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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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- N/A
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin D + fish oil placebo
- Group 2: Vitamin D placebo + fish oil
- Group 3: Vitamin D placebo + fish oil placebo
- Group 4: Vitamin D + fish oil
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.