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

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ClinicalTrials.gov Identifier: NCT01880463
Recruitment Status : Active, not recruiting
First Posted : June 19, 2013
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Debra Ann Schaumberg, ScD, OD, MPH, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: Omega-3 fatty acids (fish oil) Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 placebo Drug: Fish oil placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25875 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)
Study Start Date : July 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Dry Eye Disease [ Time Frame: 5 years ]
    Report of a diagnosis of dry eye disease confirmed by medical record review.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Additional Information:
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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 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Keywords provided by Debra Ann Schaumberg, ScD, OD, MPH, Brigham and Women's Hospital:
Dry eye disease
incidence
progression
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents