A Phase 2/3 interventional study of Magnesium Sulfate and Pabrinex in Alcohol Withdrawal, Lactic Acidosis and Vitamin B1 Deficiency, sponsored by Glasgow Royal Infirmary. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Glasgow Royal Infirmary · Phase 2/3, Interventional, and Treatment
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.
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:
(Women of non-childbearing potential are defined as those defined as women who are post-menopausal or permanently sterilised (e.g. hysterectomy, tubal occlusion, bilateral salpingectomy).
Exclusion Criteria:
Pabrinex alone
Drug: Pabrinex
standard treatment and magnesium sulphate
Drug: Magnesium Sulfate · Drug: Pabrinex
This group receives the study intervention and delayed Pabrinex
Drug: Magnesium Sulfate
Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes
Also known as: MgSO4
standard treatment
Also known as: comercial form of thiamine and B vitamin preparation
Change in Erythrocyte transketolase activity
this is a biochemical marker of thiamine activity measured in units per gram of haemoglobin
Time frame: 0 and 2 hours
Change in serum lactate
Biochemical marker of metabolic dysfunction (expressed as mmol/L)
Time frame: 0 and 2 hours
Change in rate of resolution of alcohol withdrawal syndrome
time
Time frame: days
lactate dehydrogenase
biochemical (expressed in mmol/L)
Time frame: 0 and 2 hours
pre and post magnesium
biochemical (expressed in mmol/L)
Time frame: 0 and 2 hours
pre and post red cell thiamine
biochemical
Time frame: 0 and 2 hours
establish baseline micronutrient status of patients with alcohol withdrawal syndrome
biochemical
Time frame: o and 2 hours
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Glasgow Royal Infirmary