drugset / Trial / NCT02788552

Optimum Thiamine Intervention (OpTIn) Trial

NCT02788552

Phase 4 Completed 334 enrolled Menzies School of Health Research
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Thiamine Other / unclassified 100 mg Intravenous
Comparator Thiamine Other / unclassified 300 mg Intravenous
Comparator Thiamine Other / unclassified 900 mg Intravenous
Comparator Thiamine Other / unclassified 1500 mg Intravenous