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Vitamin D Supplementation for Prevention of Mortality in Adults (Review)

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Vitamin D Supplementation for Prevention of Mortality in Adults (Review) Cochrane Database of Systematic Reviews Vitamin D supplementation for prevention of mortality in adults (Review) Bjelakovic G, Gluud LL, Nikolova D, Whitfield K, Wetterslev J, Simonetti RG, Bjelakovic M, Gluud C Bjelakovic G, Gluud LL, Nikolova D, Whitfield K, Wetterslev J, Simonetti RG, Bjelakovic M, Gluud C. Vitamin D supplementation for prevention of mortality in adults. Cochrane Database of Systematic Reviews 2014, Issue 1. Art. No.: CD007470. DOI: 10.1002/14651858.CD007470.pub3. www.cochranelibrary.com Vitamin D supplementation for prevention of mortality in adults (Review) Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . ..... 4 BACKGROUND .................................... 8 OBJECTIVES ..................................... 9 METHODS ...................................... 9 RESULTS....................................... 13 Figure1. ..................................... 14 Figure2. ..................................... 17 Figure3. ..................................... 18 Figure4. ..................................... 21 Figure5. ..................................... 22 Figure6. ..................................... 24 DISCUSSION ..................................... 26 AUTHORS’CONCLUSIONS . 31 ACKNOWLEDGEMENTS . 31 REFERENCES ..................................... 31 CHARACTERISTICSOFSTUDIES . 56 DATAANDANALYSES. 153 ADDITIONALTABLES. 156 WHAT’SNEW..................................... 175 CONTRIBUTIONSOFAUTHORS . 176 DECLARATIONSOFINTEREST . 176 SOURCESOFSUPPORT . 176 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . .... 177 INDEXTERMS .................................... 177 Vitamin D supplementation for prevention of mortality in adults (Review) i Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Vitamin D supplementation for prevention of mortality in adults Goran Bjelakovic1,2, Lise Lotte Gluud3, Dimitrinka Nikolova2, Kate Whitfield4, Jørn Wetterslev4, Rosa G Simonetti5, Marija Bje- lakovic6, Christian Gluud2 1Department of Internal Medicine, Medical Faculty, University of Nis, Nis, Serbia. 2The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. 3Gastrounit, Medical Division, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark. 4Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. 5U.O. di Medicina 2, Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy. 6Institute of Anatomy, Medical Faculty, University of Nis, Nis, Serbia Contact address: Goran Bjelakovic, Department of Internal Medicine, Medical Faculty, University of Nis, Zorana Djindjica 81, Nis, 18000, Serbia. [email protected]. Editorial group: Cochrane Metabolic and Endocrine Disorders Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 1, 2014. Review content assessed as up-to-date: 29 February 2012. Citation: Bjelakovic G, Gluud LL, Nikolova D, Whitfield K, Wetterslev J, Simonetti RG, Bjelakovic M, Gluud C. Vitamin D supplementation for prevention of mortality in adults. Cochrane Database of Systematic Reviews 2014, Issue 1. Art. No.: CD007470. DOI: 10.1002/14651858.CD007470.pub3. Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background Available evidence on the effects of vitamin D on mortality has been inconclusive. In a recent systematic review, we found evidence that vitamin D3 may decrease mortality in mostly elderly women. The present systematic review updates and reassesses the benefits and harms of vitamin D supplementation used in primary and secondary prophylaxis of mortality. Objectives To assess the beneficial and harmful effects of vitamin D supplementation for prevention of mortality in healthy adults and adults in a stable phase of disease. Search methods We searched The Cochrane Library, MEDLINE, EMBASE, LILACS, the Science Citation Index-Expanded and Conference Proceed- ings Citation Index-Science (all up to February 2012). We checked references of included trials and pharmaceutical companies for unidentified relevant trials. Selection criteria Randomised trials that compared any type of vitamin D in any dose with any duration and route of administration versus placebo or no intervention in adult participants. Participants could have been recruited from the general population or from patients diagnosed with a disease in a stable phase. Vitamin D could have been administered as supplemental vitamin D (vitamin D3 (cholecalciferol) or vitamin D2 (ergocalciferol)) or as an active form of vitamin D (1α-hydroxyvitamin D (alfacalcidol) or 1,25-dihydroxyvitamin D (calcitriol)). Vitamin D supplementation for prevention of mortality in adults (Review) 1 Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Data collection and analysis Six review authors extracted data independently. Random-effects and fixed-effect meta-analyses were conducted. For dichotomous outcomes, we calculated the risk ratios (RRs). To account for trials with zero events, we performed meta-analyses of dichotomous data using risk differences (RDs) and empirical continuity corrections. We used published data and data obtained by contacting trial authors. To minimise the risk of systematic error, we assessed the risk of bias of the included trials. Trial sequential analyses controlled the risk of random errors possibly caused by cumulative meta-analyses. Main results We identified 159 randomised clinical trials. Ninety-four trials reported no mortality, and nine trials reported mortality but did not report in which intervention group the mortality occurred. Accordingly, 56 randomised trials with 95,286 participants provided usable data on mortality. The age of participants ranged from 18 to 107 years. Most trials included women older than 70 years. The mean proportion of women was 77%. Forty-eight of the trials randomly assigned 94,491 healthy participants. Of these, four trials included healthy volunteers, nine trials included postmenopausal women and 35 trials included older people living on their own or in institutional care. The remaining eight trials randomly assigned 795 participants with neurological, cardiovascular, respiratory or rheumatoid diseases. Vitamin D was administered for a weighted mean of 4.4 years. More than half of the trials had a low risk of bias. All trials were conducted in high-income countries. Forty-five trials (80%) reported the baseline vitamin D status of participants based on serum 25-hydroxyvitamin D levels. Participants in 19 trials had vitamin D adequacy (at or above 20 ng/mL). Participants in the remaining 26 trials had vitamin D insufficiency (less than 20 ng/mL). Vitamin D decreased mortality in all 56 trials analysed together (5,920/47,472 (12.5%) vs 6,077/47,814 (12.7%); RR 0.97 (95% confidence interval (CI) 0.94 to 0.99); P = 0.02; I2 = 0%). More than 8% of participants dropped out. ’Worst-best case’ and ’best- worst case’ scenario analyses demonstrated that vitamin D could be associated with a dramatic increase or decrease in mortality. When different forms of vitamin D were assessed in separate analyses, only vitamin D3 decreased mortality (4,153/37,817 (11.0%) vs 4,340/ 2 38,110 (11.4%); RR 0.94 (95% CI 0.91 to 0.98); P = 0.002; I = 0%; 75,927 participants; 38 trials). Vitamin D2, alfacalcidol and calcitriol did not significantly affect mortality. A subgroup analysis of trials at high risk of bias suggested that vitamin D2 may even increase mortality, but this finding could be due to random errors. Trial sequential analysis supported our finding regarding vitamin D3, with the cumulative Z-score breaking the trial sequential monitoring boundary for benefit, corresponding to 150 people treated over five years to prevent one additional death. We did not observe any statistically significant differences in the effect of vitamin D on mortality in subgroup analyses of trials at low risk of bias compared with trials at high risk of bias; of trials using placebo compared with trials using no intervention in the control group; of trials with no risk of industry bias compared with trials with risk of industry bias; of trials assessing primary prevention compared with trials assessing secondary prevention; of trials including participants with vitamin D level below 20 ng/mL at entry compared with trials including participants with vitamin D levels equal to or greater than 20 ng/mL at entry; of trials including ambulatory participants compared with trials including institutionalised participants; of trials using concomitant calcium supplementation compared with trials without calcium; of trials using a dose below 800 IU per day compared with trials using doses above 800 IU per day; and of trials including only women compared with trials including both sexes or only 2 men. Vitamin D3 statistically significantly decreased cancer mortality (RR 0.88 (95% CI 0.78 to 0.98); P = 0.02; I = 0%; 44,492 participants; 4 trials). Vitamin D3 combined with calcium increased the risk of nephrolithiasis (RR 1.17 (95% CI 1.02 to 1.34); P = 0.02; I2 = 0%; 42,876 participants; 4 trials). Alfacalcidol and calcitriol increased the risk
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