Age Related Eye Disease Study 2 - Follow-on Study

年龄相关眼病研究 2 - 后续研究

基本信息

批准号：
9175773
负责人：
TRACI E CLEMONS
金额：
$ 36.11万
依托单位：
THE EMMES COMPANY, LLC
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-26 至 2016-09-25
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9175773
关键词：
Ancillary Study Archives Ascorbic Acid Authorization documentation Back Beta Carotene Calendar Cataract Cataract Extraction Certification Cessation of life Collaborations Communication Consent Forms Consultations Contractor Contracts Data Data Analyses Data Collection Data Set Databases Diagnosis Diagnostic Disease Documentation Dose Drug Formulations Electronics Enrollment Ensure Event Eye diseases Health Health Insurance Portability and Accountability Act Individual Information Technology Informed Consent Life Style Link Lutein Malignant Neoplasms Malignant neoplasm of lung Manuals Medical Medical Records Methods Modification Monitor Nutritional Study Oral Outcome Paper Participant Pathology Performance Physicians Policies Press Releases Procedures Process Protocols documentation Publications Randomized Controlled Clinical Trials Recording of previous events Reporting Resources Retinal Risk Safety Schedule Secure Security Services Site Slide Source Surveys System Telephone Interviews Testing Training Translational Research Update Validation Visit Vitamins Writing Zinc age related aged base clinical research site cohort data management electronic data experience follow-up indexing lens meetings mortality randomized trial therapy development web site zeaxanthin

项目摘要

AREDS2 is one of the longest and perhaps the largest randomized controlled clinical trial of lutein/zeaxanthin. The AREDS2 cohort provides valuable resources with which to assess safety and efficacy data on use of these compounds. A central focus will be on ocular- (retinal- and lens-based) and cancer-based endpoints. In 2009, Satia et al. reported an increased risk of lung cancer associated with long term lutein supplement use participants of the VITamins And Lifestyle (VITAL) Study aged 50 to 76 years.a As AREDS2 is a randomized controlled clinical trial, additional follow-up of study participants would permit us to determinate whether high-dose oral lutein supplement use increases risk of lung cancer. Information regarding mortality will be collected through telephone interviews and the National Death Index search. We will also use this opportunity to ask for the ocular outcomes by asking at the telephone interview for cataract surgery and treatment for AMD. Mortality is associated with ocular disease, specifically advanced AMD and cataract, as demonstrated by our previous randomized trial of the AREDS formulation (Vitamins C, E, beta-carotene, and zinc) for AMD and cataract.

AREDS2是Lutein/Zeaxanthin的最长，也许是最大的随机对照临床试验之一。 AREDS2队列提供了宝贵的资源，以评估使用这些化合物的安全性和有效性数据。中心重点将放在眼部（视网膜和镜头）和基于癌症的终点上。 2009年，萨蒂亚（Satia）等人。据报道，与长期的长期丽丝蛋白补充剂有关维生素和生活方式（Vital）研究（Vital）研究的风险增加了50至76岁的研究。A作为AREDS2是一项随机对照临床试验，研究参与者的额外随访允许我们确定高剂量口服le丽丝蛋白补充剂的使用是否会增加肺癌的风险。有关死亡率的信息将通过电话采访和国家死亡指数搜索收集。我们还将利用这个机会来询问眼部结果，要求在电话采访中进行白内障手术和AMD治疗。死亡率与眼科疾病，特别是晚期AMD和白内障有关，如我们先前对AMD和白内障的AREDS配方（维生素C，E，β-胡萝卜素和锌）的随机试验所证明的那样。