Prevention of Lung Function Decline With Vitamin E and Selenium - Respiratory Ancillary Study (RAS)
OBJECTIVES:
Primary
- To test longitudinally whether the decrease in FEV_1 over 3 years is lower among men
receiving daily supplementation with selenium compared to men receiving placebo on
SELECT clinical trial SWOG-S0000.
- To test longitudinally whether the decrease in FEV_1 over 3 years is lower among men
receiving daily supplementation with both selenium and vitamin E compared to men
receiving placebo.
- To test cross-sectionally whether FEV_1 is higher at 3 years post randomization among
men receiving daily supplementation with both selenium and vitamin E compared to men
receiving placebo.
- To test cross-sectionally whether FEV_1 is higher at 3 years post randomization among
men receiving daily supplementation with selenium compared to men receiving placebo.
Secondary
- To test longitudinally and cross-sectionally whether there is a difference in FEV_1
among men receiving daily supplementation with vitamin E compared to men receiving
placebo.
- To test longitudinally and cross-sectionally whether there is a difference in FEV_1
among men receiving daily supplementation with both selenium and vitamin E compared to
men receiving selenium alone or vitamin E alone.
- To evaluate the effect of daily supplementation with selenium and/or vitamin E in a
subgroup of current smokers.
- To characterize the shape of the early response of FEV_1 to supplement use in a subset
of participants.
- To evaluate whether the effect of daily supplementation with selenium and vitamin E in
a subgroup of current smokers is mediated by the level of oxidative stress as measured
by urinary F2-isoprostanes.
- To collect blood samples to allow future investigation of additional markers of
oxidative stress, including oxidized lipoproteins, to understand whether proposed
mediated pathways indeed explain intervention effects.
OUTLINE: This is a multicenter study.
Participants undergo pulmonary function testing by spirometer and complete a questionnaire
on respiratory symptoms at baseline and then periodically for up to 3 years. Participants
also undergo urine and blood sample collection for evaluation of oxidative stress biomarkers
(e.g., urinary F2-isoprostanes and plasma oxidized low-density lipoproteins). Blood samples
will be stored for future research studies.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Rate of decline of FEV1
Assessment of pulmonary function testing (spirometry) at multiple time points over a 3-year period (longitudinal)
FEV1 over a 3-year period
No
Patricia A. Cassano, PhD
Study Chair
Weill Medical College of Cornell University
United States: Federal Government
CDR0000617786
NCT00782678
June 2004
July 2012
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