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

Detailed Description
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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.

Official Title
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Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: Omega-3 fatty acids (fish oil)
* Dietary Supplement: Vitamin D3
* Dietary Supplement: Vitamin D3 placebo
* Drug: 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;Drug: 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> Drug: 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 |
| --- | --- | --- |
| Dry Eye Disease | Report of a diagnosis of dry eye disease confirmed by medical record review. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye disease, incidence, progression