Vitamin D3 + Omega-3 Fatty Acids for Infections

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brigham and Women's Hospital

Stay on Your Current Meds

Trial Summary

What is the purpose of this trial?The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 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 whether vitamin D or omega-3 fatty acids affect risk of infection and plasma hCAP18 levels.

Eligibility Criteria

This trial is for participants already enrolled in the VITAL study (NCT 01169259), which includes U.S. men and women without a prior history of cancer, heart disease, or stroke.

Inclusion Criteria

Participants in VITAL (NCT 01169259)

Exclusion Criteria

Please see NCT 01169259 for lists of inclusion and exclusion criteria.

Participant Groups

The study tests if daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can reduce the risk of infections and affect hCAP18 levels in blood.

4Treatment groups

Active Control

Placebo Group

Group I: vitamin D placebo + fish oilActive Control2 Interventions

vitamin D placebo + Omacor

Group II: vitamin D + fish oilActive Control2 Interventions

vitamin D3 + Omacor

Group III: vitamin D + fish oil placeboActive Control2 Interventions

vitamin D3 + fish oil placebo

Group IV: vitamin D placebo + fish oil placeboPlacebo Group2 Interventions

vitamin D placebo + fish oil placebo