Dietary Antioxidants and Infectious Disease

本研究的目的是确定是否 较高的饮食和补充摄入的维生素C或E，或 β-胡萝卜素与较低的感染率有关， 绝经后妇女。研究受试者是组的入组者 普吉特海湾健康合作社（GHC），一个位于西雅图的大型 健康维护组织，并筛选为 骨折干预试验（FIT），一项阿仑膦酸钠的随机试验， 其最近被批准用于治疗骨质疏松症。这 研究将使用GHC受试者记录的自动数据， 研究期间为1992年（FIT基线）至1997年。批准 从GHC人类受试者中获得 审查委员会和基金会出版物委员会。的 作为本合同的一部分， 建立一个数据集，以确定感染的发生， 1，517名研究对象。数据将从以下来源获得： GHC自动化数据库：药房（抗生素处方）， 实验室检查（尿液分析、全血细胞计数、培养），以及 利用率（ICD-9编码来自出院总结）。 正在对门诊药房数据进行分析。的 其他数据集将于6月至8月推出 1998.主要研究者将前往GHC一周， 8月，监督分析数据集的最终准备工作， 与西雅图的合作研究者进行讨论认证研究 将对研究结果进行检查。病历 将对受试者病历的随机样本进行审查， 评估用于识别感染的方法的有效性， 自动化数据。验证研究的统计分析 更大的项目将由校长 研究者与NIA和西雅图研究者合作。

The purpose of this study is to determine whether higher dietary and supplemental intake of vitamins C or E, or beta-carotene is associated with lower rates of infections in postmenopausal women. The study subjects are enrollees of Group Health Cooperative of Puget Sound (GHC), a large Seattle-based health maintenance organization, and were screenees for the Fracture Intervention Trial (FIT), a randomized trial of alendronate, which was recently approved for treatment of osteoporosis. This study will use automated data fromt he subjects records at GHC for the study period from 1992 (FIT baseline) through 1997. Approvals for this research have been obtained from the GHC Human Subjects Review Committee and from the FIT Publications Committee. The primary task that is being conducted as part of this contract is the setting up of a dataset to identify the occurrence of infections in the 1,517 study subjects. Data will be obtained from the following GHC automated databases: pharmacy (antibiotic prescriptions), laboratory (urinalysis, complete blood count, cultures), and utilization (ICD-9 codes from hospital discharge summary). Analysis is underway with the outpatient pharmacy data. The additional datasets will be forthcoming in June through August 1998. The Principal Investigator will go to GHC for one week in August to oversee the final preparation of the analytic dataset and to confer with the Seattle-based co-investigators. A validation study will be conducted to examine the study outcomes. Medical record reviews will be performed on a random sample of subjects' charts to assess the validity of the methods used to identify infections using the automated data. The statistical analyses for the validation study and the larger project will be conducted by the Principal Investigator in collaboration with NIA and Seattle investigators.