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

NCT01880463 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25875

Last updated 2019-07-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Omega-3 fatty acids (fish oil)

DIETARY_SUPPLEMENT

Vitamin D3

DIETARY_SUPPLEMENT

Vitamin D3 placebo

DRUG

Fish oil placebo

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2020-12-31
Completion
2021-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01880463 on ClinicalTrials.gov