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

Not Applicable

• Conditions: Dry Eye Disease
• Interventions: Drug: Omega-3 fatty acids (fish oil); Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: Vitamin D3; Drug: Fish oil placebo

• Registration Number: NCT01880463
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2013-06-15
• Study First Submitted QC: 2013-06-15
• Study First Posted: 2013-06-19
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-27
• Last Update Posted: 2019-07-30
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25875

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vitamin D placebo + fish oil	Omega-3 fatty acids (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 \[DHA\])
Vitamin D placebo + fish oil	Vitamin D3 placebo	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 \[DHA\])
Vitamin D placebo + fish oil placebo	Vitamin D3 placebo	Vitamin D placebo fish oil placebo
Vitamin D + fish oil	Omega-3 fatty acids (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 \[DHA\])
Vitamin D + fish oil	Vitamin D3	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 \[DHA\])
Vitamin D placebo + fish oil placebo	Fish oil placebo	Vitamin D placebo fish oil placebo
Vitamin D + fish oil placebo	Vitamin D3	Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo
Vitamin D + fish oil placebo	Fish oil placebo	Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo

Primary Outcome Measures

Name	Time	Method
Dry Eye Disease	5 years	Report of a diagnosis of dry eye disease confirmed by medical record review.