-botanical interactions, metabolism of active compounds, and finally, clinical studies of safety and efficacy. Completing these steps will enable the translation of botanicals from the field to safe human use as dietary supplements.

  15. Dietary supplement research portfolio at the NIH, 2009-2011.

    PubMed

    Garcia-Cazarin, Mary L; Wambogo, Edwina A; Regan, Karen S; Davis, Cindy D

    2014-04-01

    The U.S. dietary supplement market increased by 7.5% in 2012 compared with 2011, reaching $32.5 billion in sales. Therefore, federally supported research on dietary supplements is important to determine their health effects, safety, and efficacy. A portfolio analysis was performed across the NIH and the Office of Dietary Supplements (ODS) for fiscal years (FYs) 2009-2011 by using the databases Human Nutrition Research Information Management (HNRIM) and Computer Access to Research on Dietary Supplements (CARDS). The results indicated that total NIH dietary supplement-related funding for FYs 2009-2011 was $855 million ($295 million in 2009, $311 million in 2010, and $249 million in 2011). The institutes and centers with the highest investment in dietary supplement research were as follows: the National Heart, Lung, and Blood Institute ($135 million); the National Cancer Institute ($188 million); the National Center for Complementary and Alternative Medicine ($99 million); the National Institute of Diabetes and Digestive and Kidney Diseases ($68 million); the National Institute of Environmental Health Sciences ($58 million); and the ODS ($32 million). The dietary supplement ingredients receiving the most funding were botanicals (22%), vitamins (20%), lipids (14%), and minerals and trace elements (10%). The top 3 outcome research areas were cancer (61% of total dietary supplement investment), cardiovascular disease (47%), and women's reproductive health (38%). In FYs 2009, 2010, and 2011, the ODS provided 3.5%, 3.6%, and 4.1%, respectively, of the NIH investment in dietary supplement research. ODS funding focused on cellular, enzymatic, or molecular mechanisms (64% of total ODS funding). This portfolio analysis demonstrates that the NIH has committed substantial funding to dietary supplement research in an effort to expand the scientific knowledge base on the efficacy and safety of dietary supplements.

  16. The Evolution of Approval Services.

    ERIC Educational Resources Information Center

    Warzala, Martin

    1994-01-01

    Describes major developments in book approval plans used by academic libraries for acquisition and for information dissemination and document distribution services based on approval-like concepts. Topics addressed include publishers; marketing; the impact of library automation; value-added services; the economic climate; the influence of…

  17. Approval Plans. SPEC Kit 141.

    ERIC Educational Resources Information Center

    Howard, Clinton

    This SPEC kit is based on a June 1987 survey of approval plan use by 94 members of the Association of Research Libraries. It reports on the current practices of these libraries, the perceived advantages and disadvantages of using approval plans, and the effect of increased library materials costs and library automation on such plans. It is noted…

  18. 77 FR 52258 - Defense Federal Acquisition Regulation Supplement; DoD Voucher Processing (DFARS Case 2011-D054)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-29

    ... Regulation Supplement; DoD Voucher Processing (DFARS Case 2011-D054) AGENCY: Defense Acquisition Regulations... process. Interim vouchers that are selected using sampling methodologies will be reviewed and approved by... that are selected using sampling methodologies will be reviewed and approved by the contract auditors...

  19. β-Alanine supplementation and military performance.

    PubMed

    Hoffman, Jay R; Stout, Jeffrey R; Harris, Roger C; Moran, Daniel S

    2015-12-01

    During sustained high-intensity military training or simulated combat exercises, significant decreases in physical performance measures are often seen. The use of dietary supplements is becoming increasingly popular among military personnel, with more than half of the US soldiers deployed or garrisoned reported to using dietary supplements. β-Alanine is a popular supplement used primarily by strength and power athletes to enhance performance, as well as training aimed at improving muscle growth, strength and power. However, there is limited research examining the efficacy of β-alanine in soldiers conducting operationally relevant tasks. The gains brought about by β-alanine use by selected competitive athletes appears to be relevant also for certain physiological demands common to military personnel during part of their training program. Medical and health personnel within the military are expected to extrapolate and implement relevant knowledge and doctrine from research performed on other population groups. The evidence supporting the use of β-alanine in competitive and recreational athletic populations suggests that similar benefits would also be observed among tactical athletes. However, recent studies in military personnel have provided direct evidence supporting the use of β-alanine supplementation for enhancing combat-specific performance. This appears to be most relevant for high-intensity activities lasting 60-300 s. Further, limited evidence has recently been presented suggesting that β-alanine supplementation may enhance cognitive function and promote resiliency during highly stressful situations.

  20. 78 FR 20856 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Redesignation of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ...EPA is issuing a supplement to its proposed approval of the State of Indiana's request to redesignate the Indianapolis area to attainment for the 1997 annual National Ambient Air Quality Standards (NAAQS or standard) for fine particulate matter (PM2.5). This supplemental proposal revises and expands the basis for proposing approval of the state's request, in light of developments since EPA issued its initial proposal on September 27, 2011. This supplemental proposal addresses four issues, including the effects of two decisions of the United States Court of Appeals for the District of Columbia (D.C. Circuit or Court): the Court's August 21, 2012 decision to vacate and remand to EPA the Cross- State Air Pollution Control Rule (CSAPR) and the Court's January 4, 2013 decision to remand to EPA two final rules implementing the 1997 PM2.5 standard. In this supplemental proposal, EPA is also proposing to approve a supplement to the emission inventories previously submitted by the state. EPA is proposing that the inventories for ammonia and Volatile Organic Compounds (VOC), in conjunction with the inventories for nitrogen oxides (NOX), direct PM2.5, and sulfur dioxide (SO2) that EPA previously proposed to approve, meet the comprehensive emissions inventory requirement of the Clean Air Act (CAA). Finally, this supplemental proposal solicits comment on the state's January 17, 2013 submission of Motor Vehicle Emissions Budgets (MVEBs) developed using EPA's Motor Vehicle Emissions Simulator (MOVES) 2010a emissions model to replace the MOBILE6.2 based MVEBs previously submitted as part of the PM2.5 maintenance plan for the Indianapolis area. EPA is seeking comment only on the issues raised in its supplemental proposal, and is not re-opening for comment other issues raised in its prior proposal.

  1. Integrating dietary supplements into cancer care.

    PubMed

    Frenkel, Moshe; Abrams, Donald I; Ladas, Elena J; Deng, Gary; Hardy, Mary; Capodice, Jillian L; Winegardner, Mary F; Gubili, J K; Yeung, K Simon; Kussmann, Heidi; Block, Keith I

    2013-09-01

    Many studies confirm that a majority of patients undergoing cancer therapy use self-selected forms of complementary therapies, mainly dietary supplements. Unfortunately, patients often do not report their use of supplements to their providers. The failure of physicians to communicate effectively with patients on this use may result in a loss of trust within the therapeutic relationship and in the selection by patients of harmful, useless, or ineffective and costly nonconventional therapies when effective integrative interventions may exist. Poor communication may also lead to diminishment of patient autonomy and self-efficacy and thereby interfere with the healing response. To be open to the patient's perspective, and sensitive to his or her need for autonomy and empowerment, physicians may need a shift in their own perspectives. Perhaps the optimal approach is to discuss both the facts and the uncertainty with the patient, in order to reach a mutually informed decision. Today's informed patients truly value physicians who appreciate them as equal participants in making their own health care choices. To reach a mutually informed decision about the use of these supplements, the Clinical Practice Committee of The Society of Integrative Oncology undertook the challenge of providing basic information to physicians who wish to discuss these issues with their patients. A list of leading supplements that have the best suggestions of benefit was constructed by leading researchers and clinicians who have experience in using these supplements. This list includes curcumin, glutamine, vitamin D, Maitake mushrooms, fish oil, green tea, milk thistle, Astragalus, melatonin, and probiotics. The list includes basic information on each supplement, such as evidence on effectiveness and clinical trials, adverse effects, and interactions with medications. The information was constructed to provide an up-to-date base of knowledge, so that physicians and other health care providers would

  2. Family Living Supplement.

    ERIC Educational Resources Information Center

    Truitt, Debbie

    This family living supplement contains 125 supplemental ideas and strategies designed to help vocational home economics teachers increase student motivation and enrich the teaching process. Ideas and strategies are organized into seven sections. These are career planning, securing a job, and career success; managing financial resources, buying…

  3. Using Dietary Supplements Wisely

    MedlinePlus

    ... you to take. If you experience any side effects that concern you, stop taking the dietary supplement, and contact your health care provider. You can report serious problems suspected with dietary supplements to the U.S. Food and Drug Administration and the National Institutes of ...

  4. Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated?

    PubMed

    Wallace, Taylor C

    2015-08-01

    The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines the FDA's statutory authority to regulate dietary supplement products in the United States. The dietary supplement industry has rapidly expanded since 1994, presenting an obvious need for "DSHEA 2.0." Current regulations surrounding dietary supplements have been increasingly and reasonably scrutinized, given their widespread use by over one-half of the US population as well as highly publicized safety concerns over the past 20 y. As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting. © 2015 American Society for Nutrition.

  5. A phase II study with antioxidants, both in the diet and supplemented, pharmaconutritional support, progestagen, and anti-cyclooxygenase-2 showing efficacy and safety in patients with cancer-related anorexia/cachexia and oxidative stress.

    PubMed

    Mantovani, Giovanni; Macciò, Antonio; Madeddu, Clelia; Gramignano, Giulia; Lusso, Maria Rita; Serpe, Roberto; Massa, Elena; Astara, Giorgio; Deiana, Laura

    2006-05-01

    To test the efficacy and safety of an integrated treatment based on a pharmaconutritional support, antioxidants, and drugs, all given orally, in a population of advanced cancer patients with cancer-related anorexia/cachexia and oxidative stress. An open early-phase II study was designed according to the Simon two-stage design. The integrated treatment consisted of diet with high polyphenols content (400 mg), antioxidant treatment (300 mg/d alpha-lipoic acid + 2.7 g/d carbocysteine lysine salt + 400 mg/d vitamin E + 30,000 IU/d vitamin A + 500 mg/d vitamin C), and pharmaconutritional support enriched with 2 cans per day (n-3)-PUFA (eicosapentaenoic acid and docosahexaenoic acid), 500 mg/d medroxyprogesterone acetate, and 200 mg/d selective cyclooxygenase-2 inhibitor celecoxib. The treatment duration was 4 months. The following variables were evaluated: (a) clinical (Eastern Cooperative Oncology Group performance status); (b) nutritional [lean body mass (LBM), appetite, and resting energy expenditure]; (c) laboratory [proinflammatory cytokines and leptin, reactive oxygen species (ROS) and antioxidant enzymes]; (d) quality of life (European Organization for Research and Treatment of Cancer QLQ-C30, Euro QL-5D, and MFSI-SF). From July 2002 to January 2005, 44 patients were enrolled. Of these, 39 completed the treatment and were assessable. Body weight increased significantly from baseline as did LBM and appetite. There was an important decrease of proinflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor-alpha, and a negative relationship worthy of note was only found between LBM and IL-6 changes. As for quality of life evaluation, there was a marked improvement in the European Organization for Research and Treatment of Cancer QLQ-C30, Euro QL-5D(VAS), and multidimensional fatigue symptom inventory-short form scores. At the end of the study, 22 of the 39 patients were "responders" or "high responders." The minimum required was 21; therefore, the

  6. The use of, and perceptions about, dietary supplements among patients with heart failure.

    PubMed

    Fan, Xiuzhen; Lee, Kyoung Suk; Frazier, Susan K; Lennie, Terry A; Moser, Debra K

    2014-08-01

    Dietary supplement use is widespread; patterns of use and perceptions about supplements in individuals with heart failure (HF) are not well understood. The purpose of this study was to describe the prevalence, patterns and reasons for use of dietary supplements, and to compare characteristics of, and perceptions about, safety and efficacy between dietary supplement user and non-user participants with HF. Patients with HF (n=99) completed a Dietary Supplement Questionnaire. Descriptive statistics were used to analyze the data. Independent sample t-tests, Fisher's exact test, and Chi square analyses compared dietary supplement users to non-users. More than half of the participants used at least one dietary supplement and almost all patients using dietary supplements reported they had informed their healthcare provider. Dietary supplements were taken to improve intake of dietary components and better individual health state. Participants thought that dietary supplements in general were safer and more effective than current evidence suggests. Users and non-users expressed similar perceptions. Patients who used dietary supplements were older (64±10 years vs 53±12 years) and had a lower body mass index (30.0±6.5 kg/m(2) vs 34.1±8.3 kg/m(2)) compared with patients who did not. Dietary supplement use was common in these participants with HF; global perceptions about safety and efficacy of dietary supplements were similar between users and non-users of dietary supplements. Systematic evaluation of dietary supplement use, with discussion about safety and efficacy may be constructive for patients with HF. © The European Society of Cardiology 2013.

  7. Dietary supplements and team-sport performance.

    PubMed

    Bishop, David

    2010-12-01

    highlighted in this review needs to be conducted using team-sport athletes and using team-sport-relevant testing (e.g. single- and multiple-sprint performance). It should also be considered that there is no guarantee that dietary supplements that improve isolated performance (i.e. single-sprint or jump performance) will remain effective in the context of a team-sport match. Thus, more research is also required to investigate the effects of dietary supplements on simulated or actual team-sport performance. A second aim of this review was to investigate any health issues associated with the ingestion of the more commonly promoted dietary supplements. While most of the supplements described in the review appear safe when using the recommended dose, the effects of higher doses (as often taken by athletes) on indices of health remain unknown, and further research is warranted. Finally, anecdotal reports suggest that team-sport athletes often ingest more than one dietary supplement and very little is known about the potential adverse effects of ingesting multiple supplements. Supplements that have been demonstrated to be safe and efficacious when ingested on their own may have adverse effects when combined with other supplements. More research is required to investigate the effects of ingesting multiple supplements (both on performance and health).

  8. Fatty acid and phytosterol content of commercial saw palmetto supplements.

    PubMed

    Penugonda, Kavitha; Lindshield, Brian L

    2013-09-13

    Saw palmetto supplements are one of the most commonly consumed supplements by men with prostate cancer and/or benign prostatic hyperplasia (BPH). Some studies have found significant improvements in BPH and lower urinary tract symptoms (LUTS) with saw palmetto supplementation, whereas others found no benefits. The variation in the efficacy in these trials may be a result of differences in the putative active components, fatty acids and phytosterols, of the saw palmetto supplements. To this end, we quantified the major fatty acids (laurate, myristate, palmitate, stearate, oleate, linoleate) and phytosterols (campesterol, stigmasterol, β-sitosterol) in 20 commercially available saw palmetto supplements using GC-FID and GC-MS, respectively. Samples were classified into liquids, powders, dried berries, and tinctures. Liquid saw palmetto supplements contained significantly higher (p < 0.05) concentrations of total fatty acids (908.5 mg/g), individual fatty acids, total phytosterols (2.04 mg/g), and individual phytosterols, than the other supplement categories. Powders contained significantly higher (p < 0.05) concentrations of total fatty acids than tinctures, which contain negligible amounts of fatty acids (46.3 mg/g) and phytosterols (0.10 mg/g). Our findings suggest that liquid saw palmetto supplements may be the best choice for individuals who want to take a saw palmetto supplement with the highest concentrations of both fatty acids and phytosterols.

  9. Fatty Acid and Phytosterol Content of Commercial Saw Palmetto Supplements

    PubMed Central

    Penugonda, Kavitha; Lindshield, Brian L.

    2013-01-01

    Saw palmetto supplements are one of the most commonly consumed supplements by men with prostate cancer and/or benign prostatic hyperplasia (BPH). Some studies have found significant improvements in BPH and lower urinary tract symptoms (LUTS) with saw palmetto supplementation, whereas others found no benefits. The variation in the efficacy in these trials may be a result of differences in the putative active components, fatty acids and phytosterols, of the saw palmetto supplements. To this end, we quantified the major fatty acids (laurate, myristate, palmitate, stearate, oleate, linoleate) and phytosterols (campesterol, stigmasterol, β-sitosterol) in 20 commercially available saw palmetto supplements using GC-FID and GC-MS, respectively. Samples were classified into liquids, powders, dried berries, and tinctures. Liquid saw palmetto supplements contained significantly higher (p < 0.05) concentrations of total fatty acids (908.5 mg/g), individual fatty acids, total phytosterols (2.04 mg/g), and individual phytosterols, than the other supplement categories. Powders contained significantly higher (p < 0.05) concentrations of total fatty acids than tinctures, which contain negligible amounts of fatty acids (46.3 mg/g) and phytosterols (0.10 mg/g). Our findings suggest that liquid saw palmetto supplements may be the best choice for individuals who want to take a saw palmetto supplement with the highest concentrations of both fatty acids and phytosterols. PMID:24067389

  10. VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health

    PubMed Central

    Allen, Katrina J; Panjari, Mary; Koplin, Jennifer J; Ponsonby, Anne-Louise; Vuillermin, Peter; Gurrin, Lyle C; Greaves, Ronda; Carvalho, Natalie; Dalziel, Kim; Tang, Mimi L K; Lee, Katherine J; Wake, Melissa; Curtis, Nigel; Dharmage, Shyamali C

    2015-01-01

    Introduction Postnatal vitamin D supplementation may be associated with a reduction in IgE-mediated food allergy, lower respiratory tract infections and improved bone health. Countries in the Northern hemisphere recommend universal infant vitamin D supplementation to optimise early vitamin D levels, despite the absence of large trials proving safety or efficacy for any disease outcome. With the aim of determining the clinical and cost-effectiveness of daily vitamin D supplementation in breastfed infants from age 6–8 weeks to 12 months of age, we have started a double-blind, randomised, placebo-controlled trial of daily 400 IU vitamin D supplementation during the first year of life, VITALITY. Methods nd analysis Infants (n=3012) who are fully breastfed and not receiving vitamin D supplementation will be recruited at the time of their first immunisation, from council-led immunisation clinics throughout metropolitan Melbourne, Australia. The primary outcome is challenge-proven food allergy at 12 months of age. Secondary outcomes are food sensitisation (positive skin prick test), number of lower respiratory infections (through hospital linkage), moderately-severe and persistent eczema (by history and examination) and vitamin D deficiency (serum vitamin D <50 nmol/L) at age 12 months. The trial is underway and the first 130 participants have been recruited. Ethics and dissemination The VITALITY study is approved by the Royal Children's Hospital (RCH) Human Research Ethics Committee (#34168). Outcomes will be disseminated through publication and will be presented at scientific conferences. Trial registration numbers ANZCTR12614000334606 and NCT02112734; pre-results. PMID:26674499

  11. Supplemental instruction in chemistry

    NASA Astrophysics Data System (ADS)

    Lundeberg, Mary A.

    This study was designed to measure some effects of supplemental instruction in chemistry. Supplemental instruction is a peer-led cooperative learning program that encourages students to develop conceptual understanding by articulating both understandings and misconceptions in a think-aloud fashion. Supplemental instruction was offered three hours weekly outside of class and lab time for students in four classes of General Organic and Biological Chemistry. Over a two-year period 108 students volunteered to participate in this program; 45 students did not participate. As measured by final grades in chemistry and responses to a questionnaire, supplemental instruction was effective in increasing students' achievement in chemistry. Further research is needed to determine the in-depth effects of supplemental instruction on students' learning, problem solving, and self-esteem.

  12. Efficacy of partially hydrolyzed guar gum (PHGG) supplemented modified oral rehydration solution in the treatment of severely malnourished children with watery diarrhoea: a randomised double-blind controlled trial.

    PubMed

    Alam, Nur Haque; Ashraf, Hasan; Kamruzzaman, Mohammad; Ahmed, Tahmeed; Islam, Sufia; Olesen, Maryam Kadjar; Gyr, Niklaus; Meier, Remy

    2015-05-01

    To examine whether PHGG added ORS reduce duration of diarrhoea, stool output and enhance weight gain. In a double-blind controlled clinical trial, 126 malnourished children (weight for length/weight for age < -3 Z-score with or without pedal edema), aged 6 - 36 months with acute diarrhoea <7 days were studied in two treatment groups; 63 received modified WHO ORS (Na 75, K 40, Cl 87, citrate 7, glucose 90 mmol/L) with PHGG 15 g/L (study group); 63 received modified WHO ORS without PHGG (control). Other treatments were similar in both groups. The study protocol was approved by Ethics Committee of icddr,b; the study was carried out at the Dhaka Hospital. The mean duration of diarrhoea (h) was significantly shorter in children of the study group (Study vs. control, mean ± SD, 57 ± 31 vs. 75 ± 39, p = 0.01). Although there was a trend in stool weight reduction in children receiving ORS with PHGG (study vs. control, stool weight (g), mean ± SD; 1(st) 24 hour, 854.03 ± 532.15 vs. 949.11 ± 544.33, p = 0.32; 2(nd) 24 hour, 579.84 ± 466.01 vs. 761.26 ± 631.64, p = 0.069; 3(rd) 24 hour, 385.87 ± 454.09 vs. 495.73 ± 487.61, p = 0.196), especially in 2(nd) 24 h period, the difference was not statistically significant. The mean time (day) to attain weight for length 80% of NCHS median without edema was significantly shorter in the study group (study vs. control, mean ± SD, 4.5 ± 2.6 vs. 5.7 ± 2.8, p = 0.027). PHGG added to ORS substantially reduced duration of diarrhoea. It also enhanced weight gain. Further studies might substantiate to establish its beneficial effect. NCT01821586.

  13. 76 FR 30738 - Agency Information Collection Activities: Form G-845 and Form G-845 Supplement, Revision of a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

    ... SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form G-845 and Form G- 845 Supplement, Revision of a Currently Approved Information Collection; Comment Request ACTION: 30-Day Notice of Information Collection under Review: Form G- 845 and Form G-845 Supplement, Document...

  14. 75 FR 29779 - Agency Information Collection Activities: Form I-918, Extension of a Currently Approved...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-27

    ... SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form I-918, Extension of a Currently Approved Information Collection; Comment Request ACTION: 30-Day Notice of Information Collection Under Review: Form I- 918, Petition for U Nonimmigrant Status; and Supplement A and B...

  15. 78 FR 78411 - Consideration of Approval of Transfer of Renewed Facility Operating Licenses, Materials Licenses...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ...) received and is considering approval of an application filed by Constellation Energy Nuclear Group, LLC (Constellation) on August 6, 2013, as supplemented on August 14 and September 23, 2013. The application seeks NRC... from the current holder, Constellation, to Exelon Generation Company, LCC (Exelon). The facilities...

  16. 5 CFR 3601.107 - Prior approval for outside employment and business activities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... business activities. 3601.107 Section 3601.107 Administrative Personnel DEPARTMENT OF DEFENSE SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF DEFENSE § 3601.107 Prior approval for outside employment and business activities. (a) A DoD employee, other than a special Government employee...

  17. 20 CFR 416.1525 - Request for approval of a fee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Request for approval of a fee. 416.1525 Section 416.1525 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE... performed in dealings with us, he or she shall file a written request with one of our offices. This should...

  18. 76 FR 28971 - Atlanta Gas Light Company; Notice of Petition for Rate Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-19

    ... Federal Energy Regulatory Commission Atlanta Gas Light Company; Notice of Petition for Rate Approval Take notice that on May 9, 2011, as supplemented on May 11, 2011, Atlanta Gas Light Company (Atlanta Gas Light... for transportation service. Atlanta Gas Light states the rate election consists of the maximum...

  19. 77 FR 21453 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Revisions to New Source...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-10

    ...: EPA is approving those revisions adopted by the State of Colorado on April 16, 2004 to Regulation No... into the State Implementation Plan (SIP) on July 11, 2005 and supplemented its request on October 25...) construction permit programs of the State of Colorado. Other revisions, renumberings, additions, or deletions...

  20. 75 FR 38589 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-02

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of Accelerated Delivery of Supplement to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Options on...

  1. 78 FR 18973 - Bridgeline Holdings, L.P.; Notice of Petition for Rate Approval

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-28

    ... Energy Regulatory Commission Bridgeline Holdings, L.P.; Notice of Petition for Rate Approval Take notice that on February 28, 2013, as supplemented on March 12, 2013, Bridgeline Holdings, L.P. filed for... free). For TTY, call (202) 502-8659. Comment Date: 5:00 p.m. Eastern Time on Monday, April 1,...

  2. 78 FR 60704 - Approval and Promulgation of Air Quality Implementation Plan; Illinois; Redesignation of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-02

    ... Oxides (NO X ), Sulfur Dioxide (SO 2 ), Volatile Organic Compound (VOC), ammonia, and primary PM 2.5... supplemental submission to the EPA on May 6, 2013, the IEPA submitted VOC and ammonia emission inventories to... Chicago area; approve 2002 primary PM 2.5 , NO X , SO 2 , VOC, and ammonia emission inventories for the...

  3. 75 FR 30451 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-01

    ... COMMISSION Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of Accelerated Delivery of Supplement to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Options on Conventional Index-Linked Securities and Amendment to the Options Disclosure Document...

  4. 77 FR 3828 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... COMMISSION Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of Accelerated Delivery of Supplement to the Options Disclosure Document Reflecting Certain Changes to Disclosure... to amend the options disclosure document (``ODD'') to reflect certain changes to disclosure regarding...

  5. 76 FR 19173 - Self-Regulatory Organizations; the Options Clearing Corporation; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-06

    ... COMMISSION Self-Regulatory Organizations; the Options Clearing Corporation; Order Granting Approval of Accelerated Delivery of Supplement to the Options Disclosure Document Reflecting Certain Changes to Disclosure... Disclosure Document Inside Front Cover March 31, 2011. On May 21, 2010, the Options Clearing Corporation...

  6. 42 CFR 403.222 - State with an approved regulatory program.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 2 2011-10-01 2011-10-01 false State with an approved regulatory program. 403.222 Section 403.222 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS SPECIAL PROGRAMS AND PROJECTS Medicare Supplemental Policies State Regulatory...

  7. 76 FR 3684 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of Accelerated Delivery of Supplement to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Credit Default Options in,...

  8. 5 CFR 4501.103 - Prior approval for certain outside activities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for certain outside activities. 4501.103 Section 4501.103 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OFFICE OF PERSONNEL MANAGEMENT § 4501.103 Prior...

  9. Calcium supplements and cardiovascular risk: 5 years on.

    PubMed

    Bolland, Mark J; Grey, Andrew; Reid, Ian R

    2013-10-01

    Calcium supplements have been widely used by older men and women. However, in little more than a decade, authoritative recommendations have changed from encouraging the widespread use of calcium supplements to stating that they should not be used for primary prevention of fractures. This substantial shift in recommendations has occurred as a result of accumulated evidence of marginal antifracture efficacy, and important adverse effects from large randomized controlled trials of calcium or coadministered calcium and vitamin D supplements. In this review, we discuss this evidence, with a particular focus on increased cardiovascular risk with calcium supplements, which we first described 5 years ago. Calcium supplements with or without vitamin D marginally reduce total fractures but do not prevent hip fractures in community-dwelling individuals. They also cause kidney stones, acute gastrointestinal events, and increase the risk of myocardial infarction and stroke. Any benefit of calcium supplements on preventing fracture is outweighed by increased cardiovascular events. While there is little evidence to suggest that dietary calcium intake is associated with cardiovascular risk, there is also little evidence that it is associated with fracture risk. Therefore, for the majority of people, dietary calcium intake does not require close scrutiny. Because of the unfavorable risk/benefit profile, widespread prescribing of calcium supplements to prevent fractures should be abandoned. Patients at high risk of fracture should be encouraged to take agents with proven efficacy in preventing vertebral and nonvertebral fractures.

  10. Supplements for Diabetes Mellitus: A Review of the Literature.

    PubMed

    Yilmaz, Zera; Piracha, Fawad; Anderson, Leeann; Mazzola, Nissa

    2016-09-11

    The primary approach to controlling diabetes involves diet and lifestyle modification combined with pharmacologic interventions. Patients who are interested in exploring dietary supplements in the management of diabetes may have questions about which supplement to choose and whether any issues will arise with their current medication regimen. After reading this review, the pharmacist should be able to identify supplements that may provide benefit to improve diabetes management, understand what potential harm to the patient may occur, and be able to assist the patient in choosing high-quality supplements. This review will focus on the safety and efficacy data surrounding nicotinamide, ginseng, fenugreek, vitamin D, chromium, and cinnamon. These supplements are commonly listed in general circulation periodicals with claims to improve blood sugar management. Efficacy data showed a modest decrease in fasting plasma glucose of -0.96 mmol/dL (-17.29 mg/dL) for fenugreek and -24.59 mg/dL for cinnamon. It remains to be seen whether supplementation with these products can affect outcomes such as morbidity and mortality. Despite many studies being available, the majority lack uniformity across multiple dimensions, including varying participant characteristics, inconsistent formulations of supplement and dose, and differing study durations. This, coupled with variation in quality and purity of commercially available products, prevents universal recommendation for use in diabetes management.

  11. Will iron supplementation given during menstruation improve iron status better than weekly supplementation?

    PubMed

    Februhartanty, Judhiastuty; Dillon, Drupadi; Khusun, Helda

    2002-01-01

    To investigate the efficacy of two different iron supplements administered either on a weekly basis or during menstruation, a 16-week community experimental study was carried out among postmenarcheal female adolescent students in Kupang, East Nusa Tenggara, Indonesia. Forty eight students received a placebo tablet weekly, 48 other students got an iron tablet weekly and 41 students took an iron tablet for four consecutive days during their menstruation cycle. All subjects were given deworming tablets before supplementation. Haemoglobin, serum ferritin, height, weight, mid-upper arm circumference and dietary intake were assessed before and after intervention. The supplementation contributed to a significant improvement in the iron status of the intervention groups compared to the placebo group (P < 0.05). In the menstruation group, the haemoglobin concentrations of the anaemic subjects improved significantly (P < 0.05) while for the non-anaemic subjects, serum ferritin concentrations also increased significantly (P < 0.05). In the weekly group for anaemic and nonanaemic subjects, there was a significant increase in both haemoglobin and serum ferritin concentrations (P < 0.05). This study revealed that weekly supplementation of iron tablets continued for 16 weeks contributed a higher improvement to haemoglobin concentration, compared with supplementing iron tablets for four consecutive days during menstruation for four menstrual cycles. This suggests that weekly iron supplementation is preferable.

  12. 40 CFR 52.2772 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Virgin Islands § 52.2772 Approval status. With the exceptions set forth in this subpart, the Administrator approves the U.S. Virgin Islands plan...

  13. 40 CFR 52.2772 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Virgin Islands § 52.2772 Approval status. With the exceptions set forth in this subpart, the Administrator approves the U.S. Virgin Islands plan...

  14. 40 CFR 52.2772 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Virgin Islands § 52.2772 Approval status. With the exceptions set forth in this subpart, the Administrator approves the U.S. Virgin Islands plan...

  15. 40 CFR 52.1972 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1972 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oregon's plan for the attainment...

  16. 40 CFR 52.1972 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1972 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oregon's plan for the attainment...

  17. 40 CFR 52.1972 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1972 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oregon's plan for the attainment...

  18. 40 CFR 52.1972 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1972 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oregon's plan for the attainment...

  19. Drugs Approved for Soft Tissue Sarcoma

    MedlinePlus

    ... Your Treatment Research Drugs Approved for Soft Tissue Sarcoma This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Soft Tissue Sarcoma Cosmegen (Dactinomycin) Dactinomycin Doxorubicin Hydrochloride Eribulin Mesylate Gleevec ( ...

  20. 40 CFR 52.2172 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) South Dakota § 52.2172 Approval status. With the exceptions set forth in this subpart, the Administrator approves South Dakota's plan as meeting...

  1. 40 CFR 52.1822 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Dakota § 52.1822 Approval status. With the exceptions set forth in this subpart, the Administrator approves the North Dakota plan for the...

  2. 40 CFR 52.1822 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Dakota § 52.1822 Approval status. With the exceptions set forth in this subpart, the Administrator approves the North Dakota plan for the...

  3. 40 CFR 52.1822 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Dakota § 52.1822 Approval status. With the exceptions set forth in this subpart, the Administrator approves the North Dakota plan for the...

  4. 40 CFR 52.1822 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Dakota § 52.1822 Approval status. With the exceptions set forth in this subpart, the Administrator approves the North Dakota plan for the...

  5. 40 CFR 52.1822 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Dakota § 52.1822 Approval status. With the exceptions set forth in this subpart, the Administrator approves the North Dakota plan for the...

  6. 40 CFR 52.2722 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Puerto Rico § 52.2722 Approval status. With the exceptions set forth in this subpart, the Administrator approves Puerto Rico's plans for the...

  7. 46 CFR 170.093 - Specific approvals.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Marine Safety Center. These approval determinations will be made as a part of the plan review process. ... REQUIREMENTS FOR ALL INSPECTED VESSELS Plan Approval § 170.093 Specific approvals. Certain rules in...

  8. 30 CFR 7.29 - Approval marking.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... approval number at intervals not exceeding ten feet. If the nature of the material or method of processing... section with the assigned MSHA approval number. (c) An approved product shall be marketed only under a...

  9. 40 CFR 52.2372 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Vermont § 52.2372 Approval status. With the exceptions set forth in this subpart, the Administrator approves Vermont's plan as identified in § 52.2370...

  10. 40 CFR 52.2372 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Vermont § 52.2372 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Vermont's plan as identified in...

  11. 40 CFR 52.2372 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Vermont § 52.2372 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Vermont's plan as identified in...

  12. 40 CFR 52.1522 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Hampshire § 52.1522 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves New Hampshire's plan as...

  13. 40 CFR 52.1573 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Jersey § 52.1573 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Jersey's plans for...

  14. 40 CFR 52.1573 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Jersey § 52.1573 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Jersey's plans for...

  15. 40 CFR 52.1873 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Ohio § 52.1873 Approval status. With the exceptions set forth in this subpart the Administrator approves Ohio's plan for the attainment...

  16. 40 CFR 52.1272 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Mississippi § 52.1272 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Mississippi's plan for...

  17. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment and...

  18. 40 CFR 52.1472 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Nevada § 52.1472 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Nevada's plan for the...

  19. 40 CFR 52.1472 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Nevada § 52.1472 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Nevada's plan for the...

  20. 40 CFR 52.1472 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Nevada § 52.1472 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Nevada's plan for the...