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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Debra Schaumberg, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01880463
First received: June 15, 2013
Last updated: May 29, 2014
Last verified: May 2014

June 15, 2013
May 29, 2014
July 2010
October 2017   (final data collection date for primary outcome measure)
Dry Eye Disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Report of a diagnosis of dry eye disease confirmed by medical record review.
Same as current
Complete list of historical versions of study NCT01880463 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)
Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Dry Eye Disease
  • Drug: Omega-3 fatty acids (fish oil)
    Other Name: Omacor
  • Dietary Supplement: Vitamin D3
    Other Name: cholecalciferol
  • Active Comparator: Vitamin D + fish oil placebo
    Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo
    Intervention: Dietary Supplement: Vitamin D3
  • 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])
    Intervention: Drug: Omega-3 fatty acids (fish oil)
  • 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])
    Interventions:
    • Drug: Omega-3 fatty acids (fish oil)
    • Dietary Supplement: Vitamin D3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25875
October 2017
October 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01880463
2012P001332, R01EY022663
Yes
Debra Schaumberg, Brigham and Women's Hospital
Brigham and Women's Hospital
National Eye Institute (NEI)
Not Provided
Brigham and Women's Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP