Alcohol: Thiamine and or Magnesium 1 — AToM1  

Alcohol Withdrawal Clinical Trial

Official title: A Prospective Randomised Controlled Trial of the Effect of Magnesium Sulphate Administration on Red Cell Transketolase Activity in Alcohol Dependent Patients at Risk of Wernicke Korsakoff Syndrome Treated With Thiamine

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a 3- arm randomised, open label, controlled study in a cohort of alcoholic patients admitted through A&E. Patients will be randomised to concurrent infusion of one of the following:

• Arm 1: IV thiamine

• Arm 2: IV magnesium sulphate followed by delayed IV thiamine

• Arm 3: IV thiamine and IV magnesium sulphate Thiamine will be administered as IV Pabrinex, a compound preparation which also contains B vitamins and vitamin C. Administration of IV Pabrinex is standard care in this patient group and magnesium sulphate is routinely co-administered at Glasgow Royal Infirmary. ;

Related Conditions & MeSH terms

• Acidosis
• Acidosis, Lactic
• Alcohol Withdrawal
• Beriberi
• Brain Diseases
• Lactic Acidosis
• Magnesium Deficiency
• Thiamine Deficiency
• Vitamin B1 Deficiency
• Wernicke Encephalopathy

• NCT number: NCT03466528
• Study type: Interventional
• Source: Glasgow Royal Infirmary
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 16, 2016
• Completion date: June 19, 2018