Effects of Selenium and Vitamin E Supplements on Lung Function and Chronic Obstructive Pulmonary Disease (RAS)

This study has been terminated.
(no effect on SELECT primary endpoint prostate cancer)
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT00241865
First received: October 17, 2005
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to evaluate the effectiveness of selenium and vitamin E supplements in reducing lung function decline in men.


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

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

Resource links provided by NLM:


Further study details as provided by Cornell University:

Primary Outcome Measures:
  • Rate of decline in forced expiratory volume in first second (FEV1) [ Time Frame: Measured three times in 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • COPD incidence [ Time Frame: Measured at approximately 7 years ] [ Designated as safety issue: No ]
  • Rate of decline in forced expiratory flow rate (FEF25-75) [ Time Frame: Measured over 36 months of followup ] [ Designated as safety issue: No ]

Enrollment: 2920
Study Start Date: June 2004
Study Completion Date: December 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Selenium + Vitamin E Placebo
l-selenomethionine 200 micrograms daily and placebo matching active vitamin E in taste and appearance (but contains no active ingredients)
Dietary Supplement: Selenium
l-selenomethionine 200 micrograms daily
Dietary Supplement: Vitamin E placebo
matches vitamin E active intervention in taste and appearance but contains no active ingredients
Experimental: Vitamin E + Selenium Placebo
dl-alpha-tocopherol acetate 400 milligrams (mg), which is equivalent to 400 International Units (IU) per day and placebo matching active selenium in taste and appearance (but contains no active ingredients)
Dietary Supplement: Vitamin E
dl-alpha-tocopherol acetate 400 milligrams (mg), which is equivalent to 400 International Units (IU) per day
Dietary Supplement: Selenium placebo
placebo matching selenium active intervention in taste and appearance but contains no active ingredients
Experimental: Selenium + Vitamin E
both l-selenomethionine 200 micrograms daily and dl-alpha-tocopherol acetate 400 milligrams (mg), which is equivalent to 400 International Units (IU) per day
Dietary Supplement: Vitamin E
dl-alpha-tocopherol acetate 400 milligrams (mg), which is equivalent to 400 International Units (IU) per day
Dietary Supplement: Selenium
l-selenomethionine 200 micrograms daily
Placebo Comparator: Vitamin E Placebo + Selenium Placebo
placebo matching active selenium in taste and appearance (but contains no active ingredients) and placebo matching active vitamin E in taste and appearance (but contains no active ingredients)
Dietary Supplement: Selenium placebo
placebo matching selenium active intervention in taste and appearance but contains no active ingredients
Dietary Supplement: Vitamin E placebo
matches vitamin E active intervention in taste and appearance but contains no active ingredients

Detailed Description:

BACKGROUND:

Observational epidemiologic studies provide compelling evidence suggesting that high antioxidant intake is associated with reduced risk of chronic obstructive pulmonary disease (COPD) and increased lung function.

DESIGN NARRATIVE:

The purpose of this study is two-fold. First, the study will longitudinally test whether: 1) the decrease in FEV1 over 3 years is lower among men receiving daily supplementation with 200 µg selenium compared to men receiving placebo; and 2) the decrease in FEV1 over 3 years is lower among men receiving daily supplementation with both 200 µg selenium and 400 mg vitamin E compared to men receiving placebo. Second, the study will cross-sectionally test, at 3 years post-randomization, whether: 1) FEV1 is higher among men receiving daily supplementation with 200 µg selenium and 400 mg vitamin E compared to men receiving placebo; and 2) FEV1 is higher among men receiving daily supplementation with 200 µg selenium compared to men receiving placebo.

The primary outcome of this study will be pulmonary function decline, which will be studied in 3,000 Selenium and Vitamin E Cancer Prevention Trial (SELECT) men at 18 SELECT sites.

The key secondary outcome will be COPD and asthma occurrence in the 35,000 men of the SELECT trial. Data on outcome occurrence will be updated at each biannual visit.

This study is an ancillary to the SELECT study (selenium and vitamin E supplements being studied for effects on prostate cancer prevention), which withdrew supplements from all participants in October 2008 due to no effect on prostate cancer. Data collection continues in both SELECT and in this study in the post-supplementation period until researchers have completed pulmonary function testing (three measurements in 3 years) on all participants. Ultimately, the trial analysis will examine whether treatment affected the endpoint in the intervention period, and whether the effect is attenuated in the post-supplementation period.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active SELECT participant and on supplements (defined as taking one or both of the SELECT study supplements)
  • Meets the eligibility requirements for registration (e.g., within certain time windows from annual visits, having signed informed consent for Respiratory Ancillary Study [RAS], at a site which has concurrent Institutional Review Board [IRB] approval for RAS)
  • Registered at SELECT randomization (within 28 days after SELECT randomization, or at plus or minus 28 days [within the contact window] of their SELECT annual visits 020, 030, or 040)
  • Registered and followed for RAS at the same site at which they are being followed for SELECT
  • Agree to provide a blood and urine sample for submission to central laboratories
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241865

Locations
United States, California
UCSD
La Jolla, California, United States, 92093
Moores Cancer Center/UCSD
La Jolla, California, United States, 92093
Harbor UCLA
Torrance, California, United States, 90502
United States, District of Columbia
VAMC Washington DC
Washington, District of Columbia, United States, 20422
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612-3824
West Side VA Medical Oncology
Chicago, Illinois, United States, 60612
United States, Kansas
Wichita CCOP
Wichita, Kansas, United States, 67214
United States, Minnesota
Minneapolis VAMC
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Kansas City VAMC
Kansas City, Missouri, United States, 64128
United States, New York
Cornell University
Ithaca, New York, United States, 14853
SUNY Stony Brook
Stony Brook, New York, United States, 11733
United States, South Carolina
Upstate Carolina CCOP
Spartanburg, South Carolina, United States, 29303
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77230-1439
United States, Washington
Swedish Hospital
Seattle, Washington, United States, 98104
VAMC Puget Sound
Seattle, Washington, United States, 98108
Canada, Ontario
London HSC
London, Ontario, Canada, N6A 3N7
London RCC
London, Ontario, Canada, N6A 3N7
Canada
Centre de Recherche
Quebec, Canada, G1S 2L6
Puerto Rico
Altamira Family Med
Rio Piedras, Puerto Rico, 00966
Sponsors and Collaborators
Cornell University
Investigators
Study Chair: Patricia A. Cassano, PhD Cornell University
  More Information

Additional Information:
Publications:
Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT00241865     History of Changes
Other Study ID Numbers: 331, R01HL071022, 00782678
Study First Received: October 17, 2005
Last Updated: June 24, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
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 17, 2014