Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)
试验速览
- 阶段
- 不适用
- 入组人数
- 25,875
- 主要终点
- Dry Eye Disease
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.
排除标准
- 未提供
研究组 & 干预措施
Vitamin D + fish oil placebo
Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo
干预措施: Vitamin D3 (Dietary Supplement)
Vitamin D + fish oil placebo
Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo
干预措施: Fish oil placebo (Drug)
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])
干预措施: Omega-3 fatty acids (fish oil) (Drug)
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])
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D placebo + fish oil placebo
Vitamin D placebo
fish oil placebo
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D placebo + fish oil placebo
Vitamin D placebo
fish oil placebo
干预措施: Fish oil placebo (Drug)
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])
干预措施: Omega-3 fatty acids (fish oil) (Drug)
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])
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Dry Eye Disease
时间窗: 5 years
Report of a diagnosis of dry eye disease confirmed by medical record review.
次要结局
未报告次要终点
研究者
Debra Ann Schaumberg, ScD, OD, MPH
Associate Professor
Brigham and Women's Hospital