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Omega-3 Fatty Acids

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

N/A

Waitlist Available

Led By Debra A Schaumberg, ScD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Summary

This trial is studying whether vitamins D & omega-3, compared to a placebo, can reduce the risk of cancer, heart disease, stroke & age-related macular degeneration.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include mild digestive discomfort from fish oil or an increased calcium level due to vitamin D supplementation; however, serious side effects are rare with these over-the-counter supplements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With an AMD Event

Secondary study objectives

Number of Participants With Incident Visually-Significant AMD

Other study objectives

Number of Participants With AMD Progression

Number of Participants With Incident AMD

Number of Participants With an AMD Event, Excluding the First Two Years of Follow-up

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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

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