The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02788552
Ethics application status
Date submitted
26/09/2014
Date registered
2/06/2016
Date last updated
14/11/2017

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
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
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

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 - Evaluate differences in cognitive outcomes among acute symptomatic WKS patients under three parenteral thiamine treatment conditions (300mg/day for 5 days, versus 900mg/day for 5 days, versus 1500mg/day for 5 days); and among patients at high risk of subclinical WKS-related brain damage under three parenteral thiamine treatment conditions (100mg/day for 3 days, versus 300mg/day for 3 days, versus 900mg/day for 3 days); using Standardised cognitive assessment - Rowland Universal Dementia Assessment Scale (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 - Evaluate differences in cognitive outcomes among acute symptomatic WKS patients under three parenteral thiamine treatment conditions (300mg/day for 5 days, versus 900mg/day for 5 days, versus 1500mg/day for 5 days); and among patients at high risk of subclinical WKS-related brain damage under three parenteral thiamine treatment conditions (100mg/day for 3 days, versus 300mg/day for 3 days, versus 900mg/day for 3 days); using CogState battery.
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 - Evaluate differences in cognitive outcomes among acute symptomatic WKS patients under three parenteral thiamine treatment conditions (300mg/day for 5 days, versus 900mg/day for 5 days, versus 1500mg/day for 5 days); and among patients at high risk of subclinical WKS-related brain damage under three parenteral thiamine treatment conditions (100mg/day for 3 days, versus 300mg/day for 3 days, versus 900mg/day for 3 days); using 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 - Evaluate differences in neurological outcomes among acute symptomatic WKS patients under three parenteral thiamine treatment conditions (300mg/day for 5 days, versus 900mg/day for 5 days, versus 1500mg/day for 5 days);and among patients at high-risk of subclinical WKS-related brain damage under three parenteral thiamine treatment conditions (100mg/day for 3 days, versus 300mg/day for 3 days, versus 900mg/day for 3 days); Using Standardised neurological examination. Aggregated as either normal or abnormal.
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 - Correlate changes in red cell thiamine test results (blood test) with cognitive (standardised cognitive assessments score) and neurological functioning (standardised neurological examination).
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 - Examine the impact of magnesium deficiency (magnesium blood test) on thiamine treatment response (cognition as measured by standardised cognitive assessments and thiamine pyrophosphate levels as measured by blood test).
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 - Assess independent predictors of WKS including nutritional factors, substance use history and demographic factors assessed by questionnaire items including Nutritional Risk Assessment and AUDIT-C.
Timepoint [3] 0 0
Day 1
Secondary outcome [4] 0 0
Readmission - Examine the impact of patient re-admission on red cell thiamine pyrophosphate levels (blood test) and cognitive and neurological functioning (standardised cognitive and neurological assessments)
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
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
Wernicke-Korsakoff syndrome (WKS), once thought to be a rare condition, is now known to be
common in people with nutritional deficiencies or alcohol dependence. The primary cause of
WKS is thiamine deficiency, and more than 90% of cases are reported in alcohol dependent
patients because alcohol dependence predisposes to severe nutritional deficiency. WKS may
lead to significant, long-term brain dysfunction with severe effects on work, personal and
social function. Whilst effective treatment may greatly reduce severe disability and the
human and social costs of this illness, almost no evidence exists on optimal dosing regimens.
This project proposes to develop quality evidence for effective treatment of WKS in an
Aboriginal setting.
Trial website
https://clinicaltrials.gov/show/NCT02788552
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
Kylie Dingwall, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 8 89514753
Fax 0 0
Email 0 0
kylie.dingwall@menzies.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02788552