- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01880463
Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Vitamin D + fish oil placebo
Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo |
Other Names:
|
Active Comparator: 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]) |
Other Names:
|
Placebo Comparator: Vitamin D placebo + fish oil placebo
Vitamin D placebo fish oil placebo |
|
Active Comparator: 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]) |
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dry Eye Disease
Time Frame: 5 years
|
Report of a diagnosis of dry eye disease confirmed by medical record review.
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Lacrimal Apparatus Diseases
- Keratoconjunctivitis
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Eye Diseases
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
Other Study ID Numbers
- 2012P001332
- R01EY022663 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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