Dose Response and Efficacy Studies on the Effects of Vitamin D Supplementation on Functional Outcomes in Elderly (U01)

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The National Institute on Aging (NIA) invites applications for a clinical trial on effects of vitamin D supplementation on falls and gait speed in older individuals. During the six-year support period, the awardee will implement a randomized controlled trial with sufficient power to determine the doseresponse and efficacy of vitamin D supplementation in preventing falls, across a range of doses and baseline vitamin D levels. A measurement of effects of supplementation on gait speed should be proposed as a secondary outcome. Applicants are strongly encouraged to consider advanced, cost-efficient designs that include a dose-ranging phase followed by an efficacy phase for select doses (e.g., adaptive designs). The first nine months of the award will provide funds to conduct pilot studies to test recruitment strategies, determine the proportion of those screened who are both eligible and willing to be randomized, and finalize the study protocol, data collection forms and manual of procedures for the trial.

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