Vitamin E Trial in Persons with Down Syndrome: Sharing Data with the Research Community

唐氏综合症患者的维生素 E 试验：与研究界共享数据

• 批准号: 10658587
• 负责人: HOWARD F. ANDREWS
• 金额: $ 25.7万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-15 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10658587
• 关键词: Adult; Alzheimer' s Disease; Biological Markers; Blood; Clinical; Clinical Data; Clinical Trials; Code; Collaborations; Communities; Controlled Clinical Trials; Data; Data Coordinating Center; Database Management Systems; Development; Documentation; Double-Blind Method; Down Syndrome; Ensure; Female; Funding; Grant; Health; Health Insurance Portability and Accountability Act; Individual; International; Investigation; Laboratories; Lead; Leadership; Longevity; Manuscripts; Medical center; Metadata; Oral; Participant; Persons; Phenotype; Placebos; Preparation; Procedures; Process; Protocols documentation; Publications; Quality of life; Randomized; Research; Research Personnel; Schedule; Secure; Training; United States National Institutes of Health; Universities; Vitamin E; Work; clinical research site; cohort; data de-identification; data exchange; data format; data sharing; design; improved; instrument; male; meetings; recruit; relational database; repository; sharing platform; timeline

ABSTRACT The proposed project will contribute comprehensive data collected in a 10-year clinical trial to the NIH-funded INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project, which seeks to improve health and quality-of-life for individuals with Down syndrome. Transferring data from the Vitamin E Trial in Persons with Down Syndrome will facilitate data sharing within the research community through the INCLUDE Data Coordinating Center (DCC). The Vitamin E Trial in Persons with Down Syndrome was funded in September 2000 and ended in April 2010; it was supported through NIH grant R01AG016831 over two 5-year funding periods. A randomized, double-blind controlled clinical trial was conducted at 21 clinical sites, and researchers trained in research procedures recruited adults with DS older than 50 years to participate. Participants were randomly assigned to receive 1,000 IU of vitamin E orally twice daily for 3 years or identical placebo and were evaluated at 6 month intervals for the duration of the trial. All clinical data and results of blood-based laboratory analyses generated in the Vitamin E Trial were entered and stored in a secure relational database system maintained by the Data Coordinating Center (DCC) serving the Columbia University Irving Medical Center (CUIMC). Dr. Howard Andrews, PI of the proposed project, contributed to the design of the original Trial, oversaw the development and implementation of the relational database that houses Trial data, and participated in the preparation of the manuscript describing the results of the Trial. In the proposed initiative to share Vitamin E Trial data with INCLUDE, Dr. Andrews, in close collaboration with the INCLUDE DCC, will lead a team that will fully de-identify the Trial data and provide extensive documentation, including an annotated codebook and meta-data describing the trial protocol and results generated to date. The transfer of Vitamin E trial data will be a significant contribution to the repository of research on individuals with Down Syndrome available through INCLUDE.

摘要 该项目将为NIH资助的一项为期10年的临床试验提供全面的数据。 了解唐氏综合征（INCLUDE）项目的整个生命周期中共病情况的调查， 旨在改善唐氏综合症患者的健康和生活质量。正在从 唐氏综合症患者的维生素E试验将通过以下方式促进研究界内部的数据共享 包括数据协调中心（DCC）。 唐氏综合症患者的维生素E试验 2000年9月资助，2010年4月结束;它通过NIH赠款R 01 AG 016831支持，超过两个月 5-年融资周期。在21个临床研究中心进行了随机、双盲对照临床试验， 接受过研究程序培训的研究人员招募了年龄超过50岁的DS成年人参与研究。 参与者被随机分配接受1,000 IU维生素E口服，每天两次，持续3年或相同时间。 安慰剂，并在试验期间每隔6个月进行评价。 输入维生素E试验中生成的所有临床数据和基于血液的实验室分析结果 并存储在由数据协调中心（DCC）维护的安全关系数据库系统中， 哥伦比亚大学欧文医学中心（CUIMC）。霍华德安德鲁斯博士，拟议项目的PI， 参与了最初试验的设计，监督了关系试验的开发和实施。 储存试验数据的数据库，并参与了描述 庭审 在与INCLUDE分享维生素E试验数据的提议中，Andrews博士与 INCLUDE DCC将领导一个团队，该团队将完全去识别试验数据并提供大量文件， 包括注释的码本和描述试验方案的元数据以及迄今为止产生的结果。的 维生素E试验数据的转移将对研究个人的知识库做出重大贡献， 唐氏综合症可通过INCLUDE获得。