Effects of Vitamin D and Omega-3 Supplementation on Telomeres in VITAL
试验速览
- 阶段
- 3 期
- 入组人数
- 1,054
- 试验地点
- 1
- 主要终点
- Changes in telomere length
研究概览
简要总结
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) was a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) 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-CTSC cohort and will examine whether vitamin D or fish oil supplementation has beneficial effects on cellular aging.
详细描述
This project is an ancillary study based on the parental study "the VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259)" at the Harvard Clinical and Translational Science Centre (CTSC) and Brigham and Women's Hospital. Our research focuses on the separate and synergistic effects of vitamin D and omega -3 supplements on telomere length, a cellular aging marker, using de-identified samples from VITAL-CTSC cohort.
Aims: 1) To test the hypothesis that vitamin D supplementation decreases leukocyte telomere length attrition. The investigators will determine the effect of vitamin D supplementation on telomere length attrition over time (Baseline, Year 2, and Year 4); 2) To test the hypothesis that marine omega-3 fatty acid supplementation decreases LTL attrition. The investigators will determine the effect of marine omega-3 fatty acid supplementation on telomere length attrition over time (Baseline, Year 2, and Year 4); 3) To determine to what extent the effects of vitamin D or omega-3 supplementation on inflammatory cytokines and CVD risk factors are mediated by telomere length attrition over time; 4) To explore the synergistic effects vitamin D and omega-3 fatty acid supplementation.
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
- •The subcohort of 1,054 participants in VITAL (NCT 01169259) who are receiving detailed health assessments at a Clinical and Translation Science Center at Boston 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
Dietary supplement: Vitamin D3 (cholecalciferol), 2000 IU per day. Drug: Omega-3 fatty acids (fish oil), Omacor, 1 capsule per day. Each capsule contains 840 mg 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 (cholecalciferol) (Dietary Supplement)
Vitamin D + fish oil
Dietary supplement: Vitamin D3 (cholecalciferol), 2000 IU per day. Drug: Omega-3 fatty acids (fish oil), Omacor, 1 capsule per day. Each capsule contains 840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA).
干预措施: fish oil (Drug)
Vitamin D + fish oil placebo
Dietary supplement: Vitamin D3 (cholecalciferol), 2000 IU per day. Dietary supplement: Fish oil placebo
干预措施: Vitamin D3 (cholecalciferol) (Dietary Supplement)
Vitamin D placebo + fish oil
Drug: Omega-3 fatty acids (fish oil), Omacor, 1 capsule per day. Dietary supplement: Vitamin D3 placebo
干预措施: fish oil (Drug)
Vitamin D placebo + fish oil placebo
Dietary supplement: Vitamin D3 placebo Dietary supplement: Fish oil placebo
干预措施: Vitamin D3 (cholecalciferol) (Dietary Supplement)
Vitamin D placebo + fish oil placebo
Dietary supplement: Vitamin D3 placebo Dietary supplement: Fish oil placebo
干预措施: fish oil (Drug)
结局指标
主要结局
Changes in telomere length
时间窗: 4 years
Leukocyte telomere length (LTL) will be measured using quantitative polymerase chain reaction method at the baseline, year 2 and year 4. we will examine the effect of randomization to vitamin D (primary Aim 1 and or fish oil (primary Aim 2) compared o placebo is different over time on changes in telomere length.
次要结局
- Changes in Inflammation markers(4 years)
研究者
Yanbin Dong
Regents Professor
Augusta University