VITAL-AMD: Prevention of AMD in the VITamin D and OmegA-3 Trial

VITAL-AMD：维生素 D 和 OmegA-3 试验中预防 AMD

• 批准号: 8534132
• 负责人: WILLIAM G CHRISTEN
• 金额: $ 73.41万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8534132
• 关键词: Address; Adverse effects; Age; Age related macular degeneration; Ancillary Study; Angiogenesis Inhibitors; Anti-Inflammatory Agents; Anti-inflammatory; Antioxidants; Attention; Benefits and Risks; Blindness; Blood specimen; Cardiovascular Diseases; Cholecalciferol; Clinical; Clinical Trials; Clinical Trials Design; Cohort Studies; Complement Factor H; Data; Docosahexaenoic Acids; Double-Blind Method; Eicosapentaenoic Acid; Elderly; Enrollment; Evaluation; Exudative age-related macular degeneration; Fatty Acids; Fish Oils; Funding; Gene-Modified; Genes; Genetic Polymorphism; Guidelines; Health Benefit; Incidence; Literature; Mails; Marines; Medical; Metabolic; Methodology; National Eye Institute; Omega-3 Fatty Acids; Participant; Pathway interactions; Patients; Placebo Control; Placebos; Prevention; Preventive; Primary Cancer Prevention; Primary Prevention; Property; Public Health; Questionnaires; RORA gene; Randomized; Reducing Agents; Reporting; Research; Resources; Respondent; Risk; Role; Running; Sampling; Secondary Prevention; Staging; Strategic Planning; Subgroup; Supplementation; Testing; Time; United States National Institutes of Health; Vascular Endothelial Growth Factors; Visual Acuity; Vitamin D; Vitamin D3 Receptor; Woman; Zinc; advanced disease; aged; base; case control; cohort; cost; cost effective; desaturase; design; efficacy testing; experience; follow-up; geographic atrophy; innovation; men; older men; older women; pill; programs; public health relevance; sex; success

DESCRIPTION (provided by applicant): This application proposes to study the efficacy of vitamin D3 and marine omega-3 fatty acid supplementation for prevention of age-related macular degeneration (AMD), the leading cause of blindness in the US. The study will leverage invaluable resources and data from the VITamin D and OmegA-3 TriaL (VITAL), a randomized, double-blind, placebo-controlled, 2x2 factorial trial designed to test vitamin D (vitamin D3 [cholecalciferol], 2000 IU/d) and marine omega-3 fatty acid (eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA], 1 g/d) supplements in the primary prevention of cancer and cardiovascular disease. The National Institutes of Health (1U01CA138962) is funding the main VITAL trial, which will study 20,000 men aged e60 y and women aged $ e65 y. Beginning in October 2010 and continuing throughout 2011, willing and eligible respondents to an $ invitational mailing will be enrolled in a 3-month run-in, and subsequently those who remain willing and eligible, and who report having taken at least two-thirds of study pills, will be randomly assigned to 1 of 4 treatment groups for 5 years: vitamin D3 (2000 IU/d) and fish oil (EPA+DHA, 1 g/d); vitamin D3 and fish oil placebo; vitamin D3 placebo and fish oil; and vitamin D3 placebo and fish oil placebo. 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. We propose to ascertain prevalent and incident AMD endpoints in the VITAL cohort in order to study the efficacy of vitamin D3 and fish oil in AMD prevention. The Primary Aims of this ancillary study are to test whether: 1) fish oil supplementation (EPA+DHA, 1g/d) reduces the incidence and progression of AMD and whether 2) vitamin D3 supplementation (2000 IU/d) reduces the incidence and progression of AMD. Secondary Aims will test for synergistic or antagonistic effects of vitamin D3 and fish oil, as well as interactions of vitamin D3 and fish oil with common AMD-associated genetic polymorphisms, and polymorphisms related to pathways involved in vitamin D3 or omega-3 fatty acid metabolic activity. This research is responsive to a program priority of the National Eye Institute's Strategic Plan to develop new treatments for AMD. We believe the timely start of the proposed AMD ancillary to the VITAL trial offers a unique but time-sensitive opportunity to obtain a reliable, efficient, and informative evaluation o the efficacy of two extremely promising preventive agents for AMD at a fraction of the cost of separate trials. Given our success with prior mail-based, large, simple trials and cohort studies, our experience with AMD, and our proposed methodology, we believe the trial will be able to provide either definitive positive or informative null results regarding the study hypotheses.

描述（由申请人提供）：本申请建议研究维生素D3和海洋omega-3脂肪酸补充剂预防与年龄相关的黄斑变性（AMD）的功效，这是美国失明的主要原因。该研究将利用维生素D和Omega-3试验（Vital）的宝贵资源和数据，这是一项随机，双盲，安慰剂对照的2x2阶乘试验，旨在测试维生素D（维生素D3 [胆固醇酚]，2000 IU// IU// IU/// D）和海洋omega-3脂肪酸（Eicosapentaenoic [EPA] + docosahecahexaenoic [DHA]，1 g/d）补充了癌症和心血管疾病的主要预防。美国国立卫生研究院（1U01CA138962）正在为主要重要试验提供资金，该试验将研究20,000名E60岁的男性和E65 $ $ E65岁的妇女。从2010年10月开始，在整个2011年继续，有资格且符合条件的受访者将参加$邀请邮件的邮寄，并将参加3个月的磨合，随后那些保持愿意和符合条件的人，并报告了至少三分之二的人研究丸，将随机分配给4个治疗组中的1个：维生素D3（2000 IU/d）和鱼油（EPA+DHA，1 g/d）；维生素D3和鱼油安慰剂；维生素D3安慰剂和鱼油；和维生素D3安慰剂和鱼油安慰剂。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。我们建议确定重要队列中的流行和事件AMD端点，以研究维生素D3和鱼油预防中维生素D3和鱼油的功效。这项辅助研究的主要目的是测试是否：1）补充鱼油（EPA+DHA，1G/d）会降低AMD的发生率和进展，以及2）补充维生素D3（2000 IU/D）会降低发病率和发病率和AMD的进展。次要目的将测试维生素D3和鱼油的协同或拮抗作用，以及维生素D3和鱼油的相互作用 具有常见的AMD相关遗传多态性，以及与涉及维生素D3或Omega-3脂肪酸代谢活性的途径相关的多态性。这项研究对国家眼睛研究所的战略计划的计划优先措施响应，以开发AMD的新治疗方法。我们认为，重要试验拟议的AMD辅助的及时开始提供了一个独特但时间敏感的机会，以获得可靠，高效且信息丰富的评估o o两位极有前途的预防剂对AMD的有效性，以一小部分成本的成本单独的试验。鉴于我们在先前基于邮件的，大型的，简单的试验和队列研究，对AMD的经验以及我们提出的方法学方面的成功，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。