Supplemental Selenium and Vitamin E and Pulmonary Function - Tabular View

Tracking Information
First Received Date ^ICMJE	June 26, 2003
Last Updated Date	January 3, 2006
Start Date ^ICMJE	August 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00063453 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Supplemental Selenium and Vitamin E and Pulmonary Function
Official Title ^ICMJE
Brief Summary	To test whether anti-oxidant supplementation with selenium and/or vitamin E affects pulmonary function.
Detailed Description	BACKGROUND: There is compelling evidence from observational epidemiologic studies that high antioxidant intakes 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 32,400 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 32,400 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 between baseline and year 3 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 antioxidants will reduce the age related decline in FEV1 and thus at the 3-year follow-up FEV1 will be higher in the groups receiving antioxidant supplements compared to controls. 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 25% of the sample.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double-Blind, Placebo Control
Condition ^ICMJE	Chronic Obstructive Pulmonary Disease Lung Diseases Lung Diseases, Obstructive
Intervention ^ICMJE	Behavioral: dietary supplements
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE
Completion Date	July 2008
Primary Completion Date
Eligibility Criteria ^ICMJE	No eligibility criteria
Gender	Male
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00063453
Responsible Party
Study ID Numbers ^ICMJE	151
Study Sponsor ^ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Heart, Lung, and Blood Institute (NHLBI)
Verification Date	December 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP