Supplemental Selenium and Vitamin E and Pulmonary Function

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Respiratory Ancillary Study (RAS) to SELECT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00063453
• Other study ID #: 151
• Secondary ID: R01HL071022
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2003
• Last updated: December 8, 2017
• Start date: August 2003
• Est. completion date: August 2010

Study information

• Verified date: December 2017
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT00241865
• NCT00782678

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2920
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Dietary Supplement:
• Vitamin E
vitamin E (400 IU/day all rac-a-tocopheryl acetate)
• Selenium
selenium (200 µg/d L-selenomethionine)
• Vitamin E placebo
placebo
• Selenium placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cornell University	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	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
Primary	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

External Links

•   Patricia A. Cassano homepage