NCT00186706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2005

Typical duration for phase_4 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

Enrollment Period

2.2 years

First QC Date

September 10, 2005

Last Update Submit

May 21, 2008

Conditions

Chronic Obstructive Pulmonary DiseaseCardiovascular Disease

Keywords

SeleniumChronic Obstructive Pulmonaary DiseaseCardiovascular DiseaseAnti-oxidantPulmonary

Outcome Measures

Primary Outcomes (1)

  • To determine whether 12 weeks of selenium supplementation increases GPx-1 levels compared with placebo

Secondary Outcomes (1)

  • To determine whether selenium affects respiratory symptoms and function, and measures of inflammatory and infections markers.

Interventions

SeleniumDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCardiovascular Diseases

Interventions

Selenium

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMinerals

Study Officials

  • Marek J Smieja, MD PhD FRCPC

    Associate Professor, Dept. of Pathology & Molecular Medicine, McMaster University; Microbiologist & Infectious Disease Physician, Dept. of Laboratory Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

September 1, 2005

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

CA(1)