drugset / Trial / NCT03466528

Alcohol: Thiamine and or Magnesium 1

NCT03466528 ↗

Phase 2/3 Completed 127 enrolled Glasgow Royal Infirmary
RandomizedParallel-groupOpen-labelTreatment

Summary

Patients who suffer Alcohol Use Disorder (AUD) have a 30-80% incidence of thiamine deficiency causing Wernicke's Encephalopathy (WE). Intravenous (IV) thiamine replacement is standard practice in the treatment of alcoholic patients presenting to the Accident \& Emergency (A\&E) department, however routine co-supplementation with magnesium (administered IV as magnesium sulphate ), which is required as a co-factor for thiamine in some metabolic processes, e. g. on the activity of the enzyme transketolase in red blood cells, is not routine practice in the treatment of these patients. Without correction of concomitant magnesium deficiency there may be impaired utilisation of thiamine resulting in a failure to treat WE. This study is designed to determine if administration of magnesium to AUD patients affects red cell transketolasae and serum lactate concentrations by itself, or only acts to increase the effect of thiamine on the activity of this enzyme.

Timeline

Start
2016-12-16
Primary completion
2018-04-02
Completion
2018-06-19

Outcome

Missed primary endpoint

paper No significant difference was found between groups for the primary endpoint of change in ETKA. PMID 35484175 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes Unknown 2 g Intravenous
Comparator Pabrinex Unknown — Intravenous