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Critical appraisal of large vitamin D randomized controlled trials

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 conduct...

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Main Authors: Pilz, Stefan (Author) , Trummer, Christian (Author) , Theiler-Schwetz, Verena (Author) , Grübler, Martin R. (Author) , Verheyen, Nicolas (Author) , Odler, Balazs (Author) , Karras, Spyridon N. (Author) , Zittermann, Armin (Author) , März, Winfried (Author)
Format: Article (Journal)
Language:English
Published: 12 January 2022
In: Nutrients
Year: 2022, Volume: 14, Issue: 2, Pages: 1-14
ISSN:2072-6643
DOI:10.3390/nu14020303
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.3390/nu14020303
Verlag, kostenfrei, Volltext: https://www.mdpi.com/2072-6643/14/2/303
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Author Notes:Stefan Pilz, Christian Trummer, Verena Theiler-Schwetz, Martin R. Grübler, Nicolas D. Verheyen, Balazs Odler, Spyridon N. Karras, Armin Zittermann and Winfried März

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520 |a 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. 
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