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Trial registered on ANZCTR


Trial ID
ACTRN12605000093684
Ethics application status
Approved
Date submitted
1/08/2005
Date registered
5/08/2005
Date last updated
5/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gamma-vitamin E study
Scientific title
Different forms of vitamin E and their effect on risk factors for heart disease in type 2 diabetic subjects. A randomised, double blind, placebo controlled trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk factors for heart disease in type 2 diabetics 174 0
Condition category
Condition code
Metabolic and Endocrine 195 195 0 0
Diabetes
Cardiovascular 196 196 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 week parallel intervention, volunteers randomised to either (i) RRR-alpha-tocopherol, (ii) mixed tocopherol (predominately gamma-tocopherol)?
Intervention code [1] 95 0
None
Comparator / control treatment
Placebo (soybean oil stripped of tocopherols)
Control group
Placebo

Outcomes
Primary outcome [1] 235 0
Inflammation
Timepoint [1] 235 0
At baseline and following the 6 week intervention
Primary outcome [2] 236 0
Oxidative stress (including neutrophil function)
Timepoint [2] 236 0
At baseline and following the 6 week intervention
Primary outcome [3] 237 0
Cellular enrichment
Timepoint [3] 237 0
At baseline and following the 6 week intervention
Secondary outcome [1] 534 0
Blood pressure
Timepoint [1] 534 0
At baseline and following 6 week intervention.
Secondary outcome [2] 535 0
Vascular function
Timepoint [2] 535 0
At baseline and following 6 week intervention.

Eligibility
Key inclusion criteria
Type 2 diabetes.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 diabetes, insulin use, pure vitamin E/tocopherol supplements, NSAIDs, smoking, recent CVD event, renal impairment, BMI>35, high alcohol intake.

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)
Randomisation done by someone not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects were randomised by block randomisation using computer generated random numbers, with no restrictions
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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 251 0
Government body
Name [1] 251 0
NHMRC
Address [1] 251 0
Country [1] 251 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 191 0
University
Name [1] 191 0
University of Western Australia
Address [1] 191 0
Country [1] 191 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36019 0
Address 36019 0
Country 36019 0
Phone 36019 0
Fax 36019 0
Email 36019 0
Contact person for public queries
Name 9284 0
Dr Natalie C. Ward
Address 9284 0
School of Medicine & Pharmacology
University of Western Australia
GPO Box X2213
Perth WA 6847
Country 9284 0
Australia
Phone 9284 0
+61 8 92240381
Fax 9284 0
+61 8 92240243
Email 9284 0
nward@cyllene.uwa.edu.au
Contact person for scientific queries
Name 212 0
A/Prof Kevin D. Croft
Address 212 0
School of Medicine & Pharmacology
University of Western Australia
GPO Box X2213
Perth WA 6847
Country 212 0
Australia
Phone 212 0
+61 8 92240275
Fax 212 0
+61 8 92240246
Email 212 0
kcroft@cyllene.uwa.edu.au