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Optimum Thiamine Intervention (OpTIn) Trial

NCT02788552 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2019-08-16

No results posted yet for this study

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.

Conditions

  • Wernicke-Korsakoff Syndrome

Interventions

DRUG

Thiamine Hydrochloride

Administered Intravenously in 100ml bag of normal saline (0.9%) infused over 30 mins.

Sponsors & Collaborators

  • Menzies School of Health Research

    lead OTHER

Principal Investigators

  • Kylie Dingwall, PhD · Menzies School of Health Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2019-05-30
Completion
2019-08-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02788552 on ClinicalTrials.gov