Omega-3 Fatty Acids for Prevention of Dry Eye Disease: VITAL-DED

用于预防干眼病的 Omega-3 脂肪酸：VITAL-DED

基本信息

批准号：
9128635
负责人：
WILLIAM G CHRISTEN
金额：
$ 42.18万
依托单位：
BRIGHAM AND WOMEN'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-01-01 至 2018-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9128635
关键词：
Address Adrenergic beta-Antagonists Adverse effects Affect Age American Antidepressive Agents Antihistamines Automobile Driving Awareness Biological Cardiovascular Diseases Caring Cholecalciferol Chronic Clinical Comorbidity Cornea Data Diabetes Mellitus Dietary intake Direct Costs Disease Docosahexaenoic Acids Double-Blind Method Educational workshop Eicosapentaenoic Acid Enrollment Epidemiologic Studies Eye Eye diseases Facilities and Administrative Costs Goals Health Health Benefit Healthcare Systems Hypertension Incidence Infection Inflammatory Investigation Joints Laboratories Marines Medical Mental Depression Methodology National Eye Institute Natural History Omacor Omega-3 Fatty Acids Pain quality Participant Patient Education Patients Performance Pharmaceutical Preparations Physicians Placebo Control Placebos Population Prevention Prevention strategy Prevention therapy Preventive Primary Cancer Prevention Primary Prevention Productivity Prospective Studies Public Health Quality of life Questionnaires Race Randomized Randomized Clinical Trials Reading Recommendation Research Resources Respondent Rheumatoid Arthritis Risk Risk Factors Running Secondary Prevention Strategic Planning Supplementation Symptoms Testing Thinking Time Translating United States National Institutes of Health Vitamin D Vitamin D supplementation Woman Women&apos s Health Work aged capsule cost effective disease natural history disorder prevention disorder risk efficacy evaluation efficacy testing experience eye dryness fatty acid supplementation follow-up improved innovation men ocular pain ocular surface older men older women pill prevent programs randomized trial recurrent depression reduce symptoms sex success

项目摘要

DESCRIPTION (provided by applicant): Dry eye disease (DED) is an important and prevalent public health concern for older Americans that is associated with nearly $4 billion in direct and $55 billion in indirect costs annually. VITAL-DED proposes to study the efficacy of marine omega-3 fatty acid (FA) supplementation for the prevention of DED, as well as the long-term amelioration of its associated chronic ocular surface pain and quality of life impacts, which include problems reading and driving. The study will leverage invaluable resources and data from the VITamin D and OmegA-3 TriaL (VITAL, 1U01CA138962), a randomized, double-blind, placebo-controlled, 2x2 factorial trial to test marine omega-3 FA (465 mg/d eicosapentaenoic acid + 375 mg/d docosahexaenoic acid) and vitamin D3 (cholecalciferol, 2000 IU/d) supplements in the primary prevention of cancer and cardiovascular disease among 20,000 men and women aged >50 y & >55 y, respectively. Beginning in July 2011 and continuing throughout 2012, willing and eligible respondents to an invitational mailing will be enrolled in a month run-in, and subsequently those who remain willing, eligible, and compliant during the run-in will be randomly assigned to omega-3 FA or a matching placebo and vitamin D3 or a matching placebo. At 1-year intervals, participants will receive a new supply of pills and a follow up questionnaire on compliance, side effects, and incidence of health endpoints. We propose to ascertain prevalent (pre-randomization) and incident (post-randomization) DED endpoints in the VITAL trail. The primary Specific Aims of VITAL-DED are to test whether omega-3 FA supplementation: 1) reduces the incidence of DED, 2) improves the natural history of DED by relieving symptoms and other impacts on quality of life. Secondary Aims will estimate the incidence of DED in the US, prospectively examine the natural history of DED, explore factors that could modify or influence the impact of omega-3 FA supplementation, evaluate the inter-relationship of DED and depression, and test for possible independent or joint effects of vitamin D3 supplementation in the incidence and natural history of DED. This research is responsive to a program priority of the National Eye Institute's Strategic Plan to improve our understanding of and develop preventive strategies for inflammatory corneal and ocular surface diseases; and also addresses several issues identified in the recent 2010 NEI Workshop on Ocular Pain and Sensitivity. The hypotheses are supported by a compelling biological rationale and strong preliminary data from our prior epidemiological studies, as well as from laboratory investigations and small randomized trials, which suggest that omega-3 FA supplementation, could prevent DED and improve its natural history. We believe the timely start of VITAL-DED offers a unique but time-sensitive opportunity to obtain a reliable, efficient, and informative evaluation of the efficacy of the most promising preventive agent for DED. Given our success with prior large simple trials, our experience with DED, and our proposed methodology, we think VITAL-DED will provide definitive results to guide public health and clinical recommendations for DED prevention and management.

描述（由申请人提供）：干眼病 (DED) 是美国老年人的一个重要而普遍的公共卫生问题，每年造成近 40 亿美元的直接费用和 550 亿美元的间接费用。 VITAL-DED 提议研究补充海洋 omega-3 脂肪酸 (FA) 预防 DED 的功效，以及长期改善其相关的慢性眼表疼痛和生活质量影响，其中包括阅读问题和驾驶。该研究将利用维生素 D 和 OmegA-3 TriaL（VITAL，1U01CA138962）的宝贵资源和数据，这是一项随机、双盲、安慰剂对照、2x2 析因试验，用于测试海洋 omega-3 FA（465 mg/d 二十碳五烯酸）酸 + 375 毫克/天二十二碳六烯酸）和维生素 D3（胆钙化醇， 2000 IU/天）补充剂，分别对 20,000 名年龄 >50 岁和 >55 岁的男性和女性进行癌症和心血管疾病的一级预防。从 2011 年 7 月开始并持续到 2012 年，愿意且符合条件的邀请函受访者将参加为期一个月的磨合，随后那些在磨合期间仍然愿意、符合资格且合规的人将被随机分配到 omega- 3 FA 或匹配的安慰剂和维生素 D3 或匹配的安慰剂。每隔一年，参与者将收到新的药丸和后续药物关于依从性、副作用和健康终点发生率的调查问卷。我们建议确定 VITAL 轨迹中普遍（随机化前）和事件（随机化后）DED 端点。 VITAL-DED 的主要具体目标是测试补充 omega-3 FA 是否能够：1) 降低 DED 的发病率，2) 通过缓解症状和对生活质量的其他影响来改善 DED 的自然史。次要目标将估计美国 DED 的发病率，前瞻性研究 DED 的自然史，探索可能改变或影响 omega-3 FA 补充剂效果的因素，评估 DED 与抑郁症的相互关系，并测试可能的影响因素。补充维生素 D3 对 DED 发生率和自然史的独立或联合影响。这项研究响应国家眼科研究所战略计划的优先项目，以提高我们对炎症性角膜和眼表疾病的了解并制定预防策略；还解决了最近在 2010 年 NEI 眼部疼痛和敏感性研讨会上发现的几个问题。这些假设得到了令人信服的生物学原理和来自我们之前的流行病学研究以及实验室调查和小型随机试验的强有力的初步数据的支持，这些数据表明补充 omega-3 FA 可以预防 DED 并改善其自然史。我们相信，VITAL-DED 的及时启动提供了一个独特但时间敏感的机会，可以对最有前途的 DED 预防药物的功效进行可靠、高效和信息丰富的评估。鉴于我们之前大型简单试验的成功、我们在 DED 方面的经验以及我们提出的方法，我们认为 VITAL-DED 将提供明确的结果来指导 DED 预防和管理的公共卫生和临床建议。