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

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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.