Overview

This trial is active, not recruiting.

Condition dry eye disease
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 NCT01880463, 2012P001332, R01EY022663

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 omega-3 fatty acids or vitamin D3, compared to placebo, reduce the incidence and/or progression of dry eye disease.

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
Dry Eye Disease
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 Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)
Description This ancillary study to VITAL will examine the efficacy of omega-3 fatty acids and vitamin D3 in prevention of dry eye disease. The primary aims are to test whether omega-3 fatty acid supplementation (1) reduces the incidence of dry eye disease, and (2) improves the natural history of dry eye disease by relieving symptoms and other impacts on quality of life. Secondary aims are to estimate the incidence of dry eye disease in the US, prospectively examine the natural history of dry disease, explore factors that could modify or influence the impact of omega-3 fatty acid supplementation, evaluate the interrelationship of dry eye disease and depression, and test for possible independent or joint effects of vitamin D3 supplementation in the incidence and natural history of dry eye disease.
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.