Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000661077
Ethics application status
Approved
Date submitted
9/08/2010
Date registered
13/08/2010
Date last updated
13/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Measurement and evaluation of thiamine concentrations in the blood of Australians who have a history of Diagnostic and Statistical Manual Fourth Edition(DSM IV) alcohol dependence or abuse, after 20 years of supplementing flour with thiamine.
Scientific title
Among Australians who have Diagnostic and Statistical Manual Fourth Edition(DSM IV) alcohol dependence or alcohol abuse, has thiamine supplementation of flour resulted in higher median serum thiamine concentrations than the normal population median reference range thus achieving the planned outcome of reducing the risk of Wernicke-Korsakoff syndrome in Australians.
Secondary ID [1] 252401 0
Royal Adelaide Hospital Protocol No :100511
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wernicke-Korsakoff syndrome 257913 0
Alcohol Dependence 257914 0
Thiamine Deficiency 257915 0
Alcohol Abuse 257937 0
Condition category
Condition code
Neurological 258080 258080 0 0
Dementias
Mental Health 258081 258081 0 0
Addiction
Public Health 258082 258082 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A sample of blood taken from each participant ,who presents over a two month period, at a driver assessment clinic will be tested using isocratic high performance liquid chromatography with Chromsystems reagents and protocol to measure the serum thiamine diphosphate
Intervention code [1] 256970 0
Not applicable
Comparator / control treatment
Thiamine pryrophosphate in whole blood normal reference range 66.5 -200 nmol/l, Source :F.E Krapf, W.P.Bieger, F.W. Tiller, Labordaten-Buch, Verlag Urban & Schwarzenberg, Munchen, 1995, p361
Control group
Historical

Outcomes
Primary outcome [1] 258943 0
Median serum thiamine phyrophosphate of the population with alcohol dependence and alcohol abuse
Timepoint [1] 258943 0
Data collected over a 2 month time period
Secondary outcome [1] 265111 0
Median serum Magnesium levels of the population with alcohol dependence and alcohol abuse
Timepoint [1] 265111 0
Data collected over a 2 month time period

Eligibility
Key inclusion criteria
Selection Criteria
1.Require assessment for DSM IV Alcohol Dependence by the Driver Assessment Clinic of Drug and Alcohol Services South Australia as a result of multiple driving under the influence of alcohol convictions
2.Able to provide a valid consent to participate in the study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Those who have had the surgical procedures: gastrectomy, gastrojejunostomy, partial or total colectomy, gastric bypasses surgery, vertical banded gastroplastyor obesity therapy with an intragastric balloon.
2.Patients who have had recurrent vomiting or chronic diarrhoea resulting from anorexia nervosa, pancreatitis and hyperemnesis gravidarum.
3.Those who have had the following cancer and related conditions: gastric or colon carcinoma, non Hodgkin’s lymphoma, myelomonocitic leukaemia, large B cell lymphoma, myeloid leukaemia, allogenic bone marrow transplantation, acquired immune deficiency syndrome.
4.Those who have renal disease requiring dialysis.
5.Magnesium depletion can result from chronic diuretic therapy, intestinal tract resection and Crohn’s disease. Patients with these conditions would be excluded from this aspect of the study

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257424 0
Self funded/Unfunded
Name [1] 257424 0
Country [1] 257424 0
Australia
Primary sponsor type
Individual
Name
Dr Philip Crowley, M.B.B.S., F.R.A.C.G.P., Grad. Dip. Mgt., Trainee R.A.C.P. Chapter of Addiction Medicine, Senior Medical Officer, Drug and Alcohol Services South Australia
Address
Community Based Treatment Interventions, Drug and Alcohol Services South Australia, based at The Warinilla Clinic, 92 Osmond Terrace, Norwood SA 5067
Country
Australia
Secondary sponsor category [1] 256657 0
Individual
Name [1] 256657 0
Dr Matt Gaughwin, Ph.D., M.B.B.S., F.A.F.P.H.M., F.A.Ch.A.M., Director Drug and Alcohol Resource Unit, Royal Adelaide Hospital
Address [1] 256657 0
Royal Adelaide Hospital
North Tce
Adelaide
SA 5000;
Country [1] 256657 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259445 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 259445 0
Royal Adelaide Hospital
North Tce
Adelaide
SA 5000
Ethics committee country [1] 259445 0
Australia
Date submitted for ethics approval [1] 259445 0
15/05/2010
Approval date [1] 259445 0
28/05/2010
Ethics approval number [1] 259445 0
100501

Summary
Brief summary
The primary aim of the study is to determine the concentrations of thiamine in blood taken from a sample of Australians who have had alcohol related motor vehicle offences. These measurements will allow an estimation of the prevalence of thiamine deficiency in this sample. Given flour has been supplemented with thiamine in Australia for twenty years a secondary aim is to evaluate whether this public health intervention has prevented thiamine deficiency in the main target group (chronic alcohol misusing persons).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31494 0
Address 31494 0
Country 31494 0
Phone 31494 0
Fax 31494 0
Email 31494 0
Contact person for public queries
Name 14741 0
Dr Philip Crowley
Address 14741 0
Community Based Treatment Interventions, Drug and Alcohol Services South Australia, based at The Warinilla Clinic, 92 Osmond Terrace, Norwood SA 5067
Country 14741 0
Australia
Phone 14741 0
61 8 8130 7500
Fax 14741 0
61 8 8130 7575
Email 14741 0
[email protected]
Contact person for scientific queries
Name 5669 0
Dr Philip Crowley
Address 5669 0
Community Based Treatment Interventions, Drug and Alcohol Services South Australia, based at The Warinilla Clinic, 92 Osmond Terrace, Norwood SA 5067
Country 5669 0
Australia
Phone 5669 0
61 8 8130 7500
Fax 5669 0
61 8 8130 7575
Email 5669 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
No additional documents have been identified.