Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
The Respiratory Ancillary Study (RAS) to SELECT
To test whether supplementation with selenium and/or vitamin E affects pulmonary function.
BACKGROUND:
There is compelling evidence from observational epidemiologic studies that intakes of
nutrients with antioxidant properties are associated with reduced risks of chronic
obstructive disease (COPD) and increased lung function. This study is ancillary to the
multisite Selenium and Vitamin E Cancer Prevention Trial (SELECT), a 4-arm
placebo-controlled, double-blinded randomized trial in 35,000 men testing whether daily
supplementation with vitamin E (400mg alpha-tocopherol), selenium (200 micrograms
selenomethionine) or both vitamin E and selenium can prevent prostate cancer.
DESIGN NARRATIVE:
This study is ancillary to the multisite Selenium and Vitamin E Cancer Prevention Trial
(SELECT), a 4-arm placebo-controlled, double-blinded randomized trial in 35,000 men testing
whether daily supplementation with vitamin E (400mg alpha-tocopherol), selenium (200
micrograms selenomethionine) or both vitamin E and selenium can prevent prostate cancer. A
total of 3,000 SELECT participants will be enrolled for this respiratory ancillary study, and
data collection will be extended to include pulmonary function, respiratory disease, and
respiratory symptoms. Biological measures of nutrient exposure (serum vitamin E and selenium)
and plasma lipids (total and high-density lipoprotein cholesterol) will be collected on all
participants and oxidant burden (urinary F2-isoprostane) on a sub sample of heavy smokers and
men with COPD. The primary outcome will be change over about 36 months in forced expiratory
volume in the first second (FEV1). FEV1 is a valid and reliable measure of respiratory
function that strongly predicts COPD and mortality. Extensive data on diet and dietary
supplement use are being collected by the SELECT parent study. All specific aims examine
pre-specified contrasts between the 4 arms of the SELECT randomized trial. The underlying
hypothesis is that supplements will reduce the age related decline in FEV1 and thus at the
3-year follow-up FEV1, which will be tested in longitudinal and cross-sectional models. A
secondary aim considers whether the effect of supplementation is greater among smokers (high
burden of exogenous oxidants) who, by purposive selection of the study sites, will comprise
about 25% of the sample.
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