Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)
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|
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.
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
Dry Eye Disease
time frame: 5 years
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:
|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.|
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