Overview

This trial is active, not recruiting.

Condition age-related macular degeneration
Treatments omega-3 fatty acids (fish oil), vitamin d3, vitamin d3 placebo, fish oil placebo
Sponsor Brigham and Women's Hospital
Collaborator National Eye Institute (NEI)
Start date July 2010
End date October 2017
Trial size 25875 participants
Trial identifier NCT01782352, 2012P000724, 2012P001797, R01EY021900

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo
vitamin d3 cholecalciferol
fish oil placebo
(Active Comparator)
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])
omega-3 fatty acids (fish oil) Omacor
vitamin d3 placebo
(Placebo Comparator)
Vitamin D placebo fish oil placebo
vitamin d3 placebo
fish oil placebo
(Active Comparator)
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])
omega-3 fatty acids (fish oil) Omacor
vitamin d3 cholecalciferol

Primary Outcomes

Measure
Age-related macular degeneration
time frame: 5 years

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Exclusion Criteria:

Additional Information

Official title Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)
Principal investigator Debra A Schaumberg, ScD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.