COSMOS Eye: Cataract and AMD in a Trial of a Multivitamin and Cocoa Extract

COSMOS Eye：多种维生素和可可提取物试验中的白内障和 AMD

• 批准号: 9353400
• 负责人: WILLIAM G CHRISTEN
• 金额: $ 47.89万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-30 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9353400
• 关键词: Adult; Adverse effects; Age related macular degeneration; American; Ancillary Study; Antioxidants; Benefits and Risks; Cardiovascular Diseases; Cataract; Cataract Extraction; Clinical; Clinical Trials; Cocoa Powder; Cohort Studies; Data; Diagnosis; Dietary intake; Dose; Double-Blind Method; Elderly; Eligibility Determination; Endothelium; Enrollment; Equilibrium; Event; Exhibits; Exudative age-related macular degeneration; Eye; Eye diseases; Flavanol; Formulation; Grant; Health; Incidence; Individual; Inflammation; Leadership; Legal patent; Link; Lipids; Lutein; Malignant Neoplasms; Multivitamin; National Eye Institute; National Heart, Lung, and Blood Institute; Nutritional status; Omega-3 Fatty Acids; Outcome Study; Parents; Participant; Persons; Physicians; Placebo Control; Planet Mars; Population; Prevention; Preventive; Process; Questionnaires; Randomized; Randomized Controlled Trials; Research; Research Infrastructure; Resources; Respondent; Risk; Risk Factors; Role; Running; Silver; Strategic Planning; Supplementation; Target Populations; Testing; Theobromine; Vascular System; Vasodilation; Visual Acuity; Visual impairment; Vitamin D; Woman; Women' s Health; aged; base; capsule; cardiovascular disorder prevention; cardiovascular disorder risk; choroidal circulation; cohort; cost; cost effective; design; dietary supplements; efficacy evaluation; efficacy study; epicatechin; follow-up; geographic atrophy; improved; innovation; male; men; pill; polyphenol; programs; randomized trial; treatment group; zeaxanthin

This revised application proposes to study the efficacy of a multivitamin and cocoa extract supplementation in prevention of cataract and age-related macular degeneration (AMD), two leading causes of visual impairment in US adults. Recent findings from the Physicians’ Health Study II, the only large-scale clinical trial of a daily multivitamin, indicated a significant reduction in cataract, but an elevated, though statistically non-significant, increased risk of AMD. These findings in men require confirmation in other men and extension to women. The proposed study will utilize resources and data from the COcoa-Supplement and Multivitamins Outcomes Study (COSMOS), a randomized, double-blind, placebo-controlled, 2x2 factorial trial testing a patented, high-quality cocoa extract supplement (Mars Symbioscience) and Centrum Silver multivitamin (Pfizer) in the prevention of cardiovascular disease and cancer among 12,000 women aged ≥65 years and 6,000 men aged ≥60 years with 4 years of treatment and follow-up. Woman participants will be drawn from the Women’s Health Initiative (WHI) cohort, and male participants will be drawn from a target population screened for participation (but not randomized) in the VITamin D and OmegA-3 TriaL (VITAL). Beginning in June, 2015 and continuing through 2016, willing and eligible respondents to an invitational mailing will be enrolled in a 3-month run-in. Those who demonstrate good compliance with pill taking during the run-in, and remain willing and eligible, will be randomly assigned to 1 of 4 treatment groups for 5 years. 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 document incident cataract and prevalent and incident AMD endpoints in the COSMOS cohort in order to evaluate the efficacy of multivitamin and cocoa extract supplements in cataract and AMD prevention. The primary aims of the proposed study are to test whether 1) a daily multivitamin will reduce the risk of cataract; 2) a daily multivitamin will reduce the risk of total AMD events, a composite of incident AMD plus cases of progression to advanced AMD (neovascular AMD plus central geographic atrophy) among participants with prevalent AMD at baseline. The effect of cocoa extract supplements (capsule containing 750 mg/d flavanols, including 75 mg (-)-epicatechin, and 90 mg theobromine) in reducing risks of AMD and cataract will be examined as secondary aims. This research is responsive to a program priority of the National Eye Institute’s Strategic Plan to improve diagnosis, treatment, and prevention of eye disease. We believe the proposed eye disease ancillary to COSMOS offers a unique opportunity to obtain a reliable, efficient, and informative evaluation of the efficacy of two extremely promising preventive agents for cataract and AMD at a fraction of the cost of separate trials.

该修订后的申请旨在研究复合维生素和可可提取物补充剂的功效 预防白内障和年龄相关性黄斑变性 (AMD)，这是视力障碍的两个主要原因 医生健康研究 II 的最新发现是唯一一项每日进行的大规模临床试验。 多种维生素，表明白内障显着减少，但虽然技术上不显着，但白内障的发生率有所升高。 男性患 AMD 的风险增加。这些发现需要在其他男性中得到证实，并扩展到女性。 拟议的研究将利用可可补充剂和多种维生素结果研究的资源和数据 (COSMOS)，一项随机、双盲、安慰剂对照、2x2 析因试验，测试一项获得专利的高质量 可可提取物补充剂（Mars Symbioscience）和 Centrum Silver 多种维生素（辉瑞）预防 12,000 名年龄 ≥ 65 岁的女性和 6,000 名年龄 ≥ 60 岁的男性的心血管疾病和癌症 女性参与者将从女性健康倡议 (WHI) 中抽取，进行为期 4 年的治疗和随访。 队列，男性将从筛选参与的目标人群中抽取（但不包括 从 2015 年 6 月开始，一直持续到维生素 D 和 OmegA-3 TriaL (VITAL) 中。 2016 年，愿意且符合资格的邀请函受访者将参加为期 3 个月的磨合期。 在磨合期间表现出良好的服药依从性，并保持意愿和资格，将随机 被分配到 4 个治疗组中的 1 个治疗组，为期 5 年，每隔 1 年，参与者将获得新的供应。 药物和关于依从性、可能的副作用和终点发生率的后续调查问卷。 建议记录 COSMOS 队列中白内障事件以及流行和事件 AMD 终点 为了评估多种维生素和可可提取物补充剂在白内障和 AMD 预防方面的功效。 拟议研究的主要目的是测试 1) 每日服用多种维生素是否会降低患以下疾病的风险： 2) 每日服用多种维生素将降低总 AMD 事件的风险，即 AMD 事件加上 进展为晚期 AMD（新生血管性 AMD 加上中央地理性萎缩）的病例 基线时患有 AMD 的参与者可可提取物补充剂（胶囊含 750 粒）的效果。 mg/d 黄烷醇，包括 75 mg (-)-表儿茶素和 90 mg 可可碱）可降低 AMD 和白内障的风险 该研究将作为次要目标进行审查，以响应国家之眼的计划优先事项。 研究所旨在改善眼部疾病诊断、治疗和预防的战略计划。 与 COSMOS 相关的眼部疾病治疗提供了一个独特的机会来获得可靠、高效和 对两种极具前景的白内障和 AMD 预防药物的功效进行了信息评估 单独试验成本的一小部分。