Selenium Supplementation in Chronic Obstructive Pulmonary Disease (COPD) Patients

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Health Care London
• Collaborator: Father Sean O'Sullivan Research Centre
• Treatments: Antioxidants; Selenium

Criteria

Inclusion Criteria:

1. Aged 40 years or older (no upper limit).

2. 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.

3. Current or former smokers with > 20 pack-year smoking history.

4. Ability to provide informed consent.

5. Women subjects must be post-menopausal.

Exclusion Criteria:

1. Current or recent (within 4 weeks) acute exacerbation of chronic bronchitis

2. 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

3. Current daily use of >5000 U of vitamin A, >1000 mg of vitamin C, or >800 U vitamin E

4. 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.

5. Known or suspected active cancer other than non-melanoma skin cancer.

6. Other concurrent major respiratory diagnosis other than COPD/asthma.

7. 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).

8. Consumption of brazil nuts.

9. Individuals who have homocystinuria

10. On niacin at a daily dose of 500 mg or higher for hyperlipidemia.

11. If you have allergies to products that contain dicalcium phosphate, talc sugarloaf, steric acid, or silica.