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

Mass General Brigham

Status: Unknown

Conditions: Dry Eye Disease

Treatments: Drug: Omega-3 fatty acids (fish oil); Dietary Supplement: Vitamin D3 placebo; Drug: Fish oil placebo; Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01880463

R01EY022663 (U.S. NIH Grant/Contract)

2012P001332

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25,875 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

25,875 participants in 4 patient groups, including a placebo group

Vitamin D + fish oil placebo

Active Comparator group

Description:

Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo

Treatment:

Drug: Fish oil placebo

Dietary Supplement: Vitamin D3

Vitamin D placebo + fish oil

Active Comparator group

Description:

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 \[DHA\])

Treatment:

Dietary Supplement: Vitamin D3 placebo

Drug: Omega-3 fatty acids (fish oil)

Vitamin D placebo + fish oil placebo

Placebo Comparator group

Description:

Vitamin D placebo fish oil placebo

Treatment:

Drug: Fish oil placebo

Dietary Supplement: Vitamin D3 placebo

Vitamin D + fish oil

Active Comparator group

Description:

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 \[DHA\])

Treatment:

Dietary Supplement: Vitamin D3

Drug: Omega-3 fatty acids (fish oil)