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

• 批准号: 8534136
• 负责人: DEBRA A SCHAUMBERG
• 金额: $ 36.13万
• 依托单位: UNIVERSITY OF UTAH
• 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 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8534136
• 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; Mails; 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; Time; Translating; United States National Institutes of Health; Vitamin D; Woman; Women' s Health; Work; aged; capsule; cost effective; disease natural history; disorder prevention; disorder risk; efficacy evaluation; efficacy testing; experience; eye dryness; follow-up; improved; innovation; men; ocular pain; ocular surface; older men; older women; pill; prevent; programs; public health relevance; randomized trial; recurrent depression; sex; success

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)是美国老年人普遍关注的重要公共卫生问题，每年与近40亿美元的直接成本和550亿美元的间接成本有关。VITAL-DED建议研究补充海洋omega-3脂肪酸(FA)预防DED的有效性，以及长期改善与其相关的慢性眼表疼痛和生活质量影响，包括阅读和驾驶问题。这项研究将利用来自维生素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因子试验，分别在20,000名50岁和55岁的男性和女性中测试海洋omega-3脂肪酸(465 mg/d二十碳五烯酸+375 mg/d二十二碳六烯酸)和维生素D3(胆钙素，2000IU/d)补充剂对癌症和心血管疾病的一级预防作用。从2011年7月开始，持续到2012年，愿意接受邀请函的符合条件的受访者将在一个月的磨合中登记，随后在磨合期间保持愿意、合格和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，参与者将获得新的药片供应和后续 关于健康终点依从性、副作用和发生率的UP问卷。我们建议确定重要试验中的流行(随机化前)和事件(随机化后)DED终点。VITAL-DED的主要特定目标是测试补充omega-3 FA是否：1)降低DED的发生率，2)通过缓解症状和对生活质量的其他影响改善DED的自然病史。二级目标将评估DED在美国的发病率，前瞻性地检查DED的自然历史，探索可能改变或影响补充omega-3 FA的影响的因素，评估DED和抑郁症的相互关系，并测试补充维生素D3在DED的发病率和自然历史中可能的独立或联合影响。这项研究响应了国家眼科研究所战略计划的一个项目重点，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；还解决了最近举行的2010年NEI关于眼痛和敏感性的研讨会中确定的几个问题。这些假说得到了令人信服的生物学基础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并改善其自然病程。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，可以对最有希望的DED预防药物的疗效进行可靠、有效和信息丰富的评估。鉴于我们在之前的大型简单试验中取得的成功，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，指导公共卫生和临床建议DED的预防和管理。