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

Not Applicable

Completed

• Conditions: Fractures
• Interventions: Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: Fish oil placebo; Drug: omega-3 fatty acids (fish oil); Dietary Supplement: Vitamin D3

• Registration Number: NCT01704859
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-09
• Study First Posted: 2012-10-12
• Study Start: 2018-06-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-11-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25871

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vitamin D placebo + fish oil placebo	Vitamin D3 placebo	-
Vitamin D placebo + fish oil placebo	Fish oil placebo	-
Vitamin D placebo + fish oil	Vitamin D3 placebo	-
Vitamin D placebo + fish oil	omega-3 fatty acids (fish oil)	-
Vitamin D + fish oil placebo	Fish oil placebo	-
Vitamin D + fish oil placebo	Vitamin D3	-
Vitamin D + fish oil	omega-3 fatty acids (fish oil)	-
Vitamin D + fish oil	Vitamin D3	-

Primary Outcome Measures

Name	Time	Method
Incident total, non-vertebral, and hip fractures	5 years	To determine whether vitamin D supplementation will reduce incident total, non-vertebral, and hip fractures according to annual questionnaires, medical record review, and fracture adjudication.

Secondary Outcome Measures

Name	Time	Method
Incident total, non-vertebral, and hip fractures	5 years	To determine whether baseline vitamin D levels and genetic variation in vitamin D-related pathways modify effects of vitamin D supplements on fractures.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States