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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 [OPEN ACCESS]
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Führende Autor*innen der Med Uni Graz

Pilz Stefan

Co-Autor*innen der Med Uni Graz

Grübler Martin

März Winfried

Odler Balazs

Theiler-Schwetz Verena

Trummer Christian

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)

vitamin D

RCT

clinical trial

cholecalciferol

randomized controlled trial

epidemiology

supplementation

mortality

infections

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