VITamin D and omegA-3 triaL (VITAL)

维生素 D 和 omega-3 试用版 (VITAL)

• 批准号: 8724141
• 负责人: Julie E. Buring
• 金额: $ 15.42万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-29 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8724141
• 关键词: 25-hydroxyvitamin D; Address; Adverse effects; African American; Age; American; Ancillary Study; Antioxidants; Attention; Benefits and Risks; Biochemical; Biological Availability; Blood Vessels; Blood specimen; Body mass index; Boxing; Cardiovascular Diseases; Cardiovascular system; Cholecalciferol; Clinical Trials; Cohort Studies; Colorectal Cancer; Consent Forms; Controlled Clinical Trials; Coronary; Coronary Artery Bypass; Data; Diabetes Mellitus; Diet; Dietary Intervention; Dietary intake; Direct Costs; Docosahexaenoic Acids; Dose; Double-Blind Method; Educational workshop; Eicosapentaenoic Acid; Enrollment; Epidemiologic Studies; Event; Exhibits; Fatty acid glycerol esters; Fish Oils; Food; Food Supply; Funding; Future; General Population; Genetic; Health; Health Benefit; Health Professional; Incidence; Individual; Institutes; Judgment; Knowledge; Laboratory Study; Letters; Literature; Magic; Mails; Malignant Neoplasms; Malignant neoplasm of prostate; Marines; Medical; Medical History; Medical Records; Methodology; Modification; Myocardial Infarction; National Cancer Institute; National Heart, Lung, and Blood Institute; National Institute of Neurological Disorders and Stroke; Nutritional; Obesity; Observational Study; Omega-3 Fatty Acids; Participant; Personal Communication; Persons; Pharmaceutical Preparations; Pigments; Pilot Projects; Placebo Control; Placebos; Population; Prevalence; Primary Cancer Prevention; Primary Prevention; Public Health; Questionnaires; Race; Randomized; Randomized Clinical Trials; Recruitment Activity; Reducing Agents; Reporting; Respondent; Risk; Risk Factors; Role; Running; Sales; Secondary Prevention; Skin; Skin Pigmentation; Societies; Solar Energy; Source; Specific qualifier value; Stroke; Supplementation; Testing; United States National Institutes of Health; Vitamin D; Vitamin E; Woman; aged; aging population; base; bone health; cancer prevention; cancer risk; cardiovascular disorder prevention; cardiovascular disorder risk; cardiovascular risk factor; cost effective; design; dietary supplements; disorder risk; follow-up; fortification; high risk; malignant breast neoplasm; member; men; middle age; mortality; nutrient blood level; older women; percutaneous coronary intervention; pill; protective effect; randomized trial; response; retiree; success

DESCRIPTION (provided by applicant): We propose to conduct a large, cost-effective, randomized, double-blind, placebo-controlled, 2x2 factorial 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). Data from laboratory studies, epidemiologic research, small primary prevention trials, and/or large secondary prevention trials strongly suggest that these nutritional agents reduce cancer or CVD risk, but large primary prevention trials with adequate dosing in general populations (i.e., unselected for disease risk) are lacking. Growing enthusiasm for supplemental vitamin D and fish oil underscores the urgent need for a timely initiation of such a trial, before their use becomes so prevalent (through supplements and fortification of the food supply) as to render participant recruitment and hypothesis testing impossible. The proposed trial will be conducted among 20,000 men aged e60 and women aged e65, to be recruited from a mailing to 1.2 million persons, including health and other professionals, members of AARP (formerly known as the American Association of Retired Persons), and others. The mailing will contain a letter describing the trial, an informed consent form, and a questionnaire soliciting information on past medical history, cancer and vascular risk factors, diet, and medication and nutritional supplement use. Willing and eligible respondents will be enrolled in a 3-month run-in, during which they will receive placebos. At the end of the run-in, those who remain willing and eligible, and who report having taken at least two-thirds of the pills, will be randomly assigned to one of four treatment groups for 5 years: vitamin D3 (1600 IU/d) and fish oil (EPA+DHA, 1 g/d); vitamin D3 and fish oil placebo; placebo vitamin D3 and fish oil; and placebo vitamin D3 and placebo fish oil. Blood samples will be collected and stored to allow assessment of effect modification by baseline 25-hydroxyvitamin D and omega-3 fatty acid levels, as well as future ancillary studies of genetic/biochemical hypotheses. At 1-year intervals, participants will receive a new supply of pills and a follow-up questionnaire on compliance, possible side effects, and incidence of endpoints. Endpoints will be confirmed by medical record review. Given our success with prior mail-based large simple trials and cohort studies, as well as results of a pilot study in the intended source population, we believe the trial will be able to provide either definitive positive or informative null results regarding the study hypotheses.

DESCRIPTION (provided by applicant): We propose to conduct a large, cost-effective, randomized, double-blind, placebo-controlled, 2x2 factorial 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和心血管疾病（CVD）。实验室研究，流行病学研究，小型预防试验和/或大型二级预防试验的数据强烈表明，这些营养剂降低了癌症或CVD风险，但是缺乏大量的初级预防试验，但缺乏一般人群中的适当剂量（即未选择的疾病风险）。对补充维生素D和鱼油的热情越来越强调，迫切需要及时开始这种试验，然后它们的使用变得如此普遍（通过补充剂和粮食供应的补充），以使参与者招募和假设测试不可能。拟议的审判将在20,000名E60岁的男性和年龄E65岁的妇女中进行，将从邮寄到120万人，包括健康和其他专业人员，AARP（以前称为美国退休人员协会）等人。邮寄将包含一封描述试验的信，知情同意书以及一份问卷，以征求有关过去病史，癌症和血管危险因素，饮食以及药物和营养补充剂的信息。愿意且符合条件的受访者将入学3个月的磨合，在此期间他们将接受安慰剂。在磨合结束时，那些愿意和符合条件的人，报告至少三分之二的药丸的人将被随机分配给四个治疗组之一：维生素D3（1600 IU/d）和鱼油（EPA+DHA，1 g/d）；维生素D3和鱼油安慰剂；安慰剂维生素D3和鱼油；和安慰剂维生素D3和安慰剂鱼油。将收集并存储血液样本，以评估基线25-羟基维生素D和Omega-3脂肪酸水平的效果修饰，以及对遗传/生化假设的未来辅助研究。在1年的间隔内，参与者将获得新的药丸供应，以及有关遵守，可能的副作用和终点发病率的后续调查表。终点将通过病历审查确认。鉴于我们通过基于邮件的大型简单试验和队列研究的成功，以及预期源人群中的试点研究的结果，我们认为该试验将能够就研究假设提供确定的积极或信息性的无效结果。