Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063453
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2003-06-26
Brief Title:
Supplemental Selenium and Vitamin E and Pulmonary Function
Sponsor:
Cornell University
Organization:
Cornell University
Study Overview
Official Title:
The Respiratory Ancillary Study RAS to SELECT
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To test whether supplementation with selenium andor vitamin E affects pulmonary function
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 35000 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 35000 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 3000 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
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 35000 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 35000 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 3000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL071022 | NIH | None | httpsreporternihgovquickSearchR01HL071022 |