Supplemental Selenium and Vitamin E and Pulmonary Function

Sponsor

Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT00063453

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

2,920

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

To test whether supplementation with selenium and/or vitamin E affects pulmonary function.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Lung Diseases Lung Diseases, Obstructive	Dietary Supplement: Vitamin E Dietary Supplement: Selenium Dietary Supplement: Vitamin E placebo Dietary Supplement: Selenium placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2920 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Respiratory Ancillary Study (RAS) to SELECT

Study Start Date :

Aug 1, 2003

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin E and selenium placebo Vitamin E alone	Dietary Supplement: Vitamin E vitamin E (400 IU/day all rac-α-tocopheryl acetate) Other Names: all rac-α-tocopheryl acetate Dietary Supplement: Selenium placebo placebo Other Names: placebo
Experimental: Selenium and vitamin E placebo Selenium alone	Dietary Supplement: Selenium selenium (200 μg/d L-selenomethionine) Other Names: L-selenomethionine Dietary Supplement: Vitamin E placebo placebo Other Names: Placebo
Experimental: Vitamin E and selenium Vitamin E and selenium combined	Dietary Supplement: Vitamin E vitamin E (400 IU/day all rac-α-tocopheryl acetate) Other Names: all rac-α-tocopheryl acetate Dietary Supplement: Selenium selenium (200 μg/d L-selenomethionine) Other Names: L-selenomethionine
Placebo Comparator: vitamin E Placebo and Selenium placebo Double placebo	Dietary Supplement: Vitamin E placebo placebo Other Names: Placebo Dietary Supplement: Selenium placebo placebo Other Names: placebo

Outcome Measures

Primary Outcome Measures

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]

Other Outcome Measures

Effect of selenium and vitamin E supplementation on incidence of COPD [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]
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