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

Overview

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2019

Detailed Description

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.

Interventions

  • Drug: Omega-3 fatty acids (fish oil)
  • Dietary Supplement: Vitamin D3
  • Dietary Supplement: Vitamin D3 placebo
  • Dietary Supplement: Fish oil placebo

Arms, Groups and Cohorts

  • Active Comparator: Vitamin D + fish oil placebo
    • Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo
  • Active Comparator: Vitamin D placebo + fish oil
    • 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])
  • Placebo Comparator: Vitamin D placebo + fish oil placebo
    • Vitamin D placebo fish oil placebo
  • Active Comparator: Vitamin D + fish oil
    • 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])

Clinical Trial Outcome Measures

Primary Measures

  • Age-related macular degeneration
    • Time Frame: 5 years
    • Report of a diagnosis of age-related macular degeneration confirmed by medical record review.

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

  • None

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Collaborator
    • National Eye Institute (NEI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: William G. Christen, Associate Professor – Brigham and Women’s Hospital
  • Overall Official(s)
    • Debra A Schaumberg, ScD, Principal Investigator, Brigham and Women’s Hospital
    • William G Christen, ScD, Principal Investigator, Brigham and Women’s Hospital

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