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

Mass General Brigham

Status: Completed

Conditions: Fractures

Treatments: Dietary Supplement: Vitamin D3; Drug: omega-3 fatty acids (fish oil); Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: Fish oil placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01704859

1R01AR070854-01A1 (U.S. NIH Grant/Contract)

2010P002005

Details and patient eligibility

About

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

Full 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.

Enrollment: 25,871 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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25,871 participants in 4 patient groups, including a placebo group

Vitamin D placebo + fish oil placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Fish oil placebo

Dietary Supplement: Vitamin D3 placebo

Vitamin D placebo + fish oil

Active Comparator group

Treatment:

Drug: omega-3 fatty acids (fish oil)

Dietary Supplement: Vitamin D3 placebo

Vitamin D + fish oil placebo

Active Comparator group

Treatment:

Dietary Supplement: Fish oil placebo

Dietary Supplement: Vitamin D3

Vitamin D + fish oil

Active Comparator group

Treatment:

Drug: omega-3 fatty acids (fish oil)

Dietary Supplement: Vitamin D3