Dietary Antioxidants and Infectious Disease

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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.