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VITamin D and OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic Markers

ClinicalTrials.gov · COMPLETED, 2022

25,871 participants

Abstract

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine (1) whether vitamin D reduces incident total, non-vertebral fractures, and hip fractures and (2) whether this reduction is modified by vitamin D levels

Conditions: Fractures.

Primary outcome: Incident total, non-vertebral, and hip fractures.

Enrollment: 25871 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 25,871 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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