Supplemental Selenium and Vitamin E and Pulmonary Function

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT00063453
First received: June 26, 2003
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Respiratory Ancillary Study (RAS) to SELECT

Resource links provided by NLM:


Further study details as provided by Cornell University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Effect of selenium and vitamin E supplementation on incidence of COPD [ 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 2920
Study Start Date: August 2003
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin E and placebo
Vitamin E alone
Dietary Supplement: Vitamin E
vitamin E (400 IU/day all rac-α-tocopheryl acetate)
Other Name: all rac-α-tocopheryl acetate
Experimental: Selenium and placebo
Selenium alone
Dietary Supplement: Selenium
selenium (200 μg/d L-selenomethionine)
Other Name: L-selenomethionine
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 Name: all rac-α-tocopheryl acetate
Dietary Supplement: Selenium
selenium (200 μg/d L-selenomethionine)
Other Name: L-selenomethionine
Placebo Comparator: Placebo and placebo
Double placebo

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063453

Sponsors and Collaborators
Cornell University
Investigators
Principal Investigator: Patricia A. Cassano, PhD Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT00063453     History of Changes
Other Study ID Numbers: 151, R01HL071022
Study First Received: June 26, 2003
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Selenium
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on April 23, 2014