CompletedNot Applicable

VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL)

United States771 participantsStarted 2012-08

Plain-language summary

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 fish oil (1 gram of omega-3 fatty acids) 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 a sub-cohort of 771 participants in VITAL and will test the efficacy and safety of high-dose vitamin D supplementation vs. placebo on skeletal health and body composition.

Who can participate

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study: * Those who are using bisphosphonates currently or within the past 2 years, or other bone-active medications currently or within the past year are not eligible for this study.

What they're measuring

Change in Bone Density

Timeframe: 2 years

Bone Turnover P1NP

Timeframe: 2 years

Bone Turnover Beta Crosslaps

Timeframe: 2 years

Trial details

NCT IDNCT01747447

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

Results submitted2021-01-20

View on ClinicalTrials.gov More Bone Density trials