Chronic Obstructive Pulmonary DiseasePhase 4NCT00186706
Selenium Supplementation in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 4 study testing Selenium in people with Chronic Obstructive Pulmonary Disease and Cardiovascular Disease, run by St. Joseph's Health Care London at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Cardiovascular Disease
- What is being tested?
- Selenium
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Nov 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Selenium Supplementation on Anti-Oxidant Levels in COPD Patients: A 12-Week, Randomized, Placebo-Controlled Trial
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.
Read the 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 (HR=5.6) 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.
- Being tested
- Selenium
- Keywords
- Selenium, Chronic Obstructive Pulmonaary Disease, Cardiovascular Disease, Anti-oxidant, Pulmonary
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeleniumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Health Care London
- Sponsor type
- University, hospital or other
- Collaborators
- Father Sean O'Sullivan Research Centre
- Investigators
- Marek J Smieja, MD PhD FRCPC, Principal investigator, Associate Professor, Dept. of Pathology & Molecular Medicine, McMaster University; Microbiologist & Infectious Disease Physician, Dept. of Laboratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186706
- Sponsor's protocol ID
- R.P. #04-2326
- Status last verified
- May 2008
- First submitted
- 10 Sep 2005
- Last updated
- 22 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Selenium Supplementation on Anti-Oxidant Levels in COPD Patients: A 12-Week, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00186706
- Acronym / sponsor ID
- R.P. #04-2326
- Keywords
- Selenium, Chronic Obstructive Pulmonaary Disease, Cardiovascular Disease, Anti-oxidant, Pulmonary
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- St. Joseph's Health Care LondonUniversity, hospital or other
- Collaborators
- Father Sean O'Sullivan Research Centre
- Study start
- Sep 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (HR=5.6) 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selenium | Drug | – |
Primary outcome
To determine whether 12 weeks of selenium supplementation increases GPx-1 levels compared with placebo
1 secondary outcome
To determine whether selenium affects respiratory symptoms and function, and measures of inflammatory and infections markers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marek J Smieja, MD PhD FRCPC principal investigator
Associate Professor, Dept. of Pathology & Molecular Medicine, McMaster University; Microbiologist & Infectious Disease Physician, Dept. of Laboratory Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selenium in people with Chronic Obstructive Pulmonary Disease and Cardiovascular Disease, run by St. Joseph's Health Care London at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether 12 weeks of selenium supplementation increases GPx-1 levels compared with placebo. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2008.