Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000412639
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
15/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Selenium and Coronary Artery Disease: Should we supplement high risk patients?
Scientific title
The Effect of Selenium Supplementation on Clinical Outcome in High Risk Cardiac Patients with Coronary Artery Disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 520 0
Condition category
Condition code
Cardiovascular 597 597 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Selenomethionine 100 mcg daily until:

-the patient undergoes surgical intervention or

-until one end point is reached

or

-until the end of the study (3 years).
Intervention code [1] 430 0
Other interventions
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 693 0
Death
Timepoint [1] 693 0
Measured during the intervention period
Primary outcome [2] 694 0
Myocardial infarction
Timepoint [2] 694 0
Measured during the intervention period
Primary outcome [3] 695 0
Early surgical or percutaneous intervention due to cardiac deterioration
Timepoint [3] 695 0
Measured during the intervention period
Secondary outcome [1] 1433 0
Selenium level and glutathione peroxidase activity.
Timepoint [1] 1433 0
At baseline and 3 months.

Eligibility
Key inclusion criteria
3 vessel disease proven by angiography, with no percutaneous or surgical intervention since diagnosis.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Valvular heart disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation is concealed using sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated; blocking
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 193 0
New Zealand
State/province [1] 193 0

Funding & Sponsors
Funding source category [1] 651 0
Charities/Societies/Foundations
Name [1] 651 0
Anderson charitable trust
Country [1] 651 0
Funding source category [2] 652 0
Commercial sector/Industry
Name [2] 652 0
Evelyn McInnes Estate
Country [2] 652 0
Funding source category [3] 653 0
Charities/Societies/Foundations
Name [3] 653 0
Caversham Foundation
Country [3] 653 0
New Zealand
Funding source category [4] 654 0
Charities/Societies/Foundations
Name [4] 654 0
Southland Medical Foundation
Country [4] 654 0
New Zealand
Primary sponsor type
Individual
Name
Dr Nathalie van Havre
Address
Country
Secondary sponsor category [1] 547 0
University
Name [1] 547 0
University of Otago
Address [1] 547 0
Country [1] 547 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1796 0
Otago/Southland
Ethics committee address [1] 1796 0
Ethics committee country [1] 1796 0
New Zealand
Date submitted for ethics approval [1] 1796 0
Approval date [1] 1796 0
Ethics approval number [1] 1796 0
Ethics committee name [2] 1797 0
Canterbury in progress
Ethics committee address [2] 1797 0
Ethics committee country [2] 1797 0
New Zealand
Date submitted for ethics approval [2] 1797 0
Approval date [2] 1797 0
Ethics approval number [2] 1797 0

Summary
Brief summary
New Zealand soil and food have a very low selenium content. New Zealanders also have low selenium levels in their blood. This is nothing new for Otago and Southland farmers who have been supplementing livestock for a long time.
In previous studies, low selenium has been linked with coronary artery disease. Selenium is essential to the function of a protein called glutathione peroxidase 1 (GPX1). This proteinÿ¿ÿ¢ÿ¿ÿ¿ÿ¿ÿ¿s function is to eliminate toxins in blood vessels. If selenium is low, GPX1 is low and toxins can accumulate and cause narrowing of blood vessels. Researchers at University of Otago have already shown that if selenium supplements are given to New Zealanders, the activity of the enzyme GPX1 increases. Moreover, a study published in the New England Journal of Medicine in 2003 showed that patients with coronary artery disease who have a low GPX1 activity have more ischemic complications (angina and myocardial infarct) than patients with a higher GPX1 activity.

Our main goal is to find out whether high risk cardiac patients who are given selenium supplements do better than patients who do not get supplements.
Because of the possible interaction between genotype and response to supplements, we are also planning to determine the characteristics of the GPX1 gene for each participant to the study. This could help us find out which patients would benefit from supplements the most. We are planning to enroll up to 400 patients over the next three years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35678 0
Address 35678 0
Country 35678 0
Phone 35678 0
Fax 35678 0
Email 35678 0
Contact person for public queries
Name 9619 0
Dr Nathalie van Havre
Address 9619 0
Southland Medical Foundation
W and GS Dick Senior Research Fellow
Cardiology Section
Department of Medical and Surgical Sciences
University of Otago
PO Box 913
Dunedin
Country 9619 0
New Zealand
Phone 9619 0
+64 3 4740999 (Ext. 8514)
Fax 9619 0
+64 3 4747641
Email 9619 0
nathalie.vanhavre@stonebow.otago.ac.nz
Contact person for scientific queries
Name 547 0
Dr Nathalie van Havre
Address 547 0
Southland Medical Foundation
W and GS Dick Senior Research Fellow
Cardiology Section
Department of Medical and Surgical Sciences
University of Otago
PO Box 913
Dunedin
Country 547 0
New Zealand
Phone 547 0
+64 3 4740999 (Ext. 8514)
Fax 547 0
+64 3 4747641
Email 547 0
nathalie.vanhavre@stonebow.otago.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.