NCT01704859

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25,871 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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 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

Detailed description

The VITAL: Vitamin D, Fractures, and Genetic Markers is an ancillary study of the parent VITAL trial (VITamin D and OmegA-3 TriaL). The study will require the adjudication of all self-reported incident fracture events among 25,871 men and women. Findings from this ancillary study will inform clinical practice on the role(s) of vitamin D supplements in fracture prevention. This proposal will generate important positive or informative negative results about effects of supplemental vitamin D3 alone on fracture risk, while also elucidating the relative importance of vitamin D biomarkers and genetic variations in vitamin D-related pathways on bone. Findings from the proposed ancillary study have the potential for major clinical as well as public health impact for both men and women in the U.S.

Conditions

• Fractures

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D3 placebo	Vitamin D placebo
DIETARY_SUPPLEMENT	Fish oil placebo	Fish oil placebo
DRUG	omega-3 fatty acids (fish oil)	Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
DIETARY_SUPPLEMENT	Vitamin D3	Vitamin D3 (cholecalciferol), 2000 IU per day.

Timeline

• Start date: 2018-06-01
• Primary completion: 2022-03-31
• Completion: 2022-11-23
• First posted: 2012-10-12
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States