Critical Appraisal of Large Vitamin D Randomized Controlled Trials

Nutrients

Armin Zittermann¹  Winfried März²  Nicolas D. Verheyen³  Stefan Pilz⁴  Christian Trummer⁴  Martin R. Grübler⁴  Verena Theiler-Schwetz⁴  Balazs Odler⁵  Spyridon N. Karras⁶ 

[1] Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum Nordrhein-Westfalen (NRW), Ruhr University Bochum, 32545 Bad Oeynhausen, Germany;Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, 8036 Graz, Austria;Division of Cardiology, Department of Internal Medicine, Medical University of Graz, 8036 Graz, Austria;Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, 8036 Graz, Austria;Division of Nephrology, Department of Internal Medicine, Medical University of Graz, 8036 Graz, Austria;National Scholarship Foundation, 55535 Thessaloniki, Greece;

关键词: vitamin D;    RCT;    clinical trial;    cholecalciferol;    randomized controlled trial;    epidemiology;   

DOI  :  10.3390/nu14020303

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown