Vitamin D + Omega-3 for Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

Overseen byDebra A Schaumberg, ScD

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 a 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, compared to placebo, reduce the incidence and/or progression of age-related macular degeneration (AMD).

Eligibility Criteria

This trial is for U.S. men and women who are part of the VITAL study, looking at whether daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram) can prevent cancer, heart disease, and stroke in those without a history of these conditions. It focuses on age-related macular degeneration.

Inclusion Criteria

All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.

Exclusion Criteria

N/A

Participant Groups

The trial tests if taking daily dietary supplements—either vitamin D3 (2000 IU) or omega-3 fatty acids from fish oil (1 gram)—can reduce the risk or slow down the progression of age-related macular degeneration compared to placebo.

4Treatment groups

Active Control

Placebo Group

Group I: Vitamin D + fish oil placeboActive Control2 Interventions

Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo

Group II: Vitamin D placebo + fish oilActive Control2 Interventions

Vitamin D placebo 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 \[DHA\])

Group III: Vitamin D + fish oilActive Control2 Interventions

Vitamin D (cholecalciferol), 2000 IU per day 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 \[DHA\])

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

Vitamin D placebo fish oil placebo