A Phase 3 interventional study of Vitamin E and Selenium in Chronic Obstructive Pulmonary Disease, Lung Diseases and Lung Diseases, Obstructive, sponsored by Cornell University. Completed. Open to male participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-12.
Sponsored by Cornell University · Phase 3, Interventional, and Prevention
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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 2,920 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Cornell University is the lead sponsor of 103 studies on the registry; 18 are open to participants now.
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Eligibility criteria:
Exclusion criteria:
Vitamin E alone
Dietary Supplement: Vitamin E · Dietary Supplement: Selenium placebo
Selenium alone
Dietary Supplement: Selenium · Dietary Supplement: Vitamin E placebo
Vitamin E and selenium combined
Dietary Supplement: Vitamin E · Dietary Supplement: Selenium
Double placebo
Dietary Supplement: Vitamin E placebo · Dietary Supplement: Selenium placebo
vitamin E (400 IU/day all rac-α-tocopheryl acetate)
Also known as: all rac-α-tocopheryl acetate
selenium (200 μg/d L-selenomethionine)
Also known as: L-selenomethionine
placebo
Also known as: Placebo
placebo
Also known as: placebo
Change in pulmonary function over time by arm of study
Time frame: 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
Effect of selenium and vitamin E supplementation on incidence of COPD
The incidence of COPD will be assessed in the full SELECT trial, given this ancillary study added questionnaire data to assess self-reported incidence of lung disease in the full 35,000 participants
Time frame: Questionnaire data on incident lung disease is assessed at annual and biannual study visits, in all SELECT participants. These questionnaire data were collected through the end of SELECT active follow-up, which was December 2010
No study locations are listed for this record.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Vitamin E · Selenium
Pulmonary Disease, Chronic Obstructive →