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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25875 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)

NCT01782352

Age-related Macular Degeneration

UNKNOWN NA

VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL

NCT01696435

Depression Depressive Symptoms Mood

COMPLETED NA

Effects of Vitamin D and Omega-3 Supplementation on Telomeres in VITAL

NCT04386577

Aging

UNKNOWN PHASE3

VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone (VITAL)

NCT04573946

Bone Density Bone Health Fractures

ACTIVE_NOT_RECRUITING NA

Vitamin D and Omega-3 Hypertension Trial (VITAL Hypertension)

NCT01653678

Hypertension

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin D + fish oil placebo

Vitamin D3 (cholecalciferol), 2000 IU per day

Fish oil placebo

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Fish oil placebo

Intervention Type DRUG

Vitamin D placebo + 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 \[DHA\])

Group Type ACTIVE_COMPARATOR

Omega-3 fatty acids (fish oil)

Intervention Type DRUG

Vitamin D3 placebo

Intervention Type DIETARY_SUPPLEMENT

Vitamin D placebo + fish oil placebo

Vitamin D placebo

fish oil placebo

Group Type PLACEBO_COMPARATOR

Vitamin D3 placebo

Intervention Type DIETARY_SUPPLEMENT

Fish oil placebo

Intervention Type DRUG

Vitamin D + 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 \[DHA\])

Group Type ACTIVE_COMPARATOR