The VITamin D and OmegA-3 TriaL (VITAL)

维生素 D 和 OmegA-3 试用版 (VITAL)

• 批准号: 8758917
• 负责人: Julie E. Buring
• 金额: $ 433.52万
• 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 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8758917
• 关键词: 25-hydroxyvitamin D; Adult; Adverse effects; Age; Ancillary Study; Archives; Attention; Autoimmune Diseases; Benefits and Risks; Biochemical; Biological Assay; Biological Markers; Blinded; Blood; Blood Vessels; Blood specimen; Body mass index; Cardiovascular Diseases; Cessation of life; Charge; Cholecalciferol; Chronic Disease; Clinic; Clinical; Clinical Trials; Collaborations; Collection; Colorectal Cancer; Contracts; Controlled Clinical Trials; Coronary; Coronary Artery Bypass; DNA; Data; Diabetes Mellitus; Disease; Docosahexaenoic Acids; Dose; Double-Blind Method; Eicosapentaenoic Acid; Enrollment; Equilibrium; Ethnic Origin; Etiology; Event; Exhibits; Fish Oils; Funding; General Population; Genetic screening method; Goals; Health; Health Benefit; Impaired cognition; Individual; Institute of Medicine (U.S.); Knowledge; Laboratories; Literature; Maintenance; Malignant Neoplasms; Malignant neoplasm of prostate; Marines; Measurement; Medical; Medical Records; Mental Depression; Modification; Myocardial Infarction; Nutritional; Omacor; Omega-3 Fatty Acids; Outcome; Participant; Patient Self-Report; Persons; Phenotype; Physicians; Placebo Control; Placebos; Population; Primary Cancer Prevention; Primary Prevention; Public Health; Publishing; Questionnaires; Race; Randomized; Recommendation; Recommended Dietary Allowance; Reporting; Research; Resources; Risk; Risk Factors; Role; Running; Sampling; Source; Specific qualifier value; Stroke; Supplementation; Testing; Time; Venous blood sampling; Vitamin D; Woman; adjudication; aged; base; biobank; bone; cancer risk; capsule; cardiovascular disorder risk; cardiovascular risk factor; cohort; compliance behavior; cost; cost efficient; design; follow-up; indexing; industry partner; innovation; malignant breast neoplasm; meetings; men; mortality; nutrient blood level; percutaneous coronary intervention; prevent; public health relevance; randomized trial; treatment duration; validation studies

DESCRIPTION (provided by applicant): This is a renewal application for a 5-year continuation of the VITamin D and OmegA-3 TriaL (VITAL), which is evaluating the role of vitamin D and marine omega-3 fatty acid supplements in the primary prevention of cancer and cardiovascular disease (CVD). Evidence for a role of these agents in preventing cancer, CVD, and other diseases remains inconclusive regarding causality and insufficient to inform nutritional recommendations for primary prevention. Appropriately designed randomized trials in general populations are lacking. To fill this knowledge gap, we have been conducting VITAL, a highly innovative, cost-efficient, large-scale, randomized, double-blind, placebo-controlled clinical tria among 26,000 U.S. men and women without cancer or CVD at baseline, who have been selected only on age (men aged e50 and women aged e55), with an oversampling of blacks (ne5000). In a 2x2 factorial design, participants have been randomized to vitamin D3 (cholecalciferol, 2000 IU/d) and marine omega-3 fatty acids (Omacor(R) fish oil, 1 g/d, containing eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA]) supplements (or placebos) independently. Contingent on continued funding, the median treatment period will be 5 years. During the first cycle, we have successfully met or surpassed our recruitment goals, enrolled a racially/ethnically diverse cohort, collected baseline blood/DNA samples on >16,000 participants (with plans for follow-up bloods in 6000), and conducted extensive validation studies of the laboratory assays for vitamin D and omega-3 fatty acid measurements in the trial. Annual follow-up questionnaires assess treatment compliance (confirmed by blood samples in a subset of participants), side effects, endpoint occurrence, and cancer and vascular risk factors. Self-reported endpoints are confirmed by medical record review by physicians blinded to treatment assignment, and deaths are ascertained through the National Death Index-Plus and other sources. Our archived blood samples allow assessment of effect modification by baseline 25-hydroxyvitamin D and omega-3 fatty acid levels, changes in biomarkers over time, and testing of genetic/biochemical hypotheses. With our scientific colleagues, we have obtained funding for 18 ancillary studies to evaluate the role of these supplements in preventing other chronic diseases (including diabetes, cognitive decline, depression, and autoimmune disorders), and established an in-clinic component for in-depth phenotyping of a subcohort (n=1000). The trial is expected to provide either definitive positive or informative null results for our primary hypotheses and will serve as a national resource for research on the health effects of vitamin D and omega-3 fatty acids, with opportunities for extensive collaborations. This is a high-impact trial due to the potential for major clinical and public health implications of the findings.

描述（由申请人提供）：这是一份延续 5 年维生素 D 和 OmegA-3 TriaL (VITAL) 的续展申请，该申请正在评估维生素 D 和海洋 omega-3 脂肪酸补充剂在初级保健中的作用。预防癌症和心血管疾病（CVD）。这些药物在预防癌症、心血管疾病和其他疾病方面的作用证据在因果关系方面仍然没有定论，也不足以为一级预防提供营养建议。缺乏针对一般人群的适当设计的随机试验。为了填补这一知识空白，我们一直在开展 VITAL，这是一项高度创新、具有成本效益、大规模、随机、双盲、安慰剂对照的临床试验，研究对象为 26,000 名基线时没有癌症或 CVD 的美国男性和女性，他们仅根据年龄（e50 岁的男性和 e55 岁的女性）进行选择，并对黑人进行过采样 (ne5000)。在 2x2 析因设计中，参与者被随机分配服用维生素 D3（胆钙化醇，2000 IU/天）和海洋 omega-3 脂肪酸（Omacor(R) 鱼油，1 g/天，含有二十碳五烯酸 [EPA] + 二十二碳六烯酸） [DHA]）独立补充剂（或安慰剂）。如果持续资助，中位治疗期将为 5 年。在第一个周期中，我们成功达到或超越了我们的招募目标，招募了种族/民族多样化的队列，收集了超过 16,000 名参与者的基线血液/DNA 样本（计划采集 6000 名后续血液），并进行了广泛的验证研究试验中维生素 D 和 omega-3 脂肪酸测量的实验室测定。年度随访调查问卷评估治疗依从性（通过一部分参与者的血液样本证实）、副作用、终点发生以及癌症和血管危险因素。自我报告的终点由对治疗分配不知情的医生审查病历来确认，死亡情况通过国家死亡指数增强版和其他来源确定。我们存档的血液样本可以通过基线 25-羟基维生素 D 和 omega-3 脂肪酸水平、生物标志物随时间的变化以及遗传/生化假设测试来评估效果修改。我们与我们的科学同事一起，获得了 18 项辅助研究的资助，以评估这些补充剂在预防其他慢性疾病（包括糖尿病、认知能力下降、抑郁症和自身免疫性疾病）方面的作用，并建立了深入研究的临床部分。亚队列的表型分析 (n=1000)。该试验预计将为我们的主要研究提供明确的阳性结果或无效结果 假设，并将作为维生素 D 和 omega-3 脂肪酸对健康影响研究的国家资源，并提供广泛合作的机会。这是一项具有高影响力的试验，因为研究结果可能对临床和公共卫生产生重大影响。