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Supplemental Selenium and Vitamin E and Pulmonary Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00063453
First Posted: June 30, 2003
Last Update Posted: December 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Cornell University
June 26, 2003
June 30, 2003
December 12, 2017
August 2003
August 2010   (Final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00063453 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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 ]
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
Not Provided
 
Supplemental Selenium and Vitamin E and Pulmonary Function
The Respiratory Ancillary Study (RAS) to SELECT
To test whether supplementation with selenium and/or vitamin E affects pulmonary function.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Chronic Obstructive Pulmonary Disease
  • Lung Diseases
  • Lung Diseases, Obstructive
  • 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
  • Dietary Supplement: Vitamin E placebo
    placebo
    Other Name: Placebo
  • Dietary Supplement: Selenium placebo
    placebo
    Other Name: placebo
  • Experimental: Vitamin E and selenium placebo
    Vitamin E alone
    Interventions:
    • Dietary Supplement: Vitamin E
    • Dietary Supplement: Selenium placebo
  • Experimental: Selenium and vitamin E placebo
    Selenium alone
    Interventions:
    • Dietary Supplement: Selenium
    • Dietary Supplement: Vitamin E placebo
  • Experimental: Vitamin E and selenium
    Vitamin E and selenium combined
    Interventions:
    • Dietary Supplement: Vitamin E
    • Dietary Supplement: Selenium
  • Placebo Comparator: vitamin E Placebo and Selenium placebo
    Double placebo
    Interventions:
    • Dietary Supplement: Vitamin E placebo
    • Dietary Supplement: Selenium placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2920
August 2010
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
50 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00063453
151
R01HL071022 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Cornell University
Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Patricia A. Cassano, PhD Cornell University
Cornell University
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP