Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000051943
Ethics application status
Approved
Date submitted
2/02/2010
Date registered
14/01/2011
Date last updated
3/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The chronic effects of thiamin on cardiovascular risk factors in individuals with hyperglycaemia
Scientific title
thiamin supplementation in those with hyperglycaemia: impact on blood lipids, microalbuminaemia and endothelial dysfunction
Secondary ID [1] 253410 0
None
Universal Trial Number (UTN)
U1111-1113-4931
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hyperglycaemia 256690 0
dyslipidaemia 256691 0
microalbuminaemia 256692 0
reduction of cardiovascular disease risk factors in those with hyperglycaemia 260959 0
Condition category
Condition code
Cardiovascular 256847 256847 0 0
Coronary heart disease
Metabolic and Endocrine 259094 259094 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
100 mg thiamin taken as an oral capsule 3 times per day for 6 weeks in a crossover design which includes a wash-out of approximately 3 mo. After the 3 month wash-out, participants will move onto the placebo treatment and vice versa in the control group.
Intervention code [1] 255922 0
Treatment: Drugs
Comparator / control treatment
placebo is an identical capsule filled with lactose taken 3 times per day for a total of 6 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 257712 0
fasting blood glucose by blood analysis
Timepoint [1] 257712 0
baseline, 3 and 6 weeks
Primary outcome [2] 257713 0
blood lipids by blood analysis
Timepoint [2] 257713 0
baseline and 6 weeks
Primary outcome [3] 257714 0
urinary albumin by urinanalysis
Timepoint [3] 257714 0
baseline and 6 weeks
Primary outcome [4] 257716 0
fat oxidation during glucose load using gas analysis (medical equipment)
Timepoint [4] 257716 0
baseline, 3 and 6 weeks
Secondary outcome [1] 263064 0
thiamin status by blood analysis
Timepoint [1] 263064 0
baseline and 6 weeks
Secondary outcome [2] 263065 0
fasting blood pressure using medical equipment (a vital signs patient monitor)
Timepoint [2] 263065 0
baseline, 3 and 6 weeks

Eligibility
Key inclusion criteria
hyperglycaemic volunteers with body mass index (BMI) 19-40
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
smoking, known impaired renal or liver function, cardiovascular disease (CVD) event over the last 6 mo, more than 2 std drinks per day, systemic illnesses or use of medications, known allergy or intolerance to thiamin; use of all supplements containing thiamin; pregnancy or lactation

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)
block randomisation was conducted by a person with no contact with the subjects (allocation concelament). A number was allocated to the intervention and to the control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/05/2009
Actual
12/05/2009
Date of last participant enrolment
Anticipated
Actual
23/05/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
17
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256421 0
University
Name [1] 256421 0
Curtin University
Country [1] 256421 0
Australia
Primary sponsor type
Individual
Name
Jill Sherriff
Address
School of Public Health
Curtin University
GPO Box U1987
Perth 6845
Western Australia
Country
Australia
Secondary sponsor category [1] 255763 0
Individual
Name [1] 255763 0
Assoc Prof Mario Soares
Address [1] 255763 0
School of Public Health
Curtin University
GPO Box U1987
Perth 6845
Western Australia
Country [1] 255763 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258472 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 258472 0
R&D
GPO Box U1987
Perth 6845
Western Australia
Ethics committee country [1] 258472 0
Australia
Date submitted for ethics approval [1] 258472 0
Approval date [1] 258472 0
08/12/2008
Ethics approval number [1] 258472 0
161/2008

Summary
Brief summary
Thiamin or benfotiamine supplementation has been shown to have positive effects on CVD risk factors in animals with experimental diabetes and a few studies of humans with diabetes. This study is designed to see if thiamin has benefts in those with glucose intolerance.
Trial website
Trial related presentations / publications
High-dose thiamine supplementation improves glucose tolerance in hyperglycemic individuals: a randomized, double-blind cross-over trial.
Alaei Shahmiri F, Soares MJ, Zhao Y, Sherriff J.
Eur J Nutr. 2013 Oct;52(7):1821-4. doi: 10.1007/s00394-013-0534-6. Epub 2013 May 29.
Public notes

Contacts
Principal investigator
Name 30775 0
A/Prof Jill Sherriff
Address 30775 0
School of Public Health
Curtin University
GPO Box U1987
Perth 6845
WA
Country 30775 0
Australia
Phone 30775 0
+61 8 9266 7948
Fax 30775 0
Email 30775 0
[email protected]
Contact person for public queries
Name 14022 0
A/Prof Assoc Prof Jill Sherriff
Address 14022 0
School of Public Health
Curtin University
GPO Box U1987
Perth 6845
Western Australia
Country 14022 0
Australia
Phone 14022 0
+61 8 92667948
Fax 14022 0
+61 8 92662958
Email 14022 0
[email protected]
Contact person for scientific queries
Name 4950 0
A/Prof Assoc Prof Jill Sherriff
Address 4950 0
School of Public Health
Curtin University
GPO Box U1987
Perth 6845
Western Australia
Country 4950 0
Australia
Phone 4950 0
+61 8 92667948
Fax 4950 0
+61 8 92662958
Email 4950 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseHigh-dose thiamine supplementation may reduce resting energy expenditure in individuals with hyperglycemia: a randomized, double - blind cross-over trial.2020https://dx.doi.org/10.1007/s40200-020-00508-1
N.B. These documents automatically identified may not have been verified by the study sponsor.