Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000197538
Ethics application status
Approved
Date submitted
18/05/2006
Date registered
26/05/2006
Date last updated
26/05/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Selenium, CAD, inflammation and endothelial function
Scientific title
Do selenium supplements improve inflammation and endothelial function markers in patients with coronary artery stenosis in Otago?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery stenosis 1173 0
Condition category
Condition code
Cardiovascular 1257 1257 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
oral selenomethionine supplements 100 mcg daily. duration of supplementation is 3 months.
Intervention code [1] 1049 0
Treatment: Other
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1695 0
Biochemical endothelial function markers Icam and Vcam
Timepoint [1] 1695 0
At 3 months
Secondary outcome [1] 3038 0
Glutathione peroxidase activity, peroxide and paraoxonase levels.
Timepoint [1] 3038 0
At 3 months.

Eligibility
Key inclusion criteria
Coronary artery stenosis at least 30% on any of the three major vessels.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
CABG after angiography, myocardial infarct in previous 48Hrsalready taking seleniumhemodynamically significant valvular diseasesurgery or trauma within the past month.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocks, simple randomization by using a computer generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 318 0
New Zealand
State/province [1] 318 0

Funding & Sponsors
Funding source category [1] 1374 0
Charities/Societies/Foundations
Name [1] 1374 0
Otago Medical Research Foundation
Country [1] 1374 0
New Zealand
Funding source category [2] 1375 0
University
Name [2] 1375 0
University of Otago School of Medicine Dean's bequest fund
Country [2] 1375 0
New Zealand
Funding source category [3] 1376 0
Charities/Societies/Foundations
Name [3] 1376 0
Southland Medical Research Foundation.
Country [3] 1376 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 1211 0
None
Name [1] 1211 0
none
Address [1] 1211 0
Country [1] 1211 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2729 0
Lower South Regional Ethics Committee- Dunedin Hospital
Ethics committee address [1] 2729 0
Ethics committee country [1] 2729 0
New Zealand
Date submitted for ethics approval [1] 2729 0
Approval date [1] 2729 0
17/05/2006
Ethics approval number [1] 2729 0
LRS/06/05/021

Summary
Brief summary
Patients undergoing cardiac catheterization in Dunedin will be informed about the research project. Patients who enter the study will receive either selenium or placebo (dummy tablet) for 3 months. Because this study is "double blind", neither the researchers nor the patients will know who is taking selenium and who is taking placebo until the end of the study. Blood samples will be taken at the start of the study and at three months. We will be able to tell whether selenium improves markers of inflammation and endothelial function in patients with coronary disease by measuring and comparing these markers on the two successive samples for the two groups. This is important because inflammation and endothelial function are linked to progression of heart disease and because there is good evidence that selenium may help reduce inflammation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36225 0
Address 36225 0
Country 36225 0
Phone 36225 0
Fax 36225 0
Email 36225 0
Contact person for public queries
Name 10238 0
Nathalie van Havre
Address 10238 0
Southland Medical Foundation
W and G S Dick Senior Research Fellow
Cardiology Section
Department of Medical and Surgical Sciences
University of Otago
PO Box 913
Dunedin
Tel: 64-3-474-0999 ext 8514
Country 10238 0
New Zealand
Phone 10238 0
+64 2 76627221
Fax 10238 0
+61 3 4747641
Email 10238 0
nathalie.vanhavre@stonebow.otago.ac.nz
Contact person for scientific queries
Name 1166 0
Nathalie van Havre
Address 1166 0
Southland Medical Foundation
W and G S Dick Senior Research Fellow
Cardiology Section
Department of Medical and Surgical Sciences
University of Otago
PO Box 913
Dunedin
Country 1166 0
New Zealand
Phone 1166 0
+64 2 76627221
Fax 1166 0
+61 3 4747641
Email 1166 0
nathalie.vanhavre@stonebow.otago.ac.nz

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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