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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 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

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)NIH
556 Previous Clinical Trials
1,381,599 Total Patients Enrolled
78 Trials studying Macular Degeneration
46,801 Patients Enrolled for Macular Degeneration
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,817,595 Total Patients Enrolled
1 Trials studying Macular Degeneration
21,442 Patients Enrolled for Macular Degeneration
Debra A Schaumberg, ScDPrincipal InvestigatorBrigham and Women's Hospital
William G Christen, ScDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Omega-3 fatty acids (fish oil) (Omega-3 Fatty Acids) Clinical Trial Eligibility Overview. Trial Name: NCT01782352 — N/A
Macular Degeneration Research Study Groups: Vitamin D + fish oil placebo, Vitamin D placebo + fish oil, Vitamin D placebo + fish oil placebo, Vitamin D + fish oil
Macular Degeneration Clinical Trial 2023: Omega-3 fatty acids (fish oil) Highlights & Side Effects. Trial Name: NCT01782352 — N/A
Omega-3 fatty acids (fish oil) (Omega-3 Fatty Acids) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01782352 — N/A
~1678 spots leftby Dec 2025