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Sample records for efficacy supplement approvals

  1. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review

    PubMed Central

    Wang, Bo

    2015-01-01

    Objective To characterize the types of comparators and endpoints used in efficacy trials for approvals of supplemental indications, compared with the data supporting these drugs’ originally approved indications. Design Systematic review. Setting Publicly accessible data on supplemental indications approved by the US Food and Drug Administration from 2005 to 2014. Main outcome measures Types of comparators (active, placebo, historical, none) and endpoints (clinical outcomes, clinical scales, surrogate) in the efficacy trials for these drugs’ supplemental and original indication approvals. Results The cohort included 295 supplemental indications. Thirty per cent (41/136) of supplemental approvals for new indications were supported by efficacy trials with active comparators, compared with 51% (47/93) of modified use approvals and 11% (7/65) of approvals expanding the patient population (P<0.001), almost all of which related to pediatric patients (61/65; 94%). Trials using clinical outcome endpoints led to approval for 32% (44/137) of supplemental approvals for new indications, 30% (28/93) of modified indication approvals, and 22% (14/65) of expanded population approvals (P=0.29). Orphan drugs had supplemental approvals for 40 non-orphan indications, which were supported by similar proportions of trials using active comparators (28% (11/40) for non-orphan supplemental indications versus 24% (10/42) for original orphan indications; P=0.70) and clinical outcome endpoints (25% (10/40) versus 31% (13/42); P=0.55). Conclusions Wide variations were seen in the evidence supporting approval of supplemental indications, with the fewest active comparators and clinical outcome endpoints used in trials leading to supplemental approvals that expanded the patient population. PMID:26400844

  2. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Approval of supplemental applications. 514.106 Section 514.106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUG APPLICATIONS Administrative Actions on Applications § 514.106 Approval...

  3. Supplements and other changes to an approved application. Final rule.

    PubMed

    2004-04-01

    The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report. PMID:15072041

  4. FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012

    PubMed Central

    Rome, Benjamin N.; Kramer, Daniel B.; Kesselheim, Aaron S.

    2014-01-01

    IMPORTANCE The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via “supplements,” which may not require additional clinical testing. OBJECTIVE To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. DESIGN Using the FDA’s PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories overtime. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. RESULTS From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device’s design. Among 180-day supplements approved from 2010

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Review and approval of plan supplements. 1953.6 Section 1953.6 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) CHANGES TO STATE PLANS § 1953.6 Review and approval of plan supplements....

  6. 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... DRUG Applications § 314.71 Procedures for submission of a supplement to an approved application....

  7. 29 CFR 1953.6 - Review and approval of plan supplements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 9 2011-07-01 2011-07-01 false Review and approval of plan supplements. 1953.6 Section 1953.6 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) CHANGES TO STATE PLANS § 1953.6 Review and approval of plan supplements....

  8. 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

    ... Regulation Supplement: Approval of Rental Waiver Requests (DFARS Case 2013-D006) AGENCY: Defense Acquisition... officers to approve requests for waiver or reduction of rental charges for the use of Government property... extremely low dollar values over the rental period. Currently, DSCA is required to approve requests in...

  9. 76 FR 20435 - Notice of Approval of the Supplemental Finding of No Significant Impact and Record of Decision...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-12

    ... Supplemental Finding ] of No Significant Impact/Record of Decision (FONSI/ROD) for the Supplemental.... The Supplemental FONSI/ROD provides final agency determinations and approvals for the proposed...). SUPPLEMENTARY INFORMATION: The Supplemental FONSI/ROD is for the approval of actions for proposed changes to...

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

    PubMed

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

    2016-12-01

    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. PMID:25875654

  11. 21 CFR 314.97 - Supplements and other changes to an approved abbreviated application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Supplements and other changes to an approved abbreviated application. 314.97 Section 314.97 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...

  12. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... approved standards. (x) A change in an expiration date. (xi) Addition of an alternate...

  13. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... approved standards. (x) A change in an expiration date. (xi) Addition of an alternate...

  14. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... approved standards. (x) A change in an expiration date. (xi) Addition of an alternate...

  15. 21 CFR 514.106 - Approval of supplemental applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., storage, expiration dates, etc). (vi) A change in promotional material for a prescription new animal drug... approved standards. (x) A change in an expiration date. (xi) Addition of an alternate...

  16. Analysis of Selection Activities to Supplement Approval Plans.

    ERIC Educational Resources Information Center

    Loup, Jean L.; Snoke, Helen Lloyd

    1991-01-01

    Describes two surveys of libraries by the Association of Research Libraries (ARL) that were conducted to compare approval plans and to determine alternative acquisitions methods for materials in philosophy and political science. Time spent by selectors is examined, collection evaluation activities are described, and implications for resource…

  17. 78 FR 11808 - Approval and Promulgation of Implementation Plans; Tennessee: Approve Knox County Supplemental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... revised ozone National Ambient Air Quality Standards (NAAQS). See 73 FR 16436. The current action, however... Supplemental Motor Vehicle Emissions Budget Update AGENCY: Environmental Protection Agency (EPA). ACTION... revision proposes to increase the safety margin allocated to motor vehicle emissions budgets for...

  18. 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

    ...The Food and Drug Administration (FDA) is announcing the rate for the abbreviated new drug application (ANDA), prior approval supplement to an approved ANDA (PAS), drug master file (DMF), generic drug active pharmaceutical ingredient (API), and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2014. The Federal Food, Drug, and......

  19. 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. PMID:25900871

  20. 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…

  1. 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...

  2. 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

    ... of production or storage capacity; (4) Increase the emissions of an air pollutant to an amount that... 30 Mineral Resources 2 2011-07-01 2011-07-01 false When must I revise or supplement the approved EP, DPP, or DOCD? 250.283 Section 250.283 Mineral Resources BUREAU OF OCEAN ENERGY...

  3. Efficacy of a Botanical Supplement with Concentrated Echinacea purpurea for Increasing Aerobic Capacity

    PubMed Central

    Bellar, David; Moody, Kaitlyn M.; Richard, Nicholas S.; Judge, Lawrence W.

    2014-01-01

    The present investigation evaluated the efficacy of a botanical supplement that delivered a concentrated dose of Echinacea purpurea (8 grams day−1). The participants were 13 apparently healthy, recreationally active college students (VO2 max: 51 mL O2/kg∗min). The participants were provided with a 30-day supplementation regime. Data regarding maximum aerobic capacity was collected through pre- and posttesting surrounding the 30-day supplementation regime. The participants were instructed to maintain normal levels of physical activity and exercise during the experimental period. The levels of physical activity and exercise were monitored via the Leisure and Physical Activity Survey. The participants did not report any significant increases in aerobic physical activity or exercise during the supplementation period. Paired samples t-test analysis did not reveal a significant difference in maximum aerobic capacity, t(12) = 0.67, P = .516. Presupplementation maximum aerobic capacity (M = 51.0, SD = 6.8) was similar to postsupplementation values (M = 51.8, SD = 6.5). This study suggests that botanical supplements containing a concentrated dose of Echinacea purpurea is not an effective intervention to increase aerobic capacity of recreationally active individuals. PMID:24967264

  4. Efficacy of dietary aloe vera supplementation on hepatic cholesterol and oxidative status in aged rats.

    PubMed

    Lim, Beong Ou; Seong, Nak Sul; Choue, Ryo Won; Kim, Jong Dai; Lee, Hyeon Yong; Kim, Sun Yeou; Yu, Byung Pal; Jeon, Tae Il; Park, Dong Ki

    2003-08-01

    In the current study, we show the anti-oxidative and hypocholesterol effects of aloe vera in the liver. Male specific pathogen-free (SPF) Fischer 344 rats were randomly assigned to one of four groups: Group A (control) was fed test chow without aloe supplementation; Group B was fed a diet containing a 1% (per weight basis) freeze-dried aloe filet; Group C was fed a diet containing a 1% (per weight basis) charcoal-processed, freeze-dried aloe filet; and Group D was fed a diet containing a charcoal-processed freeze-dried, whole leaf aloe (0.02% per weight basis) in the drinking water. Our results show that a life-long intake of aloe had superior anti-oxidative action against lipid peroxidation in vivo, as indicated by reduced levels of hepatic phosphatidylcholine hydroperoxide. Additional anti-oxidative action was evidenced by enhanced superoxide dismutase (SOD) and catalase activity in groups B and C. Furthermore, our study revealed that hepatic cholesterol significantly increased in the control group during aging in contrast to the aloe-supplemented groups, which showed approximately 30% lower cholesterol levels, thereby an effective hypocholesteremic efficacy. In this report, we suggest that life-long dietary aloe supplementation suppresses free radical-induced oxidative damage and age-related increases in hepatic cholesterol. PMID:14598919

  5. Efficacy of Vitamin C Supplements in Prevention of Cancer: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Lee, Bobae; Oh, Seung-Won

    2015-01-01

    Background Previous randomized controlled trials (RCTs) have reported inconsistent findings regarding the association between vitamin C supplementation and the risk of cancer. Methods We performed a meta-analysis of RCTs to investigate the efficacy of vitamin C supplements for prevention of cancer. We searched the PubMed, EMBASE, and Cochrane Library databases in November 2014 using common keywords related to vitamin C supplements and cancer. Results Among 785 articles, a total of seven trials were identified, which included 62,619 participants; 31,326 and 31,293 were randomized to vitamin C supplementation and control or placebo groups, respectively, which were included in the final analysis. A fixed-effects meta-analysis of all seven RCTs revealed no significant association between vitamin C supplementation and cancer (relative risk, 1.00; 95% confidence intervals, 0.95-1.05). Similarly, subgroup meta-analysis by dose of vitamin C administered singly or in combination with other supplements, follow-up period, methodological quality, cancer mortality, gender, smoking status, country, and type of cancer also showed no efficacy of vitamin C supplementation for cancer prevention. Conclusion This meta-analysis shows that there is no evidence to support the use of vitamin C supplements for prevention of cancer. PMID:26634093

  6. 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

  7. Efficacy of Vitamin and Antioxidant Supplements in Prevention of Esophageal Cancer: Meta-analysis of Randomized Controlled Trials

    PubMed Central

    Myung, Seung-Kwon; Yang, Hyo Jin

    2013-01-01

    Background: Observational epidemiological studies have shown that higher intakes of vitamins or antioxidants were inversely associated with the risk of esophageal cancer. However, randomized controlled trials (RCTs) have reported no preventive efficacy of vitamin or antioxidant supplements on esophageal cancer. This meta-analysis aimed to investigate the efficacy of vitamin and antioxidant supplements in the prevention of esophageal cancer as reported by RCTs. Methods: We searched PubMed, EMBASE, and the Cochrane Library in May 2013. Two authors independently reviewed and selected eligible articles based on predetermined selection criteria. Results: Of 171 articles searched from three databases and relevant bibliographies, 10 RCTs were included in the final analyses. In a fixed-effect meta-analysis of 10 trials, there was no efficacy of vitamin and antioxidant supplements in the prevention of esophageal cancer (relative risk [RR], 1.04; 95% confidence interval [CI], 0.86–1.25; I2=0.0%). Also, subgroup meta-analyses showed that vitamin and antioxidant supplements had no preventive efficacy on esophageal cancer both in the high risk (RR, 1.04; 95% CI, 0.85–1.28; n=4) and non-high risk (RR, 1.01; 95% CI, 0.65–1.56; n=6) groups for esophageal cancer. Further, subgroup meta-analyses revealed no preventive efficacy on esophageal cancer by type of methodological quality and type of vitamin and antioxidant supplements. Conclusions: Unlike observational epidemiological studies, this meta-analysis of RCTs suggests that there is no clinical evidence to support the efficacy of vitamin and antioxidant supplements in the prevention of esophageal cancer. PMID:25337539

  8. 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... nonattainment for the 1-hour ozone national ambient air quality standards (NAAQS) on November 6, 1991 (56 FR... (58 FR 50271). In this approval, was a 10-year air quality maintenance plan covering the years...

  9. Efficacy of Medications Approved for the Treatment of Alcohol Dependence and Alcohol Withdrawal Syndrome in Female Patients: A Descriptive Review.

    PubMed

    Agabio, Roberta; Pani, Pier Paolo; Preti, Antonio; Gessa, Gian Luigi; Franconi, Flavia

    2016-01-01

    The aim of this study was to evaluate whether the number of women recruited for studies to establish the efficacy of medications approved for treatment of alcohol dependence (AD) and of alcohol withdrawal syndrome (AWS) is sufficient to reveal possible gender differences in the response to these medications and in suggesting the use of different doses in female patients. Our results show that the rates of women recruited for studies evaluating the efficacy of disulfiram (1%), benzodiazepines (3%), and anticonvulsants (13%) were too low to establish possible gender differences. The rates of women recruited for studies evaluating the efficacy of acamprosate (22%), naltrexone (23%), and nalmefene (30%) were higher and allowed evaluation of data obtained for female patients. Women receive medications for treatment of AD and/or AWS for which efficacy has been demonstrated in studies in which men were more largely represented. PMID:26314552

  10. 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

  11. 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. PMID:25234322

  12. 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…

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... December 22, 2009.\\3\\ \\2\\ 17 CFR 202.190. See Release No. 33-8724 (July 18, 2006) [71 FR 41998 (July 24... Release No. 63526/December 10, 2010] Order Approving Public Company Accounting Oversight Board...-Oxley Act of 2002 \\1\\ (the ``Sarbanes-Oxley Act'') established the Public Company Accounting...

  15. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... solely affecting a natural product, a recombinant DNA-derived protein/polypeptide, or a complex or...) or references to previously approved documentation; (H) For a natural product, a recombinant DNA... this section; (B) Changes solely affecting a natural protein, a recombinant DNA-derived...

  16. 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. PMID:18537692

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

    PubMed Central

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

    2015-01-01

    Background 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. Methods 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. Results 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. Conclusions 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. PMID:26355679

  18. Cinryze as the first approved C1 inhibitor in the USA for the treatment of hereditary angioedema: approval, efficacy and safety.

    PubMed

    Lunn, Michael; Santos, Carah; Craig, Timothy

    2010-01-01

    Hereditary angioedema (HAE) is a clinical disorder characterized by a deficiency of C1 esterase inhibitor (C1-INH). HAE has traditionally been divided into two subtypes. Unique among the inherited deficiencies of the complement system, HAE Types I and II are inherited as an autosomal dominant disorder. The generation of an HAE attack is caused by the depletion and/or consumption of C1-inhibitor manifested as subcutaneous or submucosal edema of the upper airway, face, extremities, or gastrointestinal tract. Attacks can be severe and potentially life-threatening, particularly with laryngeal involvement. Despite the availability of C1-INH for the treatment of HAE since the 1980s in Europe and other countries, HAE treatment in the United States was limited to androgen therapy. The human plasma-derived C1 esterase inhibitor (Cinryze™), distributed by Lev Pharmaceuticals, was approved in October 2008 for the prevention of HAE attacks based on the results of a phase III clinical trial. This review aims to describe the history of C1-INH replacement in HAE as well as the pharmacology, efficacy and safety of C1-INH, concentrating on Cinryze as the first approved chronic replacement treatment for the prophylaxis of HAE attacks. PMID:22282695

  19. 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. PMID:24613855

  20. Review of the efficacy of green tea, isoflavones and aloe vera supplements based on randomised controlled trials.

    PubMed

    Williamson, Gary; Coppens, Patrick; Serra-Majem, Lluís; Dew, Tristan

    2011-12-01

    We assess the evidence for health benefits of three commonly consumed plant food supplements (PFS), green tea, isoflavone and aloe vera, based on published systematic reviews of randomised controlled trials (RCTs). Whilst the potential benefits of green tea have been reported in a wide range of health areas, it is only in the area of the metabolic syndrome that the number of RCTs is approaching sufficient to judge such efficacy. Isoflavone supplements are widely used, and RCTs indicate that they affect bone resorption at lower doses in postmenopausal women undergoing estrogen-related bone loss, but this is only translated to attenuation of bone loss at higher doses of isoflavones. A systematic review on RCTs concluded that the effects of isoflavones on hot flashes in postmenopausal women were highly variable and no conclusions could be drawn. Despite the popularity of aloe vera as a PFS, the evaluation of its efficacy as a coadjuvant therapy for certain metabolic or digestive pathologies remains scarce; it constitutes a typical example of a naturally occurring ingredient whose efficacy in topical applications presupposes its efficacy in systemic applications. Nevertheless, its possible toxic effects on oral consumption call for caution in its utility as a PFS. Since 2007, efficacy evaluation of PFS in Europe has been covered by European Union Nutrition and Health Claims legislation. The European Food Safety Authority has adopted an approach relying on RCTs, while medicinal effects are accepted based on traditional use. In general, there are insufficient RCTs for claims to be made, and conclusive results on PFS should be obtained in the future by conducting studies with more homogeneous populations, by using supplements with optimised and measured bioavailability, and by conducting larger RCTs. PMID:21927741

  1. 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

  2. Anti-fall Efficacy of Oral Supplemental Vitamin D and Active Vitamin D

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Results from fall prevention trials with supplemental vitamin D have been mixed and trials varied by dose, type of vitamin D (D3 = cholecalciferol or D2 = ergocalciferol), and quality of fall assessment. A possible differential benefit of supplemental versus alpha-hydroxylated vitamin D (active D) h...

  3. Efficacy of a crosslinked hyaluronic acid-based hydrogel as a tear film supplement: a masked controlled study.

    PubMed

    Williams, David L; Mann, Brenda K

    2014-01-01

    Keratoconjunctivitis sicca (KCS), or dry eye, is a significant medical problem in both humans and dogs. Treating KCS often requires the daily application of more than one type of eye drop in order to both stimulate tear prodcution and provide a tear supplement to increase hydration and lubrication. A previous study demonstrated the potential for a crosslinked hyaluronic acid-based hydrogel (xCMHA-S) to reduce the clinical signs associated with KCS in dogs while using a reduced dosing regimen of only twice-daily administration. The present study extended those results by comparing the use of the xCMHA-S to a standard HA-containing tear supplement in a masked, randomized clinical study in dogs with a clinical diagnosis of KCS. The xCMHA-S was found to significantly improve ocular surface health (conjunctival hyperaemia, ocular irritation, and ocular discharge) to a greater degree than the alternative tear supplement (P = 0.0003). Further, owners reported the xCMHA-S treatment as being more highly effective than the alternative tear supplement (P = 0.0024). These results further demonstrate the efficacy of the xCMHA-S in reducing the clinical signs associated with KCS, thereby improving patient health and owner happiness. PMID:24914681

  4. 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. PMID:26822872

  5. Prognostic Role of Vitamin D Status and Efficacy of Vitamin D Supplementation in Cancer Patients: A Systematic Review

    PubMed Central

    Buttigliero, Consuelo; Monagheddu, Chiara; Petroni, Paola; Saini, Andrea; Dogliotti, Luigi; Ciccone, Giovannino

    2011-01-01

    Background. Whether or not hypovitaminosis D can influence the prognosis of cancer patients and whether or not vitamin D (vitD) supplementation improves outcome remain controversial. Design. Studies evaluating the prognostic role of vitD and vitD receptor (VDR) in cancer patients and trials evaluating the efficacy of vitD administration on patient outcome were identified by a search of MEDLINE, EMBASE, ISI Web of Knowledge, and the Cochrane Library through June 2010. Results. Twenty-five studies were included. A negative prognostic role for low serum vitD level was observed in five cohort studies including patients with breast cancer (one study), colon cancer (two studies), prostate cancer (one study), and melanoma (one study), but not in two studies on non-small cell lung cancer and one study on breast cancer. Three of four studies showed that VDR+ tumors carry a better prognosis than VDR− tumors, whereas VDR polymorphisms were significantly associated with prognosis in five of 10 studies. A significant interaction between serum vitD level and VDR polymorphism was observed in one study. Three randomized trials involving advanced prostate cancer patients explored the prognostic role of vitD supplementation. A meta-analysis of these trials showed no effect on survival (pooled risk ratio, 1.07; 95% confidence interval, CI, 0.93–1.23), with strong heterogeneity among studies. Conclusion. Hypovitaminosis D seems to be associated with a worse prognosis in some cancers, but vitD supplementation failed to demonstrate a benefit in prostate cancer patients. The currently available evidence is insufficient to recommend vitD supplementation in cancer patients in clinical practice. PMID:21835895

  6. 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. PMID:26503419

  7. Dosing and efficacy of glutamine supplementation in human exercise and sport training.

    PubMed

    Gleeson, Michael

    2008-10-01

    Some athletes can have high intakes of l-glutamine because of their high energy and protein intakes and also because they consume protein supplements, protein hydrolysates, and free amino acids. Prolonged exercise and periods of heavy training are associated with a decrease in the plasma glutamine concentration and this has been suggested to be a potential cause of the exercise-induced immune impairment and increased susceptibility to infection in athletes. However, several recent glutamine feeding intervention studies indicate that although the plasma glutamine concentration can be kept constant during and after prolonged strenuous exercise, the glutamine supplementation does not prevent the postexercise changes in several aspects of immune function. Although glutamine is essential for lymphocyte proliferation, the plasma glutamine concentration does not fall sufficiently low after exercise to compromise the rate of proliferation. Acute intakes of glutamine of approximately 20-30 g seem to be without ill effect in healthy adult humans and no harm was reported in 1 study in which athletes consumed 28 g glutamine every day for 14 d. Doses of up to 0.65 g/kg body mass of glutamine (in solution or as a suspension) have been reported to be tolerated by patients and did not result in abnormal plasma ammonia levels. However, the suggested reasons for taking glutamine supplements (support for immune system, increased glycogen synthesis, anticatabolic effect) have received little support from well-controlled scientific studies in healthy, well-nourished humans. PMID:18806122

  8. 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…

  9. 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

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What requirements apply to a returned dietary... CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a...

  10. 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

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What requirements apply to a returned dietary... CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a...

  11. 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

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What requirements apply to a returned dietary... CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a...

  12. 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... CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a...

  13. 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

  14. 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…

  15. 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. PMID:25847603

  16. Efficacy of micronutrient supplementation on skin aging and seasonal variation: a randomized, placebo-controlled, double-blind study

    PubMed Central

    Fanian, Ferial; Mac-Mary, Sophie; Jeudy, Adeline; Lihoreau, Thomas; Messikh, Rafat; Ortonne, Jean-Paul; Sainthillier, Jean-Marie; Elkhyat, Ahmed; Guichard, Alexandre; Kenari, Kamran Hejazi; Humbert, Philippe

    2013-01-01

    Background Several studies have confirmed dramatic changes in skin surface parameters during the winter months. Although there are many studies supporting the positive effects of topical treatment, there are no published studies demonstrating the effects of oral supplementation in the prevention of negative skin changes during winter. The purpose of this study was to evaluate the efficacy of an oral micronutrient supplement in preventing the negative effects of winter weather on skin quality using noninvasive biometrologic instruments. Methods This study included 80 healthy female volunteers aged 35–55 years with phototype II–IV skin. Randomization was balanced. Two tablets of a micronutrient supplement (Perfectil® Platinum) or placebo were administered once daily for 4 months. The volunteers were examined at baseline, after 4 months, and 6 weeks after termination of treatment (month 5.5). The evaluation included skin microrelief by Visioscan® as the main outcome, and the secondary outcomes were results on standard macrophotography, skin tension by Reviscometer®, skin high-frequency ultrasound, and self-assessment. Results For all pseudoroughness and microrelief indicators, there was a significant increase from baseline to month 4 in the placebo group (P<0.05) but no change in the active group. Descriptive statistics for the mean minimum, mean maximum, and minimum to maximum ratio on the nonexposed study zone showed a significant and dramatic difference between baseline and month 4 and between baseline and month 5.5 (P<0.05) in the active group, indicating decreasing anisotropy of the skin. High-frequency ultrasound on the exposed study zone revealed that skin thickness was significantly decreased in the placebo group during winter but was stable in the treated group (P<0.01). The photography scaling and self-assessment questionnaire revealed no significant changes in either group. Conclusion These results indicate that the skin is prone to seasonal changes

  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. 30 CFR 550.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) Change the type of production or significantly increase the volume of production or storage capacity; (4) Increase the emissions of an air pollutant to an amount that exceeds the amount specified in your approved... EP, DPP, or DOCD? 550.283 Section 550.283 Mineral Resources BUREAU OF OCEAN ENERGY...

  19. 30 CFR 550.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) Change the type of production or significantly increase the volume of production or storage capacity; (4) Increase the emissions of an air pollutant to an amount that exceeds the amount specified in your approved... EP, DPP, or DOCD? 550.283 Section 550.283 Mineral Resources BUREAU OF OCEAN ENERGY...

  20. 30 CFR 550.283 - When must I revise or supplement the approved EP, DPP, or DOCD?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) Change the type of production or significantly increase the volume of production or storage capacity; (4) Increase the emissions of an air pollutant to an amount that exceeds the amount specified in your approved... EP, DPP, or DOCD? 550.283 Section 550.283 Mineral Resources BUREAU OF OCEAN ENERGY...

  1. 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. PMID:25310808

  2. 78 FR 21398 - Notice of Intent to Prepare a Supplemental Environmental Impact Statement for the Approval of a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-10

    ...This notice advises the public that the National Indian Gaming Commission (NIGC) as lead agency, in cooperation with the Jamul Indian Village (Tribe), intends to gather information necessary to prepare a supplemental environmental impact statement (SEIS) for the proposed Gaming Management Contract between the Tribe and San Diego Gaming Ventures, LLC (SDGV). The Gaming Management Contract, if......

  3. 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...

  4. 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. PMID:26983467

  5. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false PMA supplements. 814.39 Section 814.39 Food and... PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. (a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by...

  6. 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

  7. 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

  8. Patients' understanding of the regulation of dietary supplements.

    PubMed

    Ashar, Bimal H; Miller, Redonda G; Pichard, Carmen P; Levine, Rachel; Wright, Scott M

    2008-02-01

    The Dietary Supplement Health and Education Act (DSHEA) permits manufacturers to sell products without providing pre-market evidence of safety or efficacy. One fundamental reason for the passage of the DSHEA was to empower consumers to make their own choices, free from governmental restriction. Yet, little is known about the public's understanding of the supplement regulatory process. We undertook a study to assess patients' knowledge regarding governmental oversight of product marketing and advertising. A survey of 300 adult patients from the Baltimore Metropolitan area was administered after showing participants an advertisement for a dietary supplement. Patients were asked questions regarding their understanding of federal regulation of the advertised product. A total of 52% of respondents were unaware that the dietary supplement had not been approved by the government while 63% were unaware that the advertisement for that supplement had not been pre-approved. Factors associated with a lack of understanding of the product approval process included lower education level (OR 2.52; 95% CI 1.52-4.19) and non-Caucasian race (OR 1.99; 95% CI 1.17-3.36). Lower education level was also associated with confusion regarding the advertisement approval process (OR 2.60; 95% CI 1.48-4.57). Based on these results, patients seem unclear about the government's role in the regulation of dietary supplements. Educational efforts should be geared towards clarifying these issues. PMID:18080205

  9. 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

  10. Efficacy of folic acid supplementation on endothelial function and plasma homocysteine concentration in coronary artery disease: A meta-analysis of randomized controlled trials

    PubMed Central

    YI, XIN; ZHOU, YANLI; JIANG, DINGSHENG; LI, XIAOYAN; GUO, YI; JIANG, XUEJUN

    2014-01-01

    The aim of the present study was to conduct an updated meta-analysis of relevant randomized controlled trials (RCTs) in order to estimate the effect of folic acid supplementation on endothelial function and the concentration of plasma homocysteine in patients with coronary artery disease (CAD). An extensive search of PubMed was conducted to identify RCTs that compared folic acid with placebo therapy. The mean difference (MD) and 95% confidence interval (CI) were used as a measure of the correlation between folic acid supplementation and endothelial function/plasma homocysteine concentration. Of the 377 patients included in this analysis, 191 patients underwent folic acid supplementation and 186 individuals underwent placebo treatment. Compared with the use of a placebo, folic acid supplementation alone exhibited significant efficacy on increasing flow-mediated dilation (FMD; MD, 57.72 μm; 95% CI, 50.14–65.31; P<0.05) and lowering the concentration of plasma homocysteine (MD, −3.66 μmol/l; 95% CI, −5.44–−1.87; P<0.05; I2, 87%). There was no significant change in the response to end diastolic diameter, glyceryl-trinitrate diameter, heart rate, baseline and peak hyperemic flow and systolic and diastolic blood pressure between the folic acid and placebo groups (P>0.05). Therefore, the meta-analysis indicated that 5 mg folic acid daily supplementation for >4 weeks significantly improved FMD and lowered the concentration of plasma homocysteine in patients with CAD. However, more RCTs are required in order to confirm these observations. PMID:24940394

  11. Methotrexate catabolism to 7-hydroxy methotrexate in rheumatoid arthritis alters drug efficacy and retention and is reduced by folic acid supplements

    PubMed Central

    Baggott, Joseph E.; Morgan, Sarah L.

    2013-01-01

    Objective Urinary excretion of methotrexate (MTX) and its catabolite 7-hydroxy-MTX (7-OH-MTX) were measured in two 24-hour collections after MTX therapy in patients with rheumatoid arthritis. The effect of folic and folinic acid supplements on this catabolism was determined in patients and in vitro. The effect of this catabolism on MTX efficacy and in vivo retention was determined. Methods Urines were collected after 6 and 7 weeks of therapy. MTX and 7-OH-MTX concentrations were determined by a high performance liquid chromatography mass spectroscopy. Swelling (SW) and pain/tenderness (P/T) indices were measured before and at 6 and 7 weeks of therapy. Patients received either folic or folinic acid supplements (1mg/day) from week 6 to 7. Results Folic acid not folinic acid inhibited aldehyde oxidase (AO), the 7-OH-MTX producing enzyme. Excretion of 7-OH-MTX as % of dose or mg 7-OH-MTX / g creatinine was not normally distributed (n = 39). Patients with marked improvement in SW and P/T indices had lower mean 7-OH-MTX excretion (p <0.05). Folic acid supplementation lowered 7-OH-MTX excretion (p = 0.03). Relatively high 7-OH-MTX excretion was correlated (p<0.05) with relatively high MTX excretion and with relatively low in vivo MTX retention (n = 35). Conclusion Non-normal distribution of 7-OH-MTX excretion suggests at least two phenotypes for this catabolism. Lower 7-OH-MTX formation suggests folic acid inhibition of AO and a better clinical response. Higher 7-OH-MTX formation may interfere with MTX polyglutamylation and binding to enzymes and therefore increase MTX excretion, decrease in vivo MTX retention and efficacy. PMID:19644884

  12. 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

  13. Drugs, Herbs and Supplements: MedlinePlus

    MedlinePlus

    ... www.nlm.nih.gov/medlineplus/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 ...

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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...

  15. Supplementation of host response by targeting nitric oxide to the macrophage cytosol is efficacious in the hamster model of visceral leishmaniasis and adds to efficacy of amphotericin B.

    PubMed

    Pandya, Sanketkumar; Verma, Rahul Kumar; Khare, Prashant; Tiwari, Brajendra; Srinivasarao, Dadi A; Dube, Anuradha; Goyal, Neena; Misra, Amit

    2016-08-01

    We investigated efficacy of nitric oxide (NO) against Leishmania donovani. NO is a mediator of host response to infection, with direct parasiticidal activity in addition to its role in signalling to evoke innate macrophage responses. However, it is short-lived and volatile, and is therefore difficult to introduce into infected cells and maintain inracellular concentrations for meaningful periods of time. We incorporated diethylenetriamine NO adduct (DETA/NO), a prodrug, into poly(lactide-co-glycolide) particles of ∼200 nm, with or without amphotericin B (AMB). These particles sustained NO levels in mouse macrophage culture supernatants, generating an area under curve (AUC0.08-24h) of 591.2 ± 95.1 mM × h. Free DETA/NO resulted in NO peaking at 3 h and declining rapidly to yield an AUC of 462.5 ± 193.4. Particles containing AMB and DETA/NO were able to kill ∼98% of promastigotes and ∼76% of amastigotes in 12 h when tested in vitro. Promastigotes and amastigotes were killed less efficiently by particles containing a single drug- either DETA/NO (∼42%, 35%) or AMB (∼90%, 50%) alone, or by equivalent concentrations of drugs in solution. In a pre-clinical efficacy study of power >0.95 in the hamster model, DETA/NO particles were non-inferior to Fungizone® but not Ambisome®, resulting in significant (∼73%) reduction in spleen parasites in 7 days. Particles containing both DETA/NO and AMB were superior (∼93% reduction) to Ambisome®. We conclude that NO delivered to the cytosol of macrophages infected with Leishmania possesses intrinsic activity and adds significantly to the efficacy of AMB. PMID:27183429

  16. Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012).

    PubMed

    Bansal, Dipika; Bhagat, Anil; Schifano, Fabrizio; Gudala, Kapil

    2015-12-01

    The present study aimed at systematically reviewing the role and extent of patient-reported outcomes (PROs) usage within the package of scientific evidence considered for marketing authorization (MA). All regulatory information published by the European Medicines Agency (EMA) for products authorized between January 2008 and December 2012 and appearing in the European Public Assessment Report (EPAR) database was examined for efficacy endpoints. The endpoints here considered included: PROs, clinician reported outcomes (CROs), and laboratory reported outcomes (LROs). LROs were the most frequently reported endpoints. Out of the 180 products here selected, 99 (55%), 67 (37%), and 30 (17%), respectively, used LROs, CROs and PROs as primary endpoints (PEs). PROs as any endpoints were used in 82 (46%) products. Out of these, PROs were documented as PE in 30 (37%), with 27 (33%) products having used PROs both as primary and non-PEs. PRO usage was most frequently identified with nervous system and antineoplastic agents. During the study period, the use of all the three types of endpoints appeared to be static. Both the regulatory bodies and the industry should ensure complete and clear reporting of all endpoints used, including PROs, to improve transparency. PMID:26031612

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

    PubMed

    Mezzasalma, Valerio; Manfrini, Enrico; Ferri, Emanuele; Sandionigi, Anna; La Ferla, Barbara; Schiano, Irene; Michelotti, Angela; Nobile, Vincenzo; Labra, Massimo; Di Gennaro, Patrizia

    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

  18. 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

  19. Haptoglobin phenotype, preeclampsia risk and the efficacy of vitamin C and E supplementation to prevent preeclampsia in a racially diverse population.

    PubMed

    Weissgerber, Tracey L; Gandley, Robin E; McGee, Paula L; Spong, Catherine Y; Myatt, Leslie; Leveno, Kenneth J; Thorp, John M; Mercer, Brian M; Peaceman, Alan M; Ramin, Susan M; Carpenter, Marshall W; Samuels, Philip; Sciscione, Anthony; Harper, Margaret; Tolosa, Jorge E; Saade, George; Sorokin, Yoram

    2013-01-01

    Haptoglobin's (Hp) antioxidant and pro-angiogenic properties differ between the 1-1, 2-1, and 2-2 phenotypes. Hp phenotype affects cardiovascular disease risk and treatment response to antioxidant vitamins in some non-pregnant populations. We previously demonstrated that preeclampsia risk was doubled in white Hp 2-1 women, compared to Hp 1-1 women. Our objectives were to determine whether we could reproduce this finding in a larger cohort, and to determine whether Hp phenotype influences lack of efficacy of antioxidant vitamins in preventing preeclampsia and serious complications of pregnancy-associated hypertension (PAH). This is a secondary analysis of a randomized controlled trial in which 10,154 low-risk women received daily vitamin C and E, or placebo, from 9-16 weeks gestation until delivery. Hp phenotype was determined in the study prediction cohort (n = 2,393) and a case-control cohort (703 cases, 1,406 controls). The primary outcome was severe PAH, or mild or severe PAH with elevated liver enzymes, elevated serum creatinine, thrombocytopenia, eclampsia, fetal growth restriction, medically indicated preterm birth or perinatal death. Preeclampsia was a secondary outcome. Odds ratios were estimated by logistic regression. Sampling weights were used to reduce bias from an overrepresentation of women with preeclampsia or the primary outcome. There was no relationship between Hp phenotype and the primary outcome or preeclampsia in Hispanic, white/other or black women. Vitamin supplementation did not reduce the risk of the primary outcome or preeclampsia in women of any phenotype. Supplementation increased preeclampsia risk (odds ratio 3.30; 95% confidence interval 1.61-6.82, p<0.01) in Hispanic Hp 2-2 women. Hp phenotype does not influence preeclampsia risk, or identify a subset of women who may benefit from vitamin C and E supplementation to prevent preeclampsia. PMID:23573260

  20. 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

  1. Preliminary assessment of the efficacy of supplementing knee extension capability in a lower limb exoskeleton with FES.

    PubMed

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

    2012-01-01

    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

  2. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false PMA supplements. 814.39 Section 814.39 Food and... PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. Link to an amendment published at 75 FR 16351, Apr. 1, 2010. (a) After FDA's approval of a PMA, an...

  3. Comparative evaluation of efficacy and safety profile of rhubarb and α-keto analogs of essential amino acids supplementation in patients with diabetic nephropathy.

    PubMed

    Khan, Irfan Ahmad; Nasiruddin, Mohammad; Haque, Shahzad F; Khan, Rahat A

    2016-01-01

    To determine the efficacy and safety profile of rhubarb and α-keto analogs of essential amino acids supplementation in patients of diabetic nephropathy (DN), we studied 96 patients of DN attending a tertiary care center of the North India. The patients were randomly divided into three equal interventional groups. Group I (control) that received conservative management along with placebo, Group II (rhubarb) that received conservative management along with rhubarb capsule (350 mg, thrice daily), and Group III [keto amino acid (KAA)] that received conservative management along with α-keto analogs of essential amino acids (600 mg, thrice daily). The treatment was continued for 12 weeks. Clinical and biochemical parameters were assessed at 0, 4, 8, and 12 weeks of treatment. A progressive improvement in clinical features and biochemical parameters was seen in all three groups after 12 weeks of treatment. The KAA group showed more marked improvement in clinical features as well as biochemical parameters compared to the rhubarb group. There was a reduction in blood glucose, blood urea, serum creatinine, and 24 h total urine protein. There was an increase in hemoglobin, 24 h total urine volume, and glomerular filtration rate. There was no statistical difference between the rhubarb and KAA groups with respect to side effects (P > 0.05). Our study suggests that KAA is more effective than rhubarb as add-on therapy with conservative management in patients of DN. PMID:27424687

  4. Ingesting a preworkout supplement containing caffeine, creatine, β-alanine, amino acids, and B vitamins for 28 days is both safe and efficacious in recreationally active men.

    PubMed

    Kendall, Kristina L; Moon, Jordan R; Fairman, Ciaran M; Spradley, Brandon D; Tai, Chih-Yin; Falcone, Paul H; Carson, Laura R; Mosman, Matt M; Joy, Jordan M; Kim, Michael P; Serrano, Eric R; Esposito, Enrico N

    2014-05-01

    The purpose of this study was to determine the safety and efficacy of consuming a preworkout supplement (SUP) containing caffeine, creatine, β-alanine, amino acids, and B vitamins for 28 days. We hypothesized that little to no changes in kidney and liver clinical blood markers or resting heart rate and blood pressure (BP) would be observed. In addition, we hypothesized that body composition and performance would improve in recreationally active males after 28 days of supplementation. In a double-blind, placebo-controlled study, participants were randomly assigned to ingest one scoop of either the SUP or placebo every day for 28 days, either 20 minutes before exercise or ad libitum on nonexercise days. Resting heart rate and BP, body composition, and fasting blood samples were collected before and after supplementation. Aerobic capacity as well as muscular strength and endurance were also measured. Significant (P < .05) main effects for time were observed for resting heart rate (presupplementation, 67.59 ± 7.90 beats per minute; postsupplementation, 66.18 ± 7.63 beats per minute), systolic BP (presupplementation, 122.41 ± 11.25 mm Hg; postsupplementation, 118.35 ± 11.58 mm Hg), blood urea nitrogen (presupplementation, 13.12 ± 2.55 mg/dL; postsupplementation, 15.24 ± 4.47 mg/dL), aspartate aminotransferase (presupplementation, 34.29 ± 16.48 IU/L; postsupplementation, 24.76 ± 4.71 IU/L), and alanine aminotransferase (presupplementation, 32.76 ± 19.72 IU/L; postsupplementation, 24.88 ± 9.68 IU/L). Significant main effects for time were observed for body fat percentage (presupplementation, 15.55% ± 5.79%; postsupplementation, 14.21% ± 5.38%; P = .004) and fat-free mass (presupplementation, 70.80 ± 9.21 kg; postsupplementation, 71.98 ± 9.27 kg; P = .006). A significant decrease in maximal oxygen consumption (presupplementation, 47.28 ± 2.69 mL/kg per minute; postsupplementation, 45.60 ± 2.81 mL/kg per minute) and a significant increase in percentage of

  5. 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

  6. 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

  7. 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

    2016-01-01

    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

  8. Efficacy of mini VIDAS for the detection of Campylobacter spp. from retail broiler meat enriched in Bolton broth, with or without the supplementation of blood.

    PubMed

    Liu, Lin; Hussain, Syeda K; Miller, Robert S; Oyarzabal, Omar A

    2009-11-01

    The goals of this study were to evaluate the efficacy of the mini VIDAS automated immunoassay chemistry system to detect Campylobacter spp. from retail broiler meat enriched in Bolton broth supplemented with lysed blood (B+B) or without blood (B-B), and to detect positive samples at 24 versus 48 h after enrichment. Retail broiler meat was enriched and tested for Campylobacter spp. with the mini VIDAS and with an agar plate. Isolates were speciated with a multiplex PCR and typed with pulsed-field gel electrophoresis (PFGE) to evaluate relatedness of isolates collected from subsamples enriched in B+B or B-B. The number of Campylobacter-positive samples by mini VIDAS was similar (P > 0.05) to the results found with traditional plating media for naturally contaminated broiler meat, regardless of whether the comparison was made between B+B and B-B, or among different meat products (breast, tenders, and thighs). More positive samples were found at 48 h of enrichment than at 24 h of enrichment (P < 0.05). A Campylobacter jejuni:Campylobacter coli ratio of 4:1 was found in this study. Most of the isolates from both subsamples (B+B and B-B) were similar or identical by PFGE analysis, except for a few samples in which the PFGE profiles of the isolates from the subsamples were different. Mini VIDAS allowed for the detection of Campylobacter spp. within 48 h after enrichment. However, the sensitivity is similar to plate media, and retail broiler samples need to be enriched for 48 h to avoid false negatives. PMID:19903413

  9. Safety and efficacy of coenzyme Q10 supplementation in early chronic Peyronie's disease: a double-blind, placebo-controlled randomized study.

    PubMed

    Safarinejad, M R

    2010-01-01

    No oral medication has proved to be clearly beneficial for Peyronie's disease (PD). We investigated the safety and efficacy of coenzyme Q(10) (CoQ(10)) supplementation in patients with early chronic PD. We conducted a randomized clinical trial of 186 patients with chronic early PD. Patients were randomly assigned to either 300 mg CoQ(10) daily (n=93) or similar regimen of placebo (n=93) for 24 weeks. Erectile function (EF), pain during erection, plaque volume, penile curvature and treatment satisfaction using patient versions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire were assessed at baseline and every 4 weeks during study period. EF was assessed using International Index of Erectile Function (IIEF-5), and pain was evaluated with a visual analog scale (VAS, 0-10). All patients also responded to a Global Assessment Question, 'Has the treatment you have been taking during this study improved your erections?' After 24 weeks, mean IIEF-5 score, mean VAS score and mean EDITS score improved significantly in patients receiving CoQ(10) (all P<0.01). Mean plaque size and mean penile curvature degree were decreased in the CoQ(10) group, whereas a slight increase was noted in the placebo group (both P=0.001). Mean index of IIEF-5 in 24-week treatment period was 17.8 ± 2.7 in the CoQ(10) group and 8.8 ± 1.5 in the placebo group (P=0.001). Of the patients in CoQ(10) group, 11 (13.6%) had disease progression vs 46 (56.1%) in placebo group (P=0.01). In patients with early chronic PD, CoQ(10) therapy leads plaque size and penile curvature reduction and improves EF. PMID:20720560

  10. 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. PMID:27138439

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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...

  12. Dietary Supplements for Weight Loss

    MedlinePlus

    ... supplements, they won’t be listed on the product label and they could harm you. Weight-loss supplements can be sold without being tested or approved by the U.S. Food and Drug ... can recall that product. Visit this website to view the FDA’s public ...

  13. 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...

  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. 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

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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®...

  17. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Supplemental benefits. 422.102 Section 422.102... (CONTINUED) MEDICARE PROGRAM (CONTINUED) MEDICARE ADVANTAGE PROGRAM Benefits and Beneficiary Protections § 422.102 Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an...

  18. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 3 2011-10-01 2011-10-01 false Supplemental benefits. 422.102 Section 422.102... (CONTINUED) MEDICARE PROGRAM MEDICARE ADVANTAGE PROGRAM Benefits and Beneficiary Protections § 422.102 Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an MA organization...

  19. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Supplemental benefits. 422.102 Section 422.102... (CONTINUED) MEDICARE PROGRAM (CONTINUED) MEDICARE ADVANTAGE PROGRAM Benefits and Beneficiary Protections § 422.102 Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an...

  20. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Supplemental benefits. 422.102 Section 422.102... (CONTINUED) MEDICARE PROGRAM (CONTINUED) MEDICARE ADVANTAGE PROGRAM Benefits and Beneficiary Protections § 422.102 Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an...

  1. Brivaracetam: First Global Approval.

    PubMed

    Markham, Anthony

    2016-03-01

    Brivaracetam (Briviact(®)), a 4-n-propyl analogue of levetiracetam developed by UCB Pharma, has been approved in the EU as an adjunctive therapy for the treatment of partial-onset seizures. Brivaracetam binds to synaptic vesicle glycoprotein 2a (SV2A) in the brain with greater selectivity and 15- to 30-fold higher affinity than levetiracetam, as demonstrated in preclinical models, and has demonstrated efficacy in reducing the frequency of partial onset seizures in clinical trials. This article summarizes the milestones in the development of brivaracetam leading to this first approval for use as adjunctive therapy for uncontrolled partial-onset seizures in adults with epilepsy. PMID:26899665

  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. Efficacy of Multivitamin/mineral Supplementation to Reduce Chronic Disease Risk: A Critical Review of the Evidence from Observational Studies and Randomized Controlled Trials.

    PubMed

    Angelo, Giana; Drake, Victoria J; Frei, Balz

    2015-01-01

    We reviewed recent scientific evidence regarding the effects of multivitamin/mineral (MVM) supplements on risk of chronic diseases, including cancer, cardiovascular disease, and age-related eye diseases. Data from randomized controlled trials (RCTs) and observational, prospective cohort studies were examined. The majority of scientific studies investigating the use of MVM supplements in chronic disease risk reduction reported no significant effect. However, the largest and longest RCT of MVM supplements conducted to date, the Physicians' Health Study II (PHS II), found a modest and significant reduction in total and epithelial cancer incidence in male physicians, consistent with the Supplémentation en Vitamines et Minéraux Antioxydants (SU.VI.MAX) trial. In addition, PHS II found a modest and significant reduction in the incidence of nuclear cataract, in agreement with several other RCTs and observational, prospective cohort studies. The effects of MVM use on other subtypes of cataract and age-related macular degeneration remain unclear. Neither RCTs nor prospective cohort studies are without their limitations. The placebo-controlled trial design of RCTs may be inadequate for nutrient interventions, and residual confounding, measurement error, and the possibility of reverse causality are inherent to any observational study. National surveys show that micronutrient inadequacies are widespread in the US and that dietary supplements, of which MVMs are the most common type, help fulfill micronutrient requirements in adults and children. PMID:24941429

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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...

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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. 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…

  7. 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. PMID:27348226

  8. Antioxidative efficacy of parallel and combined supplementation with coenzyme Q10 and d-alpha-tocopherol in mildly hypercholesterolemic subjects: a randomized placebo-controlled clinical study.

    PubMed

    Kaikkonen, J; Nyyssönen, K; Tomasi, A; Iannone, A; Tuomainen, T P; Porkkala-Sarataho, E; Salonen, J T

    2000-09-01

    It has been claimed that coenzyme Q10 (Q10) would be an effective plasma antioxidant since it can regenerate plasma vitamin E. To test separate effects and interaction between Q10 and vitamin E in the change of plasma concentrations and in the antioxidative efficiency, we carried out a double-masked, double-blind clinical trial in 40 subjects with mild hypercholesterolemia undergoing statin treatment. Subjects were randomly allocated to parallel groups to receive either Q10 (200 mg daily), d-alpha-tocopherol (700 mg daily), both antioxidants or placebo for 3 months. In addition we investigated the pharmacokinetics of Q10 in a separate one-week substudy. In the group that received both antioxidants, the increase in plasma Q10 concentration was attenuated. Only vitamin E supplementation increased significantly the oxidation resistance of isolated LDL. Simultaneous Q10 supplementation did not increase this antioxidative effect of vitamin E. Q10 supplementation increased and vitamin E decreased significantly the proportion of ubiquinol of total Q10, an indication of plasma redox status in vivo. The supplementations used did not affect the redox status of plasma ascorbic acid. In conclusion, only vitamin E has antioxidative efficiency at high radical flux ex vivo. Attenuation of the proportion of plasma ubiquinol of total Q10 in the vitamin E group may represent in vivo evidence of the Q10-based regeneration of the tocopheryl radicals. In addition, Q10 might attenuate plasma lipid peroxidation in vivo, since there was an increased proportion of plasma ubiquinol of total Q10. PMID:10993487

  9. 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. PMID:19610435

  10. PA02.15. Validation of ayurvedic concept of anthropometry and clinical evaluation of efficacy of “Suktyadi Yog” as a calcium supplementation in children

    PubMed Central

    Kumar, S Vinod; Kumar, N Rakesh

    2013-01-01

    Purpose: The present study aims to validate the ayurvedic anthropometical parameter for assessment of proper growth & devlopment and also to identify any disease linkage. For proper bony growth adequate calcium supplement is necessary. Evaluation of role of an ayurvedic compound containing calcium preparation needed therefore included in the second phase of the study. In calcium deficiency Ayurvedic Managment “Suktyadi Yog” may be useful. It is a rich source of calcium and have deepaniya drugs. Deepaniya drugs is useful for absorption of calcium. Method: Validations of Ayurvedic Sharir pramana on the basis of modern concept (Parameters) in children and Peer review journals were searched to list content of “Suktyadi yog” with calcium supplementation activities, particularly acting in calcium deficient and healthy children. Result: Result of the study show Sharir praman of children found almost equal to as explained in ayurvedic texts. Out of all research Sukti bhasma, Godanti bhasma, yasad bhasma and Trikatu was found potent to reduce Calcium deficiency. It is very cost effective, easily available with highest calcium supplementation properties. Conclusion: Calcium deficiency is a major problem in children and “Suktyadi yog” is a best option to reduce it.

  11. 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. PMID:25982747

  12. 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

    2015-01-01

    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. PMID:25896576

  13. 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...

  14. 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. PMID:27117852

  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. PMID:26556207

  17. 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. PMID:26871553

  18. Evaluation of efficacy, safety and tolerability of high dose-intermittent calcitriol supplementation to advanced intrahepatic cholangiocarcinoma patients--a pilot study.

    PubMed

    Sookprasert, Aumkhae; Pugkhem, Ake; Khuntikeo, Narong; Chur-in, Siri; Chamadol, Nittaya; Prawan, Auemduan; Janeklang, Somkid; Vaeteewoottacharn, Kulthida; Kukongviriyapan, Veerapol; Pairojkul, Chawalit; Bhudhisawasdi, Vajarabhongsa; Wongkham, Sopit

    2012-01-01

    Antitumor activity (growth suppression) of vitamin D has been demonstrated using cholangiocarcinoma (CCA) cell lines, CCA cell-grafted animal models, and human CCA tissue cultures. The present study aimed to determine the toxicity and tolerability of intermittent-high dose calcitriol in advanced inoperable intrahepatic CCA patients and to evaluate the therapeutic efficacy of combinations of calcitriol and 5-fluorouracil-based chemotherapeutic drugs. The patients were divided into 3 groups: the first (n=2) received intermittent-high dose oral calcitriol 12 μg/day for 3 days, i.e. Monday-Wednesday, per week up to 3 months. The treatment did not cause any serious adverse events, except hypercalcemia grade I, once in 72 administrations. The second group (n=3) received chemotherapeutic drugs (5-fluorouracil, Mitomycin C and Leucovorin) for 3 cycles, one patient showing a partial response. The third group (n=4) received high dose calcitriol in combination with chemotherapeutic-drugs. All 4 patients encountered serious adverse events and two of them were withdrawn after the first drug cycle. This pilot study suggests that, although high dose-intermittent calcitriol appeared to be safe and tolerated well in advanced intrahepatic CCA patients, co-administration with 5-fluorouracil-based chemotherapeutic drugs caused unexpected potentiation of their toxicity. Adjustment of the doses of both drugs is required to avoid such toxicity and to optimize therapeutic efficacy of anticancer drugs when they were combined with high dose-intermittent calcitriol. PMID:23480759

  19. Dietary Supplements

    MedlinePlus

    Dietary supplements are vitamins, minerals, herbs, and many 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 ...

  20. Dietary Supplements

    MedlinePlus

    Dietary supplements are vitamins, minerals, herbs, and many other products. They can come as pills, capsules, powders, drinks, ... possible Tell your health care provider about any dietary supplements you use Do not take a bigger dose ...

  1. 7 CFR 1955.150 - State supplements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 14 2013-01-01 2013-01-01 false State supplements. 1955.150 Section 1955.150 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... CP must have prior approval of the National Office. Request for approval for those affecting MFH...

  2. 7 CFR 1955.150 - State supplements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 14 2014-01-01 2014-01-01 false State supplements. 1955.150 Section 1955.150 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... CP must have prior approval of the National Office. Request for approval for those affecting MFH...

  3. 7 CFR 1955.150 - State supplements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 14 2010-01-01 2009-01-01 true State supplements. 1955.150 Section 1955.150 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... CP must have prior approval of the National Office. Request for approval for those affecting MFH...

  4. 7 CFR 1955.150 - State supplements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 14 2011-01-01 2011-01-01 false State supplements. 1955.150 Section 1955.150 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... CP must have prior approval of the National Office. Request for approval for those affecting MFH...

  5. 7 CFR 1955.150 - State supplements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 14 2012-01-01 2012-01-01 false State supplements. 1955.150 Section 1955.150 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... CP must have prior approval of the National Office. Request for approval for those affecting MFH...

  6. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 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...

  7. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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...

  8. 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

  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. Chronic Supplementation of Curcumin Enhances the Efficacy of Antidepressants in Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.

    PubMed

    Yu, Jing-Jie; Pei, Liu-Bao; Zhang, Yong; Wen, Zi-Yu; Yang, Jian-Li

    2015-08-01

    Major depressive disorder is a devastating mental illness leading to a lifetime prevalence of higher than 16% on individuals. The treatment delay and inevitable adverse effects are major limitations of current depression interventions. Emerging evidence indicates that curcumin produced significant antidepressant properties in depression in both rodents and humans without adverse effects. Therefore, it is necessary to further clarify the antidepressant actions of curcumin and the underlying mechanism in depressed patients. A total of 108 male adults aged between 31 and 59 years were systematically recruited in Tianjin Anding Hospital. Subjects were administered the Chinese version of 17-item Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale that measures different scores of depressive symptoms. The subjects were asked to take 2 capsules containing either 1000 mg of curcumin or placebo soybean powder daily for 6 weeks on the basis of their current antidepressant medications. The plasma levels of interleukin 1β, tumor necrosis factor α, brain-derived neurotrophic factor, and salivary cortisol were measured by enzyme-linked immunosorbent assay before and after curcumin or placebo treatment during the 6-week procedure. Chronic supplementation with curcumin produced significant antidepressant behavioral response in depressed patients by reduction of 17-item Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale scores. Furthermore, curcumin decreases inflammatory cytokines interleukin 1β and tumor necrosis factor α level, increases plasma brain-derived neurotrophic factor levels, and decreases salivary cortisol concentrations compared with placebo group. These findings indicate the potential benefits of further implications of supplementary administration of curcumin to reverse the development of depression and enhance the outcome of antidepressants treatment in major depressive disorder. PMID:26066335

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

    PubMed

    Zhang, Chongyang; Yuan, Weigang; 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. 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

  13. 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. PMID:26679763

  14. Obiltoxaximab: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-05-01

    Obiltoxaximab (Anthim(®), ETI-204) is a monoclonal antibody that is being developed by Elusys Therapeutics and the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority for the prevention and treatment of inhalational anthrax due to Bacillus anthracis. Obiltoxaximab has been designed to neutralize the free protective antigen of B. anthracis, thereby inhibiting the lethal effects of anthrax toxins. In March 2016, intravenous obiltoxaximab was approved in the USA for the treatment (in combination with appropriate antibacterial drugs) and prophylaxis of inhalational anthrax. Obiltoxaximab is being developed under the US FDA Animal Rule, in which marketing approval is based on its efficacy in relevant animal models and safety in phase I studies in healthy human volunteers. An intramuscular formulation of obiltoxaximab has also been evaluated in animal studies and a phase I study in healthy human volunteers. This article summarizes the milestones in the development of obiltoxaximab leading to this first approval for the treatment and prevention of inhalation anthrax. PMID:27085536

  15. 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

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

    PubMed Central

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

    2016-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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. PROSPERO registration number CRD42016037104. PMID:27048637

  17. Dietary supplements.

    PubMed

    Maughan, Ron J; King, Doug S; Lea, Trevor

    2004-01-01

    For the athlete training hard, nutritional supplements are often seen as promoting adaptations to training, allowing more consistent and intensive training by promoting recovery between training sessions, reducing interruptions to training because of illness or injury, and enhancing competitive performance. Surveys show that the prevalence of supplement use is widespread among sportsmen and women, but the use of few of these products is supported by a sound research base and some may even be harmful to the athlete. Special sports foods, including energy bars and sports drinks, have a real role to play, and some protein supplements and meal replacements may also be useful in some circumstances. Where there is a demonstrated deficiency of an essential nutrient, an increased intake from food or from supplementation may help, but many athletes ignore the need for caution in supplement use and take supplements in doses that are not necessary or may even be harmful. Some supplements do offer the prospect of improved performance; these include creatine, caffeine, bicarbonate and, perhaps, a very few others. There is no evidence that prohormones such as androstenedione are effective in enhancing muscle mass or strength, and these prohormones may result in negative health consequences, as well as positive drug tests. Contamination of supplements that may cause an athlete to fail a doping test is widespread. PMID:14971436

  18. 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

  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...

  20. 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...

  1. 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...

  2. 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 trial123456

    PubMed Central

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

    2014-01-01

    Background: 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. Objective: The study sought to determine changes in total body reserves (TBRs) of vitamin A with consumption of biofortified maize. Design: A randomized, placebo-controlled biofortified maize efficacy trial was conducted in 140 rural Zambian children. The paired 13C-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+). Results: 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. Conclusions: 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

  3. Nutritional supplements for the treatment of ADHD.

    PubMed

    Bloch, Michael H; Mulqueen, Jilian

    2014-10-01

    Polyunsaturated fatty acid supplementation appears to have modest benefit for improving ADHD symptoms. Melatonin appears to be effective in treating chronic insomnia in children with ADHD but appears to have minimal effects in reducing core ADHD symptoms. Many other natural supplements are widely used in the United States despite minimal evidence of efficacy and possible side effects. This review synthesizes and evaluates the scientific evidence regarding the potential efficacy and side effects of natural supplements and herbal remedies for ADHD. We provide clinicians with recommendations regarding their potential use and role in overall ADHD treatment. PMID:25220092

  4. 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. ...

  5. 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)

  6. Dietary Supplements

    MedlinePlus

    ... take these supplements off the market. The Federal Trade Commission looks into reports of ads that might ... 504-5414 http://fnic.nal.usda.gov Federal Trade Commission 600 Pennsylvania Avenue, NW Washington, DC 20580 ...

  7. Dietary Supplements

    MedlinePlus

    ... are not intended to treat, diagnose, prevent, or cure diseases. Do not take supplements instead of your ... Partners Women's Health Topics Mammography Women and Diabetes HPV, HIV, Birth Control Heart Health for Women Pregnancy ...

  8. 5 CFR 7601.102 - Prior approval of outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... prohibited by statute or Federal regulation, including 5 CFR part 2635. (c) Scope of approval. Approval will.... 7601.102 Section 7601.102 Administrative Personnel NATIONAL ARCHIVES AND RECORDS ADMINISTRATION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL ARCHIVES AND RECORDS...

  9. 46 CFR 221.13 - General approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... consistent with the requirements of 46 CFR parts 252 and 294, this approval excludes and does not apply to... listed by the Department of Commerce in 15 CFR part 740, Supplement 1, Country Group E, unless such..., Charter, delivery, or any other manner of Transfer to a Noncitizen of an interest in or control of...

  10. 7 CFR 1717.901 - Early approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Early approval. 1717.901 Section 1717.901 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE POST-LOAN POLICIES AND PROCEDURES COMMON TO INSURED AND GUARANTEED ELECTRIC LOANS Lien Accommodations for Supplemental Financing Required...

  11. 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......

  12. 75 FR 16387 - Approval and Promulgation of Air Quality Implementation Plan: Kentucky; Approval Section 110(a)(1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ...EPA is announcing a limited 30-day reopening of the public comment period for the proposed rule entitled ``Approval and Promulgation of Air Quality Implementation Plan: Kentucky; Approval Section 110(a)(1) Maintenance Plan for the 1997 8-Hour Ozone Standard for the Owensboro Area,'' for the purpose of limited public review and comment on supplemental information that was provided by the......

  13. Dietary supplement drug therapies for depression.

    PubMed

    Howland, Robert H

    2012-06-01

    Many dietary supplements are readily accessible and commonly used for the treatment of depression. A dietary supplement is a product intended to supplement the diet but is not intended to treat, diagnose, prevent, or cure disease. The U.S. Food and Drug Administration can take action against dietary supplement manufacturers for products only after they are marketed, mainly if the product is found to be unsafe or if false or misleading claims are made about the product. Few dietary supplement products have been adequately studied for their safety and efficacy. Of the five products reviewed in this article (L-methylfolate, S-adenosyl-L-methionine [SAM-e], omega-3 fatty acids, L-tryptophan, and inositol), only omega-3 fatty acids and SAM-e have sufficient supporting evidence for their efficacy to warrant safe use. PMID:22589230

  14. 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.

  15. Drugs Approved for Leukemia

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Leukemia This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Acute Lymphoblastic Leukemia (ALL) Abitrexate (Methotrexate) Arranon (Nelarabine) Asparaginase Erwinia chrysanthemi ...

  16. Sports Supplements

    MedlinePlus

    ... specialist. The doc will be able to offer alternatives to supplements based on your body and sport. Reviewed by: Mary L. Gavin, MD Date reviewed: January 2015 previous 1 • 2 • 3 For Teens For Kids For Parents MORE ON THIS TOPIC Sports Center Energy Drinks and Food Bars: Power or Hype? A ...

  17. Glutamine supplementation.

    PubMed

    Wernerman, Jan

    2011-01-01

    Intravenous glutamine supplementation is standard care when parenteral nutrition is given for critical illness. There are data of a reduced mortality when glutamine supplementation is given. In addition, standard commercial products for parenteral nutrition do not contain any glutamine due to glutamine instability in aqueous solutions. For the majority of critical ill patients who are fed enterally, the available evidence is insufficient to recommend glutamine supplementation. Standard formulation of enteral nutrition contains some glutamine: 2-4 g/L. However, this dose is insufficient to normalize glutamine plasma concentration.Plasma concentration of glutamine is low in many patients with critical illness and a low level is an independent risk factor for mortality. A low plasma glutamine concentration is the best indicator of glutamine depletion. Data are emerging about how the endogenous production of glutamine is regulated. We know that skeletal muscle is the major producer of glutamine and that a part of the profound depletion of skeletal muscle seen in critical illness is a reflection of the need to produce glutamine.Glutamine is utilized in rapidly dividing cells in the splanchnic area. Quantitatively most glutamine is oxidized, but the availability of glutamine in surplus is important for the de novo synthesis of nucleotides and necessary for cell division and protein synthesis. More knowledge about the regulation of the endogenous production of glutamine is needed to outline better guidelines for glutamine supplementation in the future. PMID:21906372

  18. Calcium supplements

    MedlinePlus

    ... SHOULD TAKE CALCIUM SUPPLEMENTS? Calcium is an important mineral for the human body. It helps build and protect your teeth ... absorb calcium. You can get vitamin D from sunlight exposure to your skin and from your diet. Ask your provider whether ...

  19. 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…

  20. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... environmental review or for which an environmental assessment or EIS has not been approved by the Fund. The... 12 Banks and Banking 9 2012-01-01 2012-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated...

  1. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... environmental review or for which an environmental assessment or EIS has not been approved by the Fund. The... 12 Banks and Banking 7 2011-01-01 2011-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated...

  2. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... environmental review or for which an environmental assessment or EIS has not been approved by the Fund. The... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated...

  3. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... environmental review or for which an environmental assessment or EIS has not been approved by the Fund. The... 12 Banks and Banking 9 2013-01-01 2013-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated...

  4. 12 CFR 1815.106 - Supplemental environmental review.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... environmental review or for which an environmental assessment or EIS has not been approved by the Fund. The... 12 Banks and Banking 10 2014-01-01 2014-01-01 false Supplemental environmental review. 1815.106... TREASURY ENVIRONMENTAL QUALITY § 1815.106 Supplemental environmental review. (a) The designated...

  5. Supplemental Training and Employment Programs (STEP) Handbook.

    ERIC Educational Resources Information Center

    Manpower Administration (DOL), Washington, DC.

    The handbook provides a thorough description of the philosophy and operating instructions of the Supplemental Training and Employment Program (STEP). It includes the background; purpose and description; sponsorship; project development, review, approval and funding; project duration; eligibility requirements; length of enrollment; participant…

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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...

  11. 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. PMID:25007363

  12. 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. PMID:19925842

  13. Do dietary supplements help promote weight loss?

    PubMed

    Bell, Stacey J; Van Ausdal, Wendy; Grochoski, Greg

    2009-01-01

    As two-thirds of the US population is overweight or obese, new strategies are needed to help individuals safely and effectively lose weight. One option is to use dietary supplements, but not all supplements that are touted for weight loss have published clinical support for efficacy. The purpose of this article was to identify all published articles on dietary supplements for weight loss. Effectiveness of these supplements was defined as promoting 1-2 lb of weight loss each week. Although several dozen different dietary supplements are sold, only 14 published studies were identified. Four individual ingredients and three blends of ingredients were considered to be effective. Additionally, we compared weight loss from these dietary supplements to over-the-counter (OTC) orlistat (alli™, GlaxoSmithKline, Brentford, UK). Five single ingredients and three blends of ingredients produced more weight loss than OTC orlistat. Persons who use dietary supplements for weight management, counsel patients on how to lose weight, and retailers who sell dietary supplements, should become familiar with those supplements only that are effective at producing weight loss to assure the best results. PMID:22435353

  14. Diabetes and Dietary Supplements

    MedlinePlus

    ... R S T U V W X Y Z Diabetes and Dietary Supplements: In Depth Share: On This ... health product or practice. Are dietary supplements for diabetes safe? Some dietary supplements may have side effects, ...

  15. 77 FR 50702 - Ranbaxy Laboratories Limited; Withdrawal of Approval of 27 Abbreviated New Drug Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... supplements thereto, is hereby withdrawn, effective September 21, 2012. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section...

  16. Medication Treatment Efficacy and Chronic Orofacial Pain.

    PubMed

    Clark, Glenn T; Padilla, Mariela; Dionne, Raymond

    2016-08-01

    Chronic pain in the orofacial region has always been a vexing problem for dentists to diagnose and treat effectively. For trigeminal neuropathic pain, there are 3 medications (gabapentinoids, tricyclic antidepressants, and serotonin-norepinephrine reuptake inhibitors) to use plus topical anesthetics that have therapeutic efficacy. For chronic daily headaches (often migraine in origin), 3 prophylactic medications have reasonable therapeutic efficacy (β-blockers, tricyclic antidepressants, and antiepileptic drugs). The 3 Food and Drug Administration-approved drugs for fibromyalgia (pregabalin, duloxetine, and milnacipran) are not robust, with poor efficacy. For osteroarthritis, nonsteroidal anti-inflammatory drugs have therapeutic efficacy and when gastritis contraindicates them, corticosteriod injections are helpful. PMID:27475515

  17. Reading Intervention in Middle and High Schools: Implementation Fidelity, Teacher Efficacy, and Student Achievement

    ERIC Educational Resources Information Center

    Cantrell, Susan Chambers; Almasi, Janice F.; Carter, Janis C.; Rintamaa, Margaret

    2013-01-01

    This study investigated teachers' efficacy and implementation in the context of a supplemental intervention for struggling adolescent readers. It examined teachers' efficacy at the start of their intervention training and investigated relationships among teachers' efficacy, implementation, and students' reading progress. The efficacy and…

  18. 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. PMID:27441881

  19. 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. PMID:23668655

  20. Dietary nitrate supplementation and exercise performance.

    PubMed

    Jones, Andrew M

    2014-05-01

    Dietary nitrate is growing in popularity as a sports nutrition supplement. This article reviews the evidence base for the potential of inorganic nitrate to enhance sports and exercise performance. Inorganic nitrate is present in numerous foodstuffs and is abundant in green leafy vegetables and beetroot. Following ingestion, nitrate is converted in the body to nitrite and stored and circulated in the blood. In conditions of low oxygen availability, nitrite can be converted into nitric oxide, which is known to play a number of important roles in vascular and metabolic control. Dietary nitrate supplementation increases plasma nitrite concentration and reduces resting blood pressure. Intriguingly, nitrate supplementation also reduces the oxygen cost of submaximal exercise and can, in some circumstances, enhance exercise tolerance and performance. The mechanisms that may be responsible for these effects are reviewed and practical guidelines for safe and efficacious dietary nitrate supplementation are provided. PMID:24791915

  1. 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

  2. Efficacy and Safety of Oral Lactoferrin Supplementation in Combination with rHuEPO-β for the Treatment of Anemia in Advanced Cancer Patients Undergoing Chemotherapy: Open-Label, Randomized Controlled Study

    PubMed Central

    Madeddu, Clelia; Gramignano, Giulia; Mulas, Carlo; Sanna, Eleonora; Mantovani, Giovanni

    2010-01-01

    Advanced-stage cancer patients often suffer from anemia that closely resembles the anemia of chronic inflammatory diseases characterized by specific changes in iron homeostasis and absorption. i.v. iron improves the efficacy of recombinant human erythropoietin (rHuEPO) in anemic cancer patients undergoing chemotherapy. We report the results of an open-label, randomized, prospective trial aimed at testing the efficacy and safety of treatment with oral lactoferrin versus i.v. iron, both combined with rHuEPO, for the treatment of anemia in a population of 148 advanced cancer patients undergoing chemotherapy. All patients received s.c. rHuEPO-β, 30,000 UI once weekly for 12 weeks, and were randomly assigned to ferric gluconate (125 mg i.v. weekly) or lactoferrin (200 mg/day). Both arms showed a significant hemoglobin increase. No difference in the mean hemoglobin increase or the hematopoietic response, time to hematopoietic response, or mean change in serum iron, C-reactive protein, or erythrocyte sedimentation rate were observed between arms. In contrast, ferritin decreased in the lactoferrin arm whereas it increased in the i.v. iron arm. In conclusion, these results show similar efficacy for oral lactoferrin and for i.v. iron, combined with rHuEPO, for the treatment of anemia in advanced cancer patients undergoing chemotherapy. PMID:20647390

  3. 5 CFR 3601.107 - Prior approval for outside employment and business activities.

    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 and 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...

  4. 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. 3 (Stationary Source Permitting and Air Pollutant Emission Notice Requirements) that incorporate EPA's December 31, 2002 NSR Reforms. Colorado submitted the request for approval of these rule revisions into the State Implementation Plan (SIP) on July 11, 2005 and supplemented its request on......

  5. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Virginia plan... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to...

  6. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Virginia plan... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to...

  7. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Virginia plan... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to...

  8. 29 CFR 1952.374 - Final approval determination.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Virginia plan... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... under the Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to...

  9. 29 CFR 1952.354 - Final approval determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... Act and implementing regulations at 29 CFR part 1902. Accordingly, the Arizona plan was granted final... effective as operations under the Federal program; to submit plan supplements in accordance with 29 CFR...

  10. 29 CFR 1952.354 - Final approval determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... Act and implementing regulations at 29 CFR part 1902. Accordingly, the Arizona plan was granted final... effective as operations under the Federal program; to submit plan supplements in accordance with 29 CFR...

  11. 29 CFR 1952.354 - Final approval determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... Act and implementing regulations at 29 CFR part 1902. Accordingly, the Arizona plan was granted final... effective as operations under the Federal program; to submit plan supplements in accordance with 29 CFR...

  12. 5 CFR 3301.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... statute or Federal regulation, including 5 CFR part 2635. (c) Definition of employment. For purposes of.... 3301.103 Section 3301.103 Administrative Personnel DEPARTMENT OF ENERGY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF ENERGY § 3301.103 Prior approval for outside...

  13. 5 CFR 3301.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... statute or Federal regulation, including 5 CFR part 2635. (c) Definition of employment. For purposes of.... 3301.103 Section 3301.103 Administrative Personnel DEPARTMENT OF ENERGY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF ENERGY § 3301.103 Prior approval for outside...

  14. 5 CFR 3301.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... statute or Federal regulation, including 5 CFR part 2635. (c) Definition of employment. For purposes of.... 3301.103 Section 3301.103 Administrative Personnel DEPARTMENT OF ENERGY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF ENERGY § 3301.103 Prior approval for outside...

  15. 5 CFR 3301.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... statute or Federal regulation, including 5 CFR part 2635. (c) Definition of employment. For purposes of.... 3301.103 Section 3301.103 Administrative Personnel DEPARTMENT OF ENERGY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF ENERGY § 3301.103 Prior approval for outside...

  16. 5 CFR 3301.103 - Prior approval for outside employment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... statute or Federal regulation, including 5 CFR part 2635. (c) Definition of employment. For purposes of.... 3301.103 Section 3301.103 Administrative Personnel DEPARTMENT OF ENERGY SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF ENERGY § 3301.103 Prior approval for outside...

  17. 5 CFR 4301.101 - 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. 4301.101 Section 4301.101 Administrative Personnel OVERSEAS PRIVATE INVESTMENT CORPORATION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE OVERSEAS PRIVATE INVESTMENT CORPORATION § 4301.101...

  18. 14 CFR 121.162 - ETOPS Type Design Approval Basis.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false ETOPS Type Design Approval Basis. 121.162... REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Aircraft Requirements § 121.162 ETOPS Type Design... February 17, 2015 and except for a two-engine airplane that, when used in ETOPS, is only used for ETOPS...

  19. 29 CFR 1952.224 - Final approval determination.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... section 18(e) of the Act and implementing regulations at 29 CFR part 1902. Accordingly, the Tennessee plan... Final approval determination. (a) In accordance with section 18(e) of the Act and procedures in 29 CFR... Federal program; to submit plan supplements in accordance with 29 CFR part 1953; to allocate...

  20. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order... continued distribution of the device would cause serious, adverse health consequences or death....

  1. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order... continued distribution of the device would cause serious, adverse health consequences or death....

  2. 21 CFR 814.47 - Temporary suspension of approval of a PMA.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order... continued distribution of the device would cause serious, adverse health consequences or death....

  3. 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,......

  4. 75 FR 6186 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 205...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-08

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 205, Publicizing Contract Actions AGENCY: Defense Acquisition Regulations System... approved information collection requirement. SUMMARY: In compliance with Section 3506(c)(2)(A) of...

  5. 75 FR 12518 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 237...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-16

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 237, Service Contracting AGENCY: Defense Acquisition Regulations System... approved information collection requirement. SUMMARY: In compliance with Section 3506(c)(2)(A) of...

  6. 78 FR 15935 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS); Bonds and Insurance AGENCY: Defense Acquisition Regulations System, Department... approved information collection requirement. SUMMARY: In compliance with Section 3506(c)(2)(A) of...

  7. 75 FR 20825 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; DoD Pilot...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; DoD Pilot Mentor-Protege Program AGENCY: Defense Acquisition Regulations System... approved information collection requirement. ] SUMMARY: In compliance with section 3506(c)(2)(A) of...

  8. 75 FR 20825 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 211...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 211, Describing Agency Needs AGENCY: Defense Acquisition Regulations System... approved information collection requirement. SUMMARY: In compliance with Section 3506(c)(2)(A) of...

  9. 78 FR 70025 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... Defense Acquisition Regulations System Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Subcontracting Policies and Procedures AGENCY: Defense Acquisition Regulations System... approved information collection requirement. SUMMARY: In compliance with section 3506(c)(2)(A) of...

  10. The Seal of Approval.

    ERIC Educational Resources Information Center

    Ziv, Micaela

    1997-01-01

    Israel's Software Evaluation Project sets national standards for hardware and software that is used in schools. All courseware must be approved for technical requirements and pedagogical content. After approval, the courseware is certified for use within Israel's school system for 2 years. Three times each year, schools, inspectorates, and…

  11. 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. PMID:27296599

  12. 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

  13. Drugs Approved for Thyroid Cancer

    MedlinePlus

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

  14. 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 ...

  15. 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) ...

  16. Drugs Approved for Breast Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Breast Cancer This page lists cancer drugs approved by the ... are not listed here. Drugs Approved to Prevent Breast Cancer Evista (Raloxifene Hydrochloride) Keoxifene (Raloxifene Hydrochloride) Nolvadex (Tamoxifen ...

  17. Drugs Approved for Bone Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Bone Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Bone Cancer Abitrexate (Methotrexate) Cosmegen (Dactinomycin) Dactinomycin Denosumab Doxorubicin Hydrochloride ...

  18. Drugs Approved for Myeloproliferative Disorders

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Myeloproliferative Neoplasms This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Myeloproliferative Neoplasms Adriamycin PFS (Doxorubicin Hydrochloride) Adriamycin RDF (Doxorubicin Hydrochloride) ...

  19. Sofosbuvir: first global approval.

    PubMed

    Keating, Gillian M; Vaidya, Asha

    2014-02-01

    Sofosbuvir (Solvadi™), a nucleotide analogue hepatitis C virus NS5B polymerase inhibitor, is under development with Gilead Sciences for the once-daily, oral treatment of chronic hepatitis C. Oral sofosbuvir has been approved in the US for the treatment of chronic hepatitis C as a component of a combination antiviral regimen. In addition, the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of sofosbuvir for the treatment of chronic hepatitis C. This article summarizes the milestones in the development of sofosbuvir leading to this first approval for chronic hepatitis C. PMID:24442794

  20. Multivitamin/Mineral Supplements

    MedlinePlus

    ... Nutrient recommendations: Dietary Reference Intakes (DRI) Online DRI tool Daily Value (DV) tables For more advice on buying dietary supplements: Office of Dietary Supplements Frequently Asked Questions: Which brand(s) ...

  1. Children and Dietary Supplements

    MedlinePlus

    ... NCCIH Clinical Digest for health professionals Children and Dietary Supplements Share: September 2012 © Matthew Lester Research has shown that many children use herbs and other dietary supplements. However, there are little data available on their ...

  2. Drugs Approved for Melanoma

    MedlinePlus

    ... are not listed here. Drugs Approved for Melanoma Aldesleukin Cobimetinib Cotellic (Cobimetinib) Dabrafenib Dacarbazine DTIC-Dome (Dacarbazine) IL-2 (Aldesleukin) Imlygic (Talimogene Laherparepvec) Interleukin-2 (Aldesleukin) Intron A ( ...

  3. 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.

  4. 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.

  5. 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.

  6. 5 CFR 5502.103 - Content of annual supplemental reports.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... part 5501 of this chapter that were approved pursuant to 5 CFR 5501.106(d) or undertaken within the.... 5502.103 Section 5502.103 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES §...

  7. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... sufficiency of animal data, the agency may take into account other data, including human data, available to... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610...

  8. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... sufficiency of animal data, the agency may take into account other data, including human data, available to... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610...

  9. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... sufficiency of animal data, the agency may take into account other data, including human data, available to... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610...

  10. 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

  11. 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…

  12. 34 CFR 200.88 - Exclusion of supplemental State and local funds from supplement, not supplant and comparability...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... under part C of Title I may exclude supplemental State and local funds expended in any school attendance area or school for carrying out special programs that meet the intent and purposes of part C of Title I... met. (Approved by the Office of Management and Budget under control number 1810-0662) (Authority 20...

  13. Target selection for FDA-approved medicines.

    PubMed

    Kinch, Michael S; Hoyer, Denton; Patridge, Eric; Plummer, Mark

    2015-07-01

    The biopharmaceutical industry translates fundamental understanding of disease into new medicines. As part of a comprehensive analysis of FDA-approved new molecular entities (NMEs), we assessed the mechanistic basis of drug efficacy, with emphasis on target selection. Three target families capture almost half of all NMEs and the leading ten families capture more than three-quarters of NME approvals. Target families were related to their clinical application and identify dynamic trends in targeting over time. These data suggest increasing attention toward novel target families, which presumably reflects increased understanding of disease etiology. We also suggest the need to balance the ongoing emphasis on target-based drug discovery with phenotypic approaches to drug discovery. PMID:25462532

  14. OLDER ADULTS WHO USE VITAMIN/MINERAL SUPPLEMENTS DIFFER FROM NONUSERS IN NUTRIENT INTAKE ADEQUACY AND DIETARY ATTITUDES

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The purpose of this study was to measure nutrient intake adequacy of vitamin/mineral supplement users and nonusers 51 years and older, determine the efficacy of current supplement practices, and identify predictors of supplement use. Two 24-hour recalls, and demographic and attitude information fro...

  15. Fall prevention with supplemental and alpha-hydroxylated vitamin D: a meta-analysis of randomized controlled trials

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Results from fall prevention trials with supplemental vitamin D have been mixed and a possible differential benefit of supplemental versus alpha-hydroxylated vitamin D (activeD) has not been established. We performed a meta-analysis on the efficacy of supplemental vitamin D and activeD with or witho...

  16. 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. PMID:24464309

  17. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., 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 or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  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

    ..., 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 or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., 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 or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  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

    ..., 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 or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  1. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., 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 or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  2. MSHA approval process

    SciTech Connect

    Chirdon, D.C.

    1999-07-01

    The hazardous nature of the underground mining environment necessitates the use of equipment and mining products designed to ensure safe usage in this hostile environment. Title 30, code of federal regulations (30 CFR) includes requirements that all equipment and products intended for use in potentially gassy areas of underground mines be approved by the mine safety and health administration (MSHA). Design and performance requirements for many of the products intended for use in the underground environment are also part of 30 CFR. This paper describes the processes available to potential applicants for obtaining MSHA approval. Emphasis is placed on ventilation-related products. A program available to operators for modifying approved equipment is described. A proposed regulation that would broaden the scope of design standards accepted by MSHA is discussed.

  3. Ramucirumab: first global approval.

    PubMed

    Poole, Raewyn M; Vaidya, Asha

    2014-06-01

    Ramucirumab (Cyramza™ [US]), a fully human immunoglobulin G1 (IgG1) monoclonal antibody that inhibits vascular endothelial growth factor receptor-2 (VEGFR-2), has been developed by Eli Lilly (formerly ImClone Systems) for the treatment of cancer. Ramucirumab has received its first global approval in the US for use as monotherapy in the treatment of advanced or metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in patients who experience disease progression on or after fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is the first treatment to be approved by the US FDA for this setting. This article summarizes the milestones in the development of ramucirumab leading to this first approval for the treatment of gastric cancer and gastro-oesophageal junction adenocarcinoma. PMID:24916147

  4. Marketing approval of mogamulizumab

    PubMed Central

    Beck, Alain; Reichert, Janice M.

    2012-01-01

    Therapeutic properties of antibodies strongly depend on the composition of their glycans. Most of the currently approved antibodies are produced in mammalian cell lines, which yield mixtures of different glycoforms that are close to those of humans, but not fully identical. Glyco-engineering is being developed as a method to control the composition of carbohydrates and to enhance the pharmacological properties of mAbs. The recent approval in Japan of mogamulizumab (POTELIGEO®), the first glyco-engineered antibody to reach the market, is a landmark in the field of therapeutic antibodies. Mogamulizumab is a humanized mAb derived from Kyowa Hakko Kirin’s POTELLIGENT® technology, which produces antibodies with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity. The approval was granted April 30, 2012 by the Japanese Ministry of Health, Labour and Welfare for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma. PMID:22699226

  5. [Efficacy studies].

    PubMed

    Pedro-Botet, Juan; Flores-Le Roux, Juana A

    2014-07-01

    Pravafenix(®) is a fixed-dose combination of 40mg of pravastatin and 160 mg of fenofibrate. The rationale behind the use of Pravafenix(®) is based on the increased residual cardiovascular risk observed in high risk patients with hypertriglyceridemia and/or low HDL cholesterol levels despite treatment with statins in monotherapy. In this article, we review the available evidence on the clinical efficacy of Pravafenix(®), which shows complementary benefits in the overall lipid profile of high risk patients with mixed dyslipidemia not controlled with 40-mg pravastatin or 20-mg simvastatin. PMID:25043542

  6. Pimavanserin: First Global Approval.

    PubMed

    Markham, Anthony

    2016-07-01

    Pimavanserin (Nuplazid™) is a selective and potent serotonin 2A (5-HT2A) receptor inverse agonist and antagonist developed by ACADIA Pharmaceuticals that has been approved in the US as a treatment for patients with hallucinations and delusions associated with Parkinson's disease psychosis. Up to 60 % of patients with Parkinson's disease may develop Parkinson's disease psychosis, which is associated with increased morbidity and mortality and has few treatment options. This article summarizes the milestones in the development of pimavanserin leading to this first approval for the treatment of hallucinations and delusions in patients with Parkinson's disease psychosis. PMID:27262680

  7. Migalastat: First Global Approval.

    PubMed

    Markham, Anthony

    2016-07-01

    Migalastat (Galafold™)-a small molecule drug developed by Amicus Therapeutics that restores the activity of specific mutant forms of α-galactosidase-has been approved for the treatment of Fabry disease in the EU in patients with amenable mutations. Fabry disease is a rare disorder that results in a deficiency or absence of α-galactosidase, leading to accumulation of globotriaosylceramide in the lysosomes of various cells. This article summarizes the milestones in the development of migalastat leading to this first approval in the EU for the long-term treatment of adults and adolescents aged ≥16 years with a confirmed diagnosis of Fabry disease. PMID:27351440

  8. Brodalumab: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-09-01

    Brodalumab (Lumicef(®)) is a human monoclonal immunoglobulin G antibody that is being developed by Kyowa Hakko Kirin in Japan, where it has been approved for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. Brodalumab binds with high affinity to interleukin (IL)-17 receptor A, thereby inhibiting several pro-inflammatory cytokines from the IL-17 family. Regulatory applications for brodalumab in plaque psoriasis are also under review in the USA, EU and Canada. This article summarizes the milestones in the development of brodalumab leading to this first approval for the treatment of psoriasis. PMID:27577550

  9. 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

  10. 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