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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Debra Ann Schaumberg, ScD, OD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01880463
First received: June 15, 2013
Last updated: January 17, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention
Dry Eye Disease
Drug: Omega-3 fatty acids (fish oil)
Dietary Supplement: Vitamin D3
Dietary Supplement: Vitamin D3 placebo
Drug: Fish oil placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 25875
Study Start Date: July 2010
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D + fish oil placebo

Vitamin D3 (cholecalciferol), 2000 IU per day

Fish oil placebo

Dietary Supplement: Vitamin D3
Other Name: cholecalciferol
Drug: Fish oil placebo
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])

Drug: Omega-3 fatty acids (fish oil)
Other Name: Omacor
Dietary Supplement: Vitamin D3 placebo
Placebo Comparator: Vitamin D placebo + fish oil placebo

Vitamin D placebo

fish oil placebo

Dietary Supplement: Vitamin D3 placebo Drug: 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])

Drug: Omega-3 fatty acids (fish oil)
Other Name: Omacor
Dietary Supplement: Vitamin D3
Other Name: cholecalciferol

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
Responsible Party: Debra Ann Schaumberg, ScD, OD, MPH, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01880463     History of Changes
Other Study ID Numbers: 2012P001332  R01EY022663 
Study First Received: June 15, 2013
Last Updated: January 17, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Dry eye disease
incidence
progression

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Vitamins
Cholecalciferol
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 26, 2016