Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)
2 other identifiers
interventional
25,875
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2010
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 15, 2013
CompletedFirst Posted
Study publicly available on registry
June 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJuly 30, 2019
July 1, 2019
10.4 years
June 15, 2013
July 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dry Eye Disease
Report of a diagnosis of dry eye disease confirmed by medical record review.
5 years
Study Arms (4)
Vitamin D + fish oil placebo
ACTIVE COMPARATORVitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo
Vitamin D placebo + fish oil
ACTIVE COMPARATORVitamin 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
PLACEBO COMPARATORVitamin D placebo fish oil placebo
Vitamin D + fish oil
ACTIVE COMPARATORVitamin 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 \[DHA\])
Interventions
Eligibility Criteria
You may qualify if:
- All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- National Eye Institute (NEI)collaborator
Related Publications (1)
Christen WG, Cook NR, Manson JE, Buring JE, Lee IM, Bubes V, Friedenberg G, Dushkes R, Smith D, Schaumberg DA; VITAL Research Group. Efficacy of Marine omega-3 Fatty Acid Supplementation vs Placebo in Reducing Incidence of Dry Eye Disease in Healthy US Adults: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 Jul 1;140(7):707-714. doi: 10.1001/jamaophthalmol.2022.1818.
PMID: 35679030DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 15, 2013
First Posted
June 19, 2013
Study Start
July 1, 2010
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
July 30, 2019
Record last verified: 2019-07