Vitamin D and Omega-3 Trial (VITAL)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 25,871
- 试验地点
- 1
- 主要终点
- Number of Participants With a Major Cardiovascular Event
研究概览
简要总结
The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 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. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.
详细描述
The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial of vitamin D (in the form of vitamin D3 [cholecalciferol]) and marine omega-3 fatty acid (eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA]) supplements in the primary prevention of cancer and cardiovascular disease (CVD). Existing data from laboratory studies, epidemiologic research, small primary prevention trials, and/or large secondary prevention trials strongly suggest that these nutritional agents may reduce risk for cancer or CVD, but large primary prevention trials with adequate dosing in general populations are lacking.
VITAL tested the independent effects of vitamin D and omega-3 fatty acid supplementation on risk for developing cancer and CVD (primary, secondary, and other outcomes are specified in the Outcome Measures section). VITAL also explored (a) whether vitamin D and omega-3 fatty acid supplements exhibit synergistic or additive effects on cancer and CVD risk and (b) whether the effect of each supplement on cancer and CVD risk varies by baseline blood levels or intake of vitamin D and EPA+DHA, race/ethnicity, and body mass index (for vitamin D), as well as age, sex, sunlight exposure, calcium intake, and baseline risk factors for cancer and CVD.
Eligible participants were assigned by chance (like a coin toss) to one of four groups: (1) daily vitamin D and omega-3; (2) daily vitamin D and omega-3 placebo; (3) daily vitamin D placebo and omega-3; or (4) daily vitamin D placebo and omega-3 placebo. Participants had an equal chance of being assigned to any of these four groups and a 3 out of 4 chance of getting at least one active agent.
Participants in all groups took two pills each day -- one softgel that contained either vitamin D or vitamin D placebo and one capsule that contained either omega-3 or omega-3 placebo. Participants received their study pills in convenient calendar packages via U.S. mail.
Participants fill out a short (15-20 minute) questionnaire each year. The questionnaire asks about health; lifestyle habits such as physical exercise, diet, and smoking; use of medications and dietary supplements; family history of illness, and new medical diagnoses. We request consent for medical record review to confirm endpoints. Occasionally, participants may receive a phone call from study staff to collect information or to clarify responses on the questionnaire.
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
- •To be eligible for the study, respondents had to, at study entry,:
- •be men aged 50 or older or women aged 55 or older;
- •have no history of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, coronary-artery bypass grafting, or percutaneous coronary intervention;
- •have none of the following safety exclusions: history of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or granulomatosis with polyangiitis (Wegener's);
- •have no allergy to fish or soy;
- •have no other serious illness that would preclude participation;
- •be consuming no more than 800 IU of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium+vitamin D supplements, medications with vitamin D [e.g., Fosamax Plus D], and multivitamins), or, if taking, willing to decrease or forego such use during the trial;
- •be consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial;
- •not be taking fish oil supplements, or, if taking, willing to forego their use during the trial
排除标准
- 未提供
研究组 & 干预措施
Vitamin D placebo + fish oil placebo
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D + fish oil placebo
干预措施: Fish oil placebo (Dietary Supplement)
Vitamin D placebo + fish oil
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D placebo + fish oil placebo
干预措施: Fish oil placebo (Dietary Supplement)
Vitamin D + fish oil
干预措施: omega-3 fatty acids (fish oil) (Drug)
Vitamin D placebo + fish oil
干预措施: omega-3 fatty acids (fish oil) (Drug)
Vitamin D + fish oil
干预措施: vitamin D3 (Dietary Supplement)
Vitamin D + fish oil placebo
干预措施: vitamin D3 (Dietary Supplement)
结局指标
主要结局
Number of Participants With a Major Cardiovascular Event
时间窗: 5 years
Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes
Number of Participants With Invasive Cancer of Any Type
时间窗: 5 years
Number of participants with invasive cancer of any type
Number of Participants With Invasive Cancer of Any Type
时间窗: 5 years
Number of participants with invasive cancer of any type
Number of Participants With a Major Cardiovascular Event
时间窗: 5 years
Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes
次要结局
- Number of Participants With Myocardial Infarction(5 years)
- Number of Participants Who Died From Cardiovascular Causes(5 years)
- Number of Participants Who Died From Any Cause(5 years)
- Number of Participants With Invasive Cancer of Any Type, Excluding First 2 Years of Follow-up(5 years, excluding first 2 years of follow-up)
- Number of Participants With a Major Cardiovascular Event, Excluding First 2 Years of Follow-up(5 years, excluding first 2 years of follow-up)
- Number of Participants Who Died From Invasive Cancer of Any Type(5 years)
- Number of Female Participants With Breast Cancer(5 years)
- Number of Male Participants With Prostate Cancer(5 years)
- Number of Participants With Colorectal Cancer(5 years)
- Number of Participants With Cardiovascular Event in Expanded Composite Cardiovascular Endpoint(5 years)
- Number of Female Participants With Breast Cancer(5 years)
- Number of Participants Who Died From Invasive Cancer of Any Type(5 years)
- Number of Male Participants With Prostate Cancer(5 years)
- Number of Participants With Colorectal Cancer(5 years)
- Number of Participants With Cardiovascular Event in Expanded Composite Cardiovascular Endpoint(5 years)
- Number of Participants With Myocardial Infarction(5 years)
- Number of Participants With Stroke(5 years)
- Number of Participants Who Died From Cardiovascular Causes(5 years)
- Number of Participants Who Died From Any Cause(5 years)
- Number of Participants With Invasive Cancer of Any Type, Excluding First 2 Years of Follow-up(5 years, excluding first 2 years of follow-up)
- Number of Participants With a Major Cardiovascular Event, Excluding First 2 Years of Follow-up(5 years, excluding first 2 years of follow-up)
研究者
JoAnn E. Manson, MD
Principal Investigator
Brigham and Women's Hospital