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）：干眼症（DED）是老年人的重要且普遍的公共卫生问题，每年与近40亿美元的直接和550亿美元的间接费用有关。 Vital-Ded提议研究补充海洋omega-3脂肪酸（FA）对预防DED的功效，以及其相关的慢性眼表面疼痛和生活质量的长期改善，包括阅读和驾驶问题。该研究将利用维生素D和Omega-3试验（Vital，1U01CA138962）的宝贵资源和数据，这是一项随机，双盲，安慰剂对照，2x2 fortorial试验，用于测试海洋omega-3 fa（465 mg/deicososapentaeciac + 375 mg/docosahen cipation Marine Omega-3 fa）（Cholecalciferol，2000 IU/D）分别在20,000名> 50 Y＆> 55 y的男性和女性中预防癌症和心血管疾病的补充剂。从2011年7月开始，在整个2012年继续进行，邀请邮寄的愿意且有资格的受访者将被纳入一个月的磨合，随后在磨合期间保持愿意，符合条件和符合要求的人将被随机分配给Omega-3 FA或匹配的安慰剂和Vitamin D3或Vitamin D3或匹配的位置。在1年的间隔中，参与者将获得新的药丸供应和关注提高有关健康终点的合规性，副作用和发病率的问卷。我们建议确定重要步道中的普遍（随机化）和入射（随机后）DED终点。生命力的主要目的是测试omega-3 FA是否补充：1）降低DED的发生率，2）通过缓解症状和其他对生活质量的影响来改善DED的自然历史。次要目的将估计美国DED的发病率，前瞻性地检查DED的自然历史，探索可以修改或影响欧米茄3 FA补充的影响，评估DED和抑郁症的关系的影响，并测试DED的入射和自然史的维生素D3补充维生素D3的可能独立或关节作用。这项研究旨在响应国家眼科研究所的战略计划的优先事项，以提高我们对炎症性角膜和眼表面疾病的预防策略；还解决了最近关于眼部疼痛和敏感性的NEI NEI研讨会上发现的几个问题。从我们先前的流行病学研究以及实验室研究和小型随机试验中的引人入胜的生物学原理和强大的初步数据支持了这些假设，这表明补充欧米茄-3 FA可以防止DED并改善其自然历史。我们认为，及时的生命开始提供了一个独特但时间敏感的机会，以获得对DED最有前途的预防剂的功效的可靠，高效且信息丰富的评估。鉴于我们在先前的大型简单试验中取得了成功，我们在DED方面的经验以及我们提出的方法学，我们认为Vital-Ded将提供明确的结果，以指导公共卫生和DED预防和管理的临床建议。