Alcohol: Thiamine and or Magnesium 1
Condition: Alcohol Withdrawal; Lactic Acidosis; Vitamin B1 Deficiency; Magnesium Deficiency; Wernicke Encephalopathy
MeSH terms: Brain Diseases; Wernicke Encephalopathy; Korsakoff Syndrome; Acidosis; Acidosis, Lactic; Magnesium Deficiency; Beriberi; Thiamine Deficiency
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Magnesium Sulfate; Pabrinex
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes; standard treatment
Other intervention name(s): MgSO4; comercial form of thiamine and B vitamin preparation
Intervention MeSH terms: Thiamine; Vitamin B Complex; Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model 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.
Masking: None (Open Label)
Primary purpose: Treatment