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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02788552




Registration number
NCT02788552
Ethics application status
Date submitted
26/09/2014
Date registered
2/06/2016

Titles & IDs
Public title
Optimum Thiamine Intervention (OpTIn) Trial
Scientific title
Optimum Thiamine Intervention (OpT In) for Treatment and Prevention of Wernicke-Korsakoff Syndrome (WKS): A Randomised Controlled Trial
Secondary ID [1] 0 0
ACTRN12614000327684
Secondary ID [2] 0 0
2014-08-27_Version2.1
Universal Trial Number (UTN)
Trial acronym
OpTIn
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wernicke-Korsakoff Syndrome 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Mental Health 0 0 0 0
Other mental health disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Thiamine Hydrochloride

Active comparator: Acute Symptomatic WKS- 300mg - Thiamine Hydrochloride 300mg daily (i.e. 100mg 3 times/day) for 5 days

Active comparator: Acute Symptomatic WKS - 900mg - Thiamine Hydrochloride 900mg daily (i.e. 300mg 3 times/day) for 5 days

Active comparator: Acute Symptomatic WKS - 1500mg - Thiamine Hydrochloride 1500mg daily (i.e. 500mg 3 times/day) for 5 days.

Active comparator: High-risk subclinical WKS- 100mg - Thiamine Hydrochloride 100mg once daily for 3 days.

Active comparator: High-risk subclinical WKS- 300mg - Thiamine Hydrochloride 300mg (i.e. 100mg 3 time/day) for 3 days

Active comparator: High-risk subclinical WKS - 900mg - Thiamine Hydrochloride 900mg daily (i.e. 300mg 3 times/day) for 3 days.


Treatment: Drugs: Thiamine Hydrochloride
Administered Intravenously in 100ml bag of normal saline (0.9%) infused over 30 mins.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Standardised Cognitive assessment - RUDAS
Timepoint [1] 0 0
Days 1 and 5 for Acute symptomatic patients and Days 1 and 3 for at risk patients
Primary outcome [2] 0 0
Standardised Cognitive assessment - CogState
Timepoint [2] 0 0
Days 1 and 5 for Acute symptomatic patients and Days 1 and 3 for at risk patients
Primary outcome [3] 0 0
Standardised Cognitive assessment - Story Memory Recall Test
Timepoint [3] 0 0
Days 1 and 5 for Acute symptomatic patients and Days 1 and 3 for at risk patients
Primary outcome [4] 0 0
Standardised neurological examination
Timepoint [4] 0 0
Days 1 and 5 for acute symptomatic patients; Days 1 and 3 for at risk patients
Secondary outcome [1] 0 0
Blood thiamine levels
Timepoint [1] 0 0
Days 1 and 5 for acute symptomatic patients; days 1 and 3 for at risk patients
Secondary outcome [2] 0 0
Magnesium levels
Timepoint [2] 0 0
Days 1 and 5 for acute symptomatic patients; Days 1 and 3 for at risk patients
Secondary outcome [3] 0 0
Demographic factors
Timepoint [3] 0 0
Day 1
Secondary outcome [4] 0 0
Readmission
Timepoint [4] 0 0
Day 1

Eligibility
Key inclusion criteria
* Aged range 18-65 years
* History of heavy alcohol use AUDIT-C score >4 or consumption >60mg/day or >80mg/binge
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant women
* Under the age of 18 or over 65 years old
* Known pre-existing neurological or cognitive impairment unrelated to thiamine deficiency or WKS
* Renal dialysis patients
* Sedated patients in ICU

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)
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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2019
Sample size
Target
Accrual to date
Final
334
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Alice Springs Hospital - Alice Springs
Recruitment postcode(s) [1] 0 0
0810 - Alice Springs

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Kylie Dingwall, PhD
Address 0 0
Menzies School of Health Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02788552