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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: September 23, 2013
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
  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: Triple (Participant, 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 ]

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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063453


Sponsors and Collaborators
Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Patricia A. Cassano, PhD Cornell University
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT00063453     History of Changes
Obsolete Identifiers: NCT00241865, NCT00782678
Other Study ID Numbers: 151
R01HL071022 ( U.S. NIH Grant/Contract )
First Submitted: June 26, 2003
First Posted: June 30, 2003
Last Update Posted: September 23, 2013
Last Verified: September 2013

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