Trial Review

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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
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
Secondary ID [1] 262396 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The Metabolic Syndrome 896 0
Condition category
Condition code
Metabolic and Endocrine 964 964 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vitamin E/Lipoic acid for 12 months
Intervention code [1] 399 0
Treatment: Drugs
Comparator / control treatment
Placebo for 12 months.
Control group
Placebo

Outcomes
Primary outcome [1] 1278 0
Markers of Insulin Resistance
Timepoint [1] 1278 0
Assessed at the conclusion of study at 12 months.
Primary outcome [2] 1279 0
Reversal of the Metabolic Syndrome
Timepoint [2] 1279 0
Assessed at the conclusion of study at 12 months.
Secondary outcome [1] 2308 0
Inflammatory markers
Timepoint [1] 2308 0
Measured at 12 months.

Eligibility
Key inclusion criteria
Metabolic Syndrome
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 2 Diabetes

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)
Numbered containers.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 184 0
New Zealand
State/province [1] 184 0

Funding & Sponsors
Funding source category [1] 1062 0
Government body
Name [1] 1062 0
Health Research Council
Country [1] 1062 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO BOX 913, 201 Great King Street Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 924 0
None
Name [1] 924 0
Nil
Address [1] 924 0
Country [1] 924 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36275 0
Address 36275 0
Country 36275 0
Phone 36275 0
Fax 36275 0
Email 36275 0
Contact person for public queries
Name 9588 0
Patrick Manning
Address 9588 0
Department of Medicine
Dunedin Hospital
Dunedin
Country 9588 0
New Zealand
Phone 9588 0
+64 3 4740999
Fax 9588 0
Email 9588 0
PatrickManning@healthotago.co.nz
Contact person for scientific queries
Name 516 0
Patrick Manning
Address 516 0
Department of Medicine
Dunedin Hospital
Dunedin
Country 516 0
New Zealand
Phone 516 0
+64 3 4740999
Fax 516 0
Email 516 0
PatrickManning@healthotago.co.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.