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Noncalcemic adverse effects and withdrawals in randomized controlled trials of long-term vitamin D2 or D3 supplementation: a systematic review and meta-analysis

Abstract Context Recent randomized controlled trials (RCTs) provide evidence for a possible beneficial impact of vitamin D supplementation on health outcomes beyond bone health, but there are few reviews of noncalcemic adverse effects from long-term supplementation. Objective The aims of this system... Full description

Journal Title: Nutrition reviews 2017, Vol.75 (12), p.1007-1034
Main Author: Malihi, Zarintaj
Other Authors: Wu, Zhenqiang , MM Lawes, Carlene , Scragg, Robert
Format: Electronic Article Electronic Article
Language: English
Subjects:
Publisher: United States: Oxford University Press
ID: ISSN: 0029-6643
Link: https://www.ncbi.nlm.nih.gov/pubmed/29202186
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recordid: cdi_crossref_primary_10_1093_nutrit_nux059
title: Noncalcemic adverse effects and withdrawals in randomized controlled trials of long-term vitamin D2 or D3 supplementation: a systematic review and meta-analysis
format: Article
creator:
  • Malihi, Zarintaj
  • Wu, Zhenqiang
  • MM Lawes, Carlene
  • Scragg, Robert
subjects:
  • Adult
  • Aged
  • Aged, 80 and over
  • Bone and Bones - drug effects
  • Calcium, Dietary - administration & dosage
  • Cholecalciferol - administration & dosage
  • Cholecalciferol - adverse effects
  • Dietary Supplements - adverse effects
  • Ergocalciferols - administration & dosage
  • Ergocalciferols - adverse effects
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Dropouts
  • Randomized Controlled Trials as Topic
  • Vitamin D - administration & dosage
  • Vitamin D - adverse effects
  • Vitamins - administration & dosage
  • Vitamins - adverse effects
  • Young Adult
ispartof: Nutrition reviews, 2017, Vol.75 (12), p.1007-1034
description: Abstract Context Recent randomized controlled trials (RCTs) provide evidence for a possible beneficial impact of vitamin D supplementation on health outcomes beyond bone health, but there are few reviews of noncalcemic adverse effects from long-term supplementation. Objective The aims of this systematic review of vitamin D supplementation in RCTs were as follows: to determine whether all adverse effects, when combined, are reported equally between treatment arms; to identify the most common noncalcemic adverse effects reported; and to ascertain whether withdrawal rates, as a marker of clinical adverse effects, differ between treatment arms. Data Sources The MEDLINE Ovid, Embase, and Cochrane Library databases were searched systematically up to May 2016. Study Selection Randomized controlled trials that met the following criteria were selected: administered vitamin D2 or D3 supplements for a minimum supplementation or follow-up period of 24 weeks, had a placebo/control group, and were conducted among adults (≥ 18 y). Data Extraction Two researchers independently screened studies for eligibility, extracted data, and carried out quality assessment of selected studies. A total of 128 studies with 52 297 participants were identified. A random-effects model was used to calculate risk ratios in a meta-analysis. Results Long-term vitamin D2 or D3 supplementation, compared with placebo, did not increase all adverse effects, when combined, as reported in 62 studies with 19 389 participants (relative risk [RR] = 0.97; 95%CI, 0.92–1.02). Vitamin D also did not increase the risk of the most common noncalcemic adverse effects: gastrointestinal symptoms were reported in 27 studies with 9189 participants (RR = 1.01; 95%CI, 0.87–1.17), and dermatological symptoms were reported in 8 studies with 1695 participants (RR = 1.33; 95%CI, 0.82–2.15). Vitamin D did not increase withdrawals from 123 studies with 41 861 participants (RR = 1.03; 95%CI, 0.96–1.09). However, participants given vitamin D were more likely to report withdrawals than those given placebo in studies in which calcium was given in both arms (RR = 1.16; 95%CI, 1.02–1.33) when compared with participants in studies in which calcium was not given in either arm (RR = 1.00; 95%CI, 0.95–1.06; P for interaction = 0.009). Conclusions Overall, these findings suggest that vitamin D, by itself, does not increase the risk of noncalcemic adverse effects.
language: eng
source:
identifier: ISSN: 0029-6643
fulltext: no_fulltext
issn:
  • 0029-6643
  • 1753-4887
url: Link


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titleNoncalcemic adverse effects and withdrawals in randomized controlled trials of long-term vitamin D2 or D3 supplementation: a systematic review and meta-analysis
creatorMalihi, Zarintaj ; Wu, Zhenqiang ; MM Lawes, Carlene ; Scragg, Robert
creatorcontribMalihi, Zarintaj ; Wu, Zhenqiang ; MM Lawes, Carlene ; Scragg, Robert
descriptionAbstract Context Recent randomized controlled trials (RCTs) provide evidence for a possible beneficial impact of vitamin D supplementation on health outcomes beyond bone health, but there are few reviews of noncalcemic adverse effects from long-term supplementation. Objective The aims of this systematic review of vitamin D supplementation in RCTs were as follows: to determine whether all adverse effects, when combined, are reported equally between treatment arms; to identify the most common noncalcemic adverse effects reported; and to ascertain whether withdrawal rates, as a marker of clinical adverse effects, differ between treatment arms. Data Sources The MEDLINE Ovid, Embase, and Cochrane Library databases were searched systematically up to May 2016. Study Selection Randomized controlled trials that met the following criteria were selected: administered vitamin D2 or D3 supplements for a minimum supplementation or follow-up period of 24 weeks, had a placebo/control group, and were conducted among adults (≥ 18 y). Data Extraction Two researchers independently screened studies for eligibility, extracted data, and carried out quality assessment of selected studies. A total of 128 studies with 52 297 participants were identified. A random-effects model was used to calculate risk ratios in a meta-analysis. Results Long-term vitamin D2 or D3 supplementation, compared with placebo, did not increase all adverse effects, when combined, as reported in 62 studies with 19 389 participants (relative risk [RR] = 0.97; 95%CI, 0.92–1.02). Vitamin D also did not increase the risk of the most common noncalcemic adverse effects: gastrointestinal symptoms were reported in 27 studies with 9189 participants (RR = 1.01; 95%CI, 0.87–1.17), and dermatological symptoms were reported in 8 studies with 1695 participants (RR = 1.33; 95%CI, 0.82–2.15). Vitamin D did not increase withdrawals from 123 studies with 41 861 participants (RR = 1.03; 95%CI, 0.96–1.09). However, participants given vitamin D were more likely to report withdrawals than those given placebo in studies in which calcium was given in both arms (RR = 1.16; 95%CI, 1.02–1.33) when compared with participants in studies in which calcium was not given in either arm (RR = 1.00; 95%CI, 0.95–1.06; P for interaction = 0.009). Conclusions Overall, these findings suggest that vitamin D, by itself, does not increase the risk of noncalcemic adverse effects.
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subjectAdult ; Aged ; Aged, 80 and over ; Bone and Bones - drug effects ; Calcium, Dietary - administration & dosage ; Cholecalciferol - administration & dosage ; Cholecalciferol - adverse effects ; Dietary Supplements - adverse effects ; Ergocalciferols - administration & dosage ; Ergocalciferols - adverse effects ; Female ; Humans ; Male ; Middle Aged ; Patient Dropouts ; Randomized Controlled Trials as Topic ; Vitamin D - administration & dosage ; Vitamin D - adverse effects ; Vitamins - administration & dosage ; Vitamins - adverse effects ; Young Adult
ispartofNutrition reviews, 2017, Vol.75 (12), p.1007-1034
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0The Author(s) 2017. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com 2017
1The Author(s) 2017. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com
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descriptionAbstract Context Recent randomized controlled trials (RCTs) provide evidence for a possible beneficial impact of vitamin D supplementation on health outcomes beyond bone health, but there are few reviews of noncalcemic adverse effects from long-term supplementation. Objective The aims of this systematic review of vitamin D supplementation in RCTs were as follows: to determine whether all adverse effects, when combined, are reported equally between treatment arms; to identify the most common noncalcemic adverse effects reported; and to ascertain whether withdrawal rates, as a marker of clinical adverse effects, differ between treatment arms. Data Sources The MEDLINE Ovid, Embase, and Cochrane Library databases were searched systematically up to May 2016. Study Selection Randomized controlled trials that met the following criteria were selected: administered vitamin D2 or D3 supplements for a minimum supplementation or follow-up period of 24 weeks, had a placebo/control group, and were conducted among adults (≥ 18 y). Data Extraction Two researchers independently screened studies for eligibility, extracted data, and carried out quality assessment of selected studies. A total of 128 studies with 52 297 participants were identified. A random-effects model was used to calculate risk ratios in a meta-analysis. Results Long-term vitamin D2 or D3 supplementation, compared with placebo, did not increase all adverse effects, when combined, as reported in 62 studies with 19 389 participants (relative risk [RR] = 0.97; 95%CI, 0.92–1.02). Vitamin D also did not increase the risk of the most common noncalcemic adverse effects: gastrointestinal symptoms were reported in 27 studies with 9189 participants (RR = 1.01; 95%CI, 0.87–1.17), and dermatological symptoms were reported in 8 studies with 1695 participants (RR = 1.33; 95%CI, 0.82–2.15). Vitamin D did not increase withdrawals from 123 studies with 41 861 participants (RR = 1.03; 95%CI, 0.96–1.09). However, participants given vitamin D were more likely to report withdrawals than those given placebo in studies in which calcium was given in both arms (RR = 1.16; 95%CI, 1.02–1.33) when compared with participants in studies in which calcium was not given in either arm (RR = 1.00; 95%CI, 0.95–1.06; P for interaction = 0.009). Conclusions Overall, these findings suggest that vitamin D, by itself, does not increase the risk of noncalcemic adverse effects.
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abstractAbstract Context Recent randomized controlled trials (RCTs) provide evidence for a possible beneficial impact of vitamin D supplementation on health outcomes beyond bone health, but there are few reviews of noncalcemic adverse effects from long-term supplementation. Objective The aims of this systematic review of vitamin D supplementation in RCTs were as follows: to determine whether all adverse effects, when combined, are reported equally between treatment arms; to identify the most common noncalcemic adverse effects reported; and to ascertain whether withdrawal rates, as a marker of clinical adverse effects, differ between treatment arms. Data Sources The MEDLINE Ovid, Embase, and Cochrane Library databases were searched systematically up to May 2016. Study Selection Randomized controlled trials that met the following criteria were selected: administered vitamin D2 or D3 supplements for a minimum supplementation or follow-up period of 24 weeks, had a placebo/control group, and were conducted among adults (≥ 18 y). Data Extraction Two researchers independently screened studies for eligibility, extracted data, and carried out quality assessment of selected studies. A total of 128 studies with 52 297 participants were identified. A random-effects model was used to calculate risk ratios in a meta-analysis. Results Long-term vitamin D2 or D3 supplementation, compared with placebo, did not increase all adverse effects, when combined, as reported in 62 studies with 19 389 participants (relative risk [RR] = 0.97; 95%CI, 0.92–1.02). Vitamin D also did not increase the risk of the most common noncalcemic adverse effects: gastrointestinal symptoms were reported in 27 studies with 9189 participants (RR = 1.01; 95%CI, 0.87–1.17), and dermatological symptoms were reported in 8 studies with 1695 participants (RR = 1.33; 95%CI, 0.82–2.15). Vitamin D did not increase withdrawals from 123 studies with 41 861 participants (RR = 1.03; 95%CI, 0.96–1.09). However, participants given vitamin D were more likely to report withdrawals than those given placebo in studies in which calcium was given in both arms (RR = 1.16; 95%CI, 1.02–1.33) when compared with participants in studies in which calcium was not given in either arm (RR = 1.00; 95%CI, 0.95–1.06; P for interaction = 0.009). Conclusions Overall, these findings suggest that vitamin D, by itself, does not increase the risk of noncalcemic adverse effects.
copUnited States
pubOxford University Press
pmid29202186
doi10.1093/nutrit/nux059