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Pilz, S; Trummer, C; Theiler-Schwetz, V; Grübler, MR; Verheyen, ND; Odler, B; Karras, SN; Zittermann, A; März, W.
Critical Appraisal of Large Vitamin D Randomized Controlled Trials.
Nutrients. 2022; 14(2):
Doi: 10.3390/nu14020303
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- Leading authors Med Uni Graz
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Pilz Stefan
- Co-authors Med Uni Graz
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Grübler Martin
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März Winfried
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Odler Balazs
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Theiler-Schwetz Verena
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Trummer Christian
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Verheyen Nicolas Dominik
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- Abstract:
- As a consequence of epidemiological studies showing significant associations of vitamin D deficiency with a variety of adverse extra-skeletal clinical outcomes including cardiovascular diseases, cancer, and mortality, large vitamin D randomized controlled trials (RCTs) have been designed and conducted over the last few years. The vast majority of these trials did not restrict their study populations to individuals with vitamin D deficiency, and some even allowed moderate vitamin D supplementation in the placebo groups. In these RCTs, there were no significant effects on the primary outcomes, including cancer, cardiovascular events, and mortality, but explorative outcome analyses and meta-analyses revealed indications for potential benefits such as reductions in cancer mortality or acute respiratory infections. Importantly, data from RCTs with relatively high doses of vitamin D supplementation did, by the vast majority, not show significant safety issues, except for trials in critically or severely ill patients or in those using very high intermittent vitamin D doses. The recent large vitamin D RCTs did not challenge the beneficial effects of vitamin D regarding rickets and osteomalacia, that therefore continue to provide the scientific basis for nutritional vitamin D guidelines and recommendations. There remains a great need to evaluate the effects of vitamin D treatment in populations with vitamin D deficiency or certain characteristics suggesting a high sensitivity to treatment. Outcomes and limitations of recently published large vitamin D RCTs must inform the design of future vitamin D or nutrition trials that should use more personalized approaches.
- Find related publications in this database (Keywords)
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vitamin D
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RCT
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clinical trial
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cholecalciferol
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randomized controlled trial
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epidemiology
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supplementation
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mortality
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infections