Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186706
Status:
COMPLETED
Last Update Posted:
2008-05-22
First Post:
2005-09-10
Brief Title:
Selenium Supplementation in Chronic Obstructive Pulmonary Disease COPD Patients
Sponsor:
St Josephs Health Care London
Organization:
St Josephs Healthcare Hamilton
Study Overview
Official Title:
The Effect of Selenium Supplementation on Anti-Oxidant Levels in COPD Patients A 12-Week Randomized Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2008-05
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:
Does an oral selenium supplement increase blood levels of antioxidants in patients with established smoking-related lung disease
Members of our study group recently discovered that elevated levels of the anti-oxidant GPx-1 may be protective against heart disease We are studying whether selenium supplementation will improve GPx-1 levels
Members of our study group recently discovered that elevated levels of the anti-oxidant GPx-1 may be protective against heart disease We are studying whether selenium supplementation will improve GPx-1 levels
Detailed Description:
Patients with chronic obstructive pulmonary disease COPD are at high risk for atherosclerotic heart disease in part because of their nearly universal exposure to heavy smoking and in part to other incompletely understood mechanisms which may include inflammation and anti-oxidant status
Smoking markedly affects both circulating inflammatory markers concentrations and the anti-oxidant glutathione peroxidase-1 GPx-1 We hypothesize that smoking-related inflammation and anti-oxidant consumption lead to both cardiovascular CV and respiratory disease In a recent study we Blankenberg et al found that higher levels of GPx-1 were associated with lower rates af future CV events and death GPx-1 levels were lower among smokers and the combination of current smoking and GPx-1 levels below the median was strongly HR56 and significantly associated with future CV events and death
There is a biological and epidemiological rationale to study selenium supplementation for CV protection GPx-1 is a selenium-dependent enzyme and data support the hypothesis that selenium supplementation increases GPx activity in various diseases Furthermore epidemiologic studies have discovered an inverse association between selenium content in soil and CV incidence and mortality We hypothesize that selenium supplementation will elevate intra-erythrocytic GPx-1 levels in COPD patients and ultimately retard CV progression
In this study we will test the first component of this assertion In a randomized placebo-controlled trial we will determine whether 12 weeks of selenium supplementation increases GPx-1 levels among 120 COPD patients If successful this study may lead to future large clinical trials to assess whether selenium an inexpensive and safe mineral improves clinical outcomes in cardiovascular and respiratory disease
Smoking markedly affects both circulating inflammatory markers concentrations and the anti-oxidant glutathione peroxidase-1 GPx-1 We hypothesize that smoking-related inflammation and anti-oxidant consumption lead to both cardiovascular CV and respiratory disease In a recent study we Blankenberg et al found that higher levels of GPx-1 were associated with lower rates af future CV events and death GPx-1 levels were lower among smokers and the combination of current smoking and GPx-1 levels below the median was strongly HR56 and significantly associated with future CV events and death
There is a biological and epidemiological rationale to study selenium supplementation for CV protection GPx-1 is a selenium-dependent enzyme and data support the hypothesis that selenium supplementation increases GPx activity in various diseases Furthermore epidemiologic studies have discovered an inverse association between selenium content in soil and CV incidence and mortality We hypothesize that selenium supplementation will elevate intra-erythrocytic GPx-1 levels in COPD patients and ultimately retard CV progression
In this study we will test the first component of this assertion In a randomized placebo-controlled trial we will determine whether 12 weeks of selenium supplementation increases GPx-1 levels among 120 COPD patients If successful this study may lead to future large clinical trials to assess whether selenium an inexpensive and safe mineral improves clinical outcomes in cardiovascular and respiratory disease
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