April 6, 2011

A Potential Design Flaw of Randomized Trials of Vitamin Supplements

Author Affiliations

Author Affiliations: Section on Nutrition and Nutritional Epidemiology, Department of Internal Medicine (Dr Morris), and Department of Clinical Nutrition (Dr Tangney), Rush University Medical Center, Chicago, Illinois.

JAMA. 2011;305(13):1348-1349. doi:10.1001/jama.2011.383

What are scientists, physicians, and the general public to make of the many null findings from randomized controlled trials (RCTs) of vitamin supplements? These trials are usually conducted on the basis of positive findings from prospective epidemiological studies and laboratory evidence of biological mechanisms. A common view is that the negative findings from the RCTs offer incontrovertible evidence that the nutrient is unrelated to disease and that the epidemiological studies are biased. An alternative explanation is that most RCTs of vitamin supplements are designed to test the hypothesis that supplementation, no matter the nutrient status, is protective. Vitamin treatment may not be effective in these trials because nutrient intake among the participants is already at optimum levels. To specify, examples are provided from the field of dementia and investigations of 3 dietary components: vitamin E, B vitamins, and docosahexaenoic acid.

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