Supplemental Selenium and Vitamin E and Pulmonary Function
- Conditions
- Lung Diseases, ObstructiveChronic Obstructive Pulmonary DiseaseLung Diseases
- Interventions
- Dietary Supplement: Vitamin EDietary Supplement: SeleniumDietary Supplement: Selenium placeboDietary Supplement: Vitamin E placebo
- Registration Number
- NCT00063453
- Lead Sponsor
- Cornell University
- Brief Summary
To test whether supplementation with selenium and/or vitamin E affects pulmonary function.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 2920
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Vitamin E and selenium placebo Selenium placebo Vitamin E alone Selenium and vitamin E placebo Vitamin E placebo Selenium alone vitamin E Placebo and Selenium placebo Vitamin E placebo Double placebo Vitamin E and selenium placebo Vitamin E Vitamin E alone Selenium and vitamin E placebo Selenium Selenium alone Vitamin E and selenium Vitamin E Vitamin E and selenium combined Vitamin E and selenium Selenium Vitamin E and selenium combined vitamin E Placebo and Selenium placebo Selenium placebo Double placebo
- Primary Outcome Measures
Name Time Method Change in pulmonary function over time by arm of study Outcome is assessed at annual and bi-annual study visits, during in-person visit of participant to the study site. Over a period of about 36 to 48 months, participants are assessed between 3 and 4 times
- Secondary Outcome Measures
Name Time Method