Supplemental Selenium and Vitamin E and Pulmonary Function

Study Overview
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Brief Summary
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To test whether supplementation with selenium and/or vitamin E affects pulmonary function.

Detailed Description
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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.

Official Title
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The Respiratory Ancillary Study (RAS) to SELECT

Conditions
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Chronic Obstructive Pulmonary Disease, Lung Diseases, Lung Diseases, Obstructive

Intervention / Treatment
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* Dietary Supplement: Vitamin E
* Dietary Supplement: Selenium
* Dietary Supplement: Vitamin E placebo
* Dietary Supplement: Selenium placebo


Participation Criteria
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Eligibility Criteria
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Eligibility criteria: age ≥ 55 y (≥ 50 y in African-Americans) serum prostate-specific antigen ≤ 4ng/mL no clinical evidence of prostate cancer Exclusion criteria: Off both SELECT supplements

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin E and selenium placebo<br>Vitamin E alone | Dietary Supplement: Vitamin E<br>* vitamin E (400 IU/day all rac-α-tocopheryl acetate)<br>* Other names: all rac-α-tocopheryl acetate;Dietary Supplement: Selenium placebo<br>* placebo<br>* Other names: placebo;|
| Experimental: Selenium and vitamin E placebo<br>Selenium alone | Dietary Supplement: Selenium<br>* selenium (200 μg/d L-selenomethionine)<br>* Other names: L-selenomethionine;Dietary Supplement: Vitamin E placebo<br>* placebo<br>* Other names: Placebo;|
| Experimental: Vitamin E and selenium<br>Vitamin E and selenium combined | Dietary Supplement: Vitamin E<br>* vitamin E (400 IU/day all rac-α-tocopheryl acetate)<br>* Other names: all rac-α-tocopheryl acetate;Dietary Supplement: Selenium<br>* selenium (200 μg/d L-selenomethionine)<br>* Other names: L-selenomethionine;|
| Placebo Comparator: vitamin E Placebo and Selenium placebo<br>Double placebo | Dietary Supplement: Vitamin E placebo<br>* placebo<br>* Other names: Placebo;Dietary Supplement: Selenium placebo<br>* placebo<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |