Status:
COMPLETED
Selenium Supplementation in Chronic Obstructive Pulmonary Disease (COPD) Patients
Lead Sponsor:
St. Joseph's Health Care London
Collaborating Sponsors:
Father Sean O'Sullivan Research Centre
Conditions:
Chronic Obstructive Pulmonary Disease
Cardiovascular Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE4
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 ...
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...
Eligibility Criteria
Inclusion
- Aged 40 years or older (no upper limit).
- Established Respirologist-diagnosed mild or moderate COPD, according to the Canadian Thoracic Society (CTS) Lung Function Guidelines.(33) For a diagnosis of mild COPD, patients must have FEV1 60% to 79% predicted and FEV1 / FVC \< 0.7. For a diagnosis of moderate COPD, patients must have FEV1 40% to 59% predicted and FEV1 / FVC \< 0.7.
- Current or former smokers with \> 20 pack-year smoking history.
- Ability to provide informed consent.
- Women subjects must be post-menopausal.
Exclusion
- Current or recent (within 4 weeks) acute exacerbation of chronic bronchitis
- Current daily use of mineral or vitamin + mineral supplements or other natural health products that provide a daily dose of selenium that is greater than 100 µg
- Current daily use of \>5000 U of vitamin A, \>1000 mg of vitamin C, or \>800 U vitamin E
- Known significant co-morbidity such as renal (creatinine \> 150 mol/L) or hepatic disease (AST or ALT \>3 times normal). Measurement of these will be a requirement of the study. Creatinine and Alanine aminotransferase (ALT) will be measured at the beginning and at the end of the study.
- Known or suspected active cancer other than non-melanoma skin cancer.
- Other concurrent major respiratory diagnosis other than COPD/asthma.
- Plan to start statin drugs during the 12 weeks of study drug (may enroll if statins started \>1 month before current study enrollment or deferred until study completion).
- Consumption of brazil nuts.
- Individuals who have homocystinuria
- On niacin at a daily dose of 500 mg or higher for hyperlipidemia.
- If you have allergies to products that contain dicalcium phosphate, talc sugarloaf, steric acid, or silica.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00186706
Start Date
September 1 2005
End Date
November 1 2007
Last Update
May 22 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6