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随机对照试验是唯一能够证明维生素 D 在健康中所起作用的恰当方法。

RCTS are the only appropriate way to demonstrate the role of vitamin D in health.

机构信息

Tromsø Endocrine Research Group, Institute of Clinical Medicine, UiT The Arctic University of Norway, 9037 Tromsø, Norway; Division of Internal Medicine, The University Hospital of North Norway, 9038 Tromsø, Norway.

出版信息

J Steroid Biochem Mol Biol. 2018 Mar;177:10-14. doi: 10.1016/j.jsbmb.2017.05.004. Epub 2017 May 5.

Abstract

Despite thousands of vitamin D studies published, including hundreds of reviews and meta-analyses, it is still uncertain if supplementation with vitamin D will have positive health effects, except for the skeleton. This cannot be answered by doing more observational studies as it is impossible to control for confounding factors and reverse causality. The only way to firmly prove positive vitamin D effects is by doing the properly designed randomized controlled trials (RCTs). However, it has been difficult to show the expected positive effects by vitamin D supplementation in RCTs, which may indicate that the effects, if present must be small. On the other hand, results from Mendelian randomization studies have shown promising results at least for mortality and multiple sclerosis. In the near future, results from several large RCTs with hard endpoints will be available. If these show positive results, the main question on vitamin D and health is answered. If they turn out negative, they will be criticized for having included subjects without vitamin D deficiency, and some studies might not have used an optimal dosing regimen. New and better-designed RCTs will then be needed, but will be very hard to perform.

摘要

尽管已经发表了数千项维生素 D 研究,包括数百项综述和荟萃分析,但除了骨骼之外,补充维生素 D 是否会对健康产生积极影响仍不确定。由于无法控制混杂因素和反向因果关系,因此进行更多观察性研究也无法回答这个问题。唯一能确定维生素 D 具有积极效果的方法是进行精心设计的随机对照试验 (RCT)。然而,在 RCT 中,通过维生素 D 补充很难显示出预期的积极效果,这可能表明如果存在效果,其必须很小。另一方面,孟德尔随机化研究的结果至少在死亡率和多发性硬化症方面显示出有希望的结果。在不久的将来,将有几项具有硬性终点的大型 RCT 的结果可供参考。如果这些结果显示出积极的结果,那么关于维生素 D 和健康的主要问题将得到解答。如果结果为阴性,人们将批评这些研究纳入了没有维生素 D 缺乏的受试者,并且一些研究可能没有使用最佳剂量方案。然后,将需要新的和设计更好的 RCT,但这将非常困难。

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