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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02788552
Registration number
NCT02788552
Ethics application status
Date submitted
26/09/2014
Date registered
2/06/2016
Date last updated
16/08/2019
Titles & IDs
Public title
Optimum Thiamine Intervention (OpTIn) Trial
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Scientific title
Optimum Thiamine Intervention (OpT In) for Treatment and Prevention of Wernicke-Korsakoff Syndrome (WKS): A Randomised Controlled Trial
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Secondary ID [1]
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ACTRN12614000327684
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Secondary ID [2]
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2014-08-27_Version2.1
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Universal Trial Number (UTN)
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Trial acronym
OpTIn
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Wernicke-Korsakoff Syndrome
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Condition category
Condition code
Neurological
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Other neurological disorders
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Diet and Nutrition
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Other diet and nutrition disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Mental Health
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Other mental health disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Standardised Cognitive assessment - RUDAS
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Assessment method [1]
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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).
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Timepoint [1]
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Days 1 and 5 for Acute symptomatic patients and Days 1 and 3 for at risk patients
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Primary outcome [2]
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Standardised Cognitive assessment - CogState
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Assessment method [2]
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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.
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Timepoint [2]
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Days 1 and 5 for Acute symptomatic patients and Days 1 and 3 for at risk patients
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Primary outcome [3]
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Standardised Cognitive assessment - Story Memory Recall Test
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Assessment method [3]
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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
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Timepoint [3]
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Days 1 and 5 for Acute symptomatic patients and Days 1 and 3 for at risk patients
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Primary outcome [4]
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Standardised neurological examination
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Assessment method [4]
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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.
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Timepoint [4]
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Days 1 and 5 for acute symptomatic patients; Days 1 and 3 for at risk patients
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Secondary outcome [1]
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Blood thiamine levels
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Assessment method [1]
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Correlate changes in red cell thiamine test results (blood test) with cognitive (standardised cognitive assessments score) and neurological functioning (standardised neurological examination).
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Timepoint [1]
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Days 1 and 5 for acute symptomatic patients; days 1 and 3 for at risk patients
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Secondary outcome [2]
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Magnesium levels
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Assessment method [2]
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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).
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Timepoint [2]
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Days 1 and 5 for acute symptomatic patients; Days 1 and 3 for at risk patients
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Secondary outcome [3]
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Demographic factors
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Assessment method [3]
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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.
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Timepoint [3]
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Day 1
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Secondary outcome [4]
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Readmission
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Assessment method [4]
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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)
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Timepoint [4]
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Day 1
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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
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Minimum age
18
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2019
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Sample size
Target
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Accrual to date
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Final
334
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Recruitment in Australia
Recruitment state(s)
NT
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Recruitment hospital [1]
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Alice Springs Hospital - Alice Springs
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Recruitment postcode(s) [1]
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0810 - Alice Springs
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Funding & Sponsors
Primary sponsor type
Other
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Name
Menzies School of Health Research
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02788552
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kylie Dingwall, PhD
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Address
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Menzies School of Health Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02788552
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