NCT03466528

Alcohol: Thiamine and or Magnesium 1

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Glasgow Royal Infirmary · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Alcohol Withdrawal
• Lactic Acidosis
• Vitamin B1 Deficiency
• Magnesium Deficiency
• Wernicke Encephalopathy

Interventions

Type	Name	Description
DRUG	Magnesium Sulfate	Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes
DRUG	Pabrinex	standard treatment

Timeline

• Start date: 2016-12-16
• Primary completion: 2018-04-02
• Completion: 2018-06-19
• First posted: 2018-03-15
• Last updated: 2019-07-31

Locations

1 site across 1 country: United Kingdom