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Trial registered on ANZCTR
Registration number
ACTRN12605000744651
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
15/11/2005
Date last updated
17/06/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Antioxidant Study
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Scientific title
A randomised controlled trial to evaluate the effects of Vitamin E and/or Lipoic acid in people with the Metabolic Syndrome to improve markers of insulin resistance and oxidative stress
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Secondary ID [1]
262396
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
The Metabolic Syndrome
896
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Condition category
Condition code
Metabolic and Endocrine
964
964
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0
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Normal metabolism and endocrine development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Vitamin E/Lipoic acid for 12 months
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Intervention code [1]
399
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Treatment: Drugs
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Comparator / control treatment
Placebo for 12 months.
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Control group
Placebo
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Outcomes
Primary outcome [1]
1278
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Markers of Insulin Resistance
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Assessment method [1]
1278
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Timepoint [1]
1278
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Assessed at the conclusion of study at 12 months.
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Primary outcome [2]
1279
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Reversal of the Metabolic Syndrome
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Assessment method [2]
1279
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Timepoint [2]
1279
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Assessed at the conclusion of study at 12 months.
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Secondary outcome [1]
2308
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Inflammatory markers
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Assessment method [1]
2308
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Timepoint [1]
2308
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Measured at 12 months.
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Eligibility
Key inclusion criteria
Metabolic Syndrome
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Minimum age
Not stated
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Type 2 Diabetes
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was performed using the First generator at www.randomisation.com. Subjects were randomised using method of randomly permuted blocks. Blocks of subjects were randomised with stratification for gender. This was achieved by generating separate randomisation lists for men and women.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Factorial
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
11/01/2005
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
160
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
184
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New Zealand
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State/province [1]
184
0
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Funding & Sponsors
Funding source category [1]
1062
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Government body
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Name [1]
1062
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Health Research Council
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Address [1]
1062
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Level 3, 110 Stanley Street, Auckland
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Country [1]
1062
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
PO BOX 913, 201 Great King Street Dunedin 9016
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Country
New Zealand
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Secondary sponsor category [1]
924
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None
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Name [1]
924
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Nil
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Address [1]
924
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Country [1]
924
0
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
36275
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Address
36275
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Country
36275
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Phone
36275
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Fax
36275
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Email
36275
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Contact person for public queries
Name
9588
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Patrick Manning
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Address
9588
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Department of Medicine
Dunedin Hospital
Dunedin
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Country
9588
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New Zealand
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Phone
9588
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+64 3 4740999
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Fax
9588
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Email
9588
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[email protected]
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Contact person for scientific queries
Name
516
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Patrick Manning
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Address
516
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Department of Medicine
Dunedin Hospital
Dunedin
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Country
516
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New Zealand
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Phone
516
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+64 3 4740999
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Fax
516
0
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Email
516
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[email protected]
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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.
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