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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01704859

Enrollment

25871

Registered

2012-10-12

Start date

2018-06-01

Completion date

2022-11-23

Last updated

2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures

Keywords

fracture

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.

Interventions

DIETARY_SUPPLEMENTVitamin D3 placebo

Vitamin D placebo

DIETARY_SUPPLEMENTFish oil placebo

Fish oil placebo

DRUGomega-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_SUPPLEMENTVitamin D3

Vitamin D3 (cholecalciferol), 2000 IU per day.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Double Blind

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

All participants from the VITAL parent study (NCT01169259) were enrolled in this ancillary study.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMeryl S LeBoff, M.D.

Brigham and Women's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026