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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.
Nutr Rev 2017; 75(12):1007-1034NR

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.

Authors+Show Affiliations

School of Population Health, University of Auckland, Auckland, New Zealand.School of Population Health, University of Auckland, Auckland, New Zealand.School of Population Health, University of Auckland, Auckland, New Zealand.School of Population Health, University of Auckland, Auckland, New Zealand.

Pub Type(s)

Journal Article
Meta-Analysis
Systematic Review

Language

eng

PubMed ID

29202186

Citation

Malihi, Zarintaj, et al. "Noncalcemic Adverse Effects and Withdrawals in Randomized Controlled Trials of Long-term Vitamin D2 or D3 Supplementation: a Systematic Review and Meta-analysis." Nutrition Reviews, vol. 75, no. 12, 2017, pp. 1007-1034.
Malihi Z, Wu Z, Mm Lawes C, et al. Noncalcemic adverse effects and withdrawals in randomized controlled trials of long-term vitamin D2 or D3 supplementation: a systematic review and meta-analysis. Nutr Rev. 2017;75(12):1007-1034.
Malihi, Z., Wu, Z., Mm Lawes, C., & Scragg, R. (2017). Noncalcemic adverse effects and withdrawals in randomized controlled trials of long-term vitamin D2 or D3 supplementation: a systematic review and meta-analysis. Nutrition Reviews, 75(12), pp. 1007-1034. doi:10.1093/nutrit/nux059.
Malihi Z, et al. Noncalcemic Adverse Effects and Withdrawals in Randomized Controlled Trials of Long-term Vitamin D2 or D3 Supplementation: a Systematic Review and Meta-analysis. Nutr Rev. 2017 Dec 1;75(12):1007-1034. PubMed PMID: 29202186.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Noncalcemic adverse effects and withdrawals in randomized controlled trials of long-term vitamin D2 or D3 supplementation: a systematic review and meta-analysis. AU - Malihi,Zarintaj, AU - Wu,Zhenqiang, AU - Mm Lawes,Carlene, AU - Scragg,Robert, PY - 2017/12/5/pubmed PY - 2018/4/19/medline PY - 2017/12/5/entrez KW - adverse events KW - randomized controlled trials KW - vitamin D supplementation KW - withdrawals SP - 1007 EP - 1034 JF - Nutrition reviews JO - Nutr. Rev. VL - 75 IS - 12 N2 - 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. SN - 1753-4887 UR - https://www.unboundmedicine.com/medline/citation/29202186/Noncalcemic_adverse_effects_and_withdrawals_in_randomized_controlled_trials_of_long_term_vitamin_D2_or_D3_supplementation:_a_systematic_review_and_meta_analysis_ L2 - https://academic.oup.com/nutritionreviews/article-lookup/doi/10.1093/nutrit/nux059 DB - PRIME DP - Unbound Medicine ER -