Vitamin D + Omega-3 for Preventing Major Diseases

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must be taking: Vitamin D3, Omega-3

Disqualifiers: Cancer, Heart disease, Stroke, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

25871 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Meryl S LeBoff, M.D.

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for U.S. men and women who were part of the VITAL parent study, looking at whether daily supplements of vitamin D3 or omega-3 fatty acids can prevent cancer, heart disease, and stroke in those without a history of these conditions.

Inclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) to assess their impact on fracture risk

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on incident total, non-vertebral, and hip fractures

6 months

Treatment Details

Interventions

• Fish Oil
• Vitamin D3

Trial Overview The study tests if taking vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram) daily reduces the risk of broken bones. It also explores if vitamin D's effect on bone fractures is influenced by genetic factors related to vitamin D levels.

Participant Groups

Group I: Vitamin D + fish oil placebo Active Control 2 Interventions

Group II: Vitamin D placebo + fish oil Active Control 2 Interventions

Group III: Vitamin D + fish oil Active Control 2 Interventions

Group IV: Vitamin D placebo + fish oil placebo Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+