Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)

Study Overview
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Brief Summary
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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).

Detailed Description
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This ancillary study to the VITamin D and OmegA-3 TriaL (VITAL) will examine whether vitamin D3 and omega-3 fatty acids can help prevent the onset or progression of age-related macular degeneration (AMD). The study will also examine whether vitamin D3 and omega-3 fatty acids interact with each other, or with specific genes associated with AMD or vitamin D3 or omega-3 fatty acid metabolic activity, to affect the risk of developing AMD.

Official Title
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Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)

Conditions
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Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Omega-3 fatty acids (fish oil)
* Dietary Supplement: Vitamin D3
* Dietary Supplement: Vitamin D3 placebo
* Dietary Supplement: Fish oil placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D + fish oil placebo<br>Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo | Dietary Supplement: Vitamin D3<br> <br> * Other names: cholecalciferol;Dietary Supplement: Fish oil placebo<br> <br> |
| Active Comparator: Vitamin D placebo + fish oil<br>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]) | Drug: Omega-3 fatty acids (fish oil)<br> <br> * Other names: Omacor;Dietary Supplement: Vitamin D3 placebo<br> <br> |
| Placebo Comparator: Vitamin D placebo + fish oil placebo<br>Vitamin D placebo fish oil placebo | Dietary Supplement: Vitamin D3 placebo<br> <br> Dietary Supplement: Fish oil placebo<br> <br> |
| Active Comparator: Vitamin D + fish oil<br>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]) | Drug: Omega-3 fatty acids (fish oil)<br> <br> * Other names: Omacor;Dietary Supplement: Vitamin D3<br> <br> * Other names: cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With an AMD Event | AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Incident Visually-Significant AMD | AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse | 5 years | 
| Number of Participants With Incident Advanced AMD |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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age-related macular degeneration, incidence, progression