Alcohol: Thiamine and or Magnesium 1

Alcohol Withdrawal Clinical Trial

— AToM1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466528
• Other study ID #: GN16ME174
• Secondary ID: 201773
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 16, 2016
• Est. completion date: June 19, 2018

Study information

• Verified date: July 2019
• Source: Glasgow Royal Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: June 19, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• Male or non-pregnant or breastfeeding females =18 years of age For women of child-bearing potential a negative pregnancy test will be required prior to treatment.

(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).

• Chronic alcohol dependence as confirmed by

• FAST questionnaire

• GMAWS scale

Exclusion Criteria:

• Unable to give consent

• Less than 18 years of age

• Chronic renal or hepatic failure/hepatic encephalopathy (investigator assessment as documented in past medical history i.e. Clinical Portal.)

• Known hypersensitivity or previous allergy to any of the active substances in either trial medication, or to excipients

• Severe concurrent medical condition that would prevent participation in study procedures (e.g. myasthenia gravis, clinically significant cardiac disease, or cardiac failure with severe pulmonary oedema)

Related Conditions & MeSH terms

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

Intervention

Drug:
• Magnesium Sulfate
Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes
• Pabrinex
standard treatment

Locations

Country	Name	City	State
United Kingdom	Glasgow Royal Infirmary	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Glasgow Royal Infirmary

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Erythrocyte transketolase activity	this is a biochemical marker of thiamine activity measured in units per gram of haemoglobin	0 and 2 hours
Primary	Change in serum lactate	Biochemical marker of metabolic dysfunction (expressed as mmol/L)	0 and 2 hours
Primary	Change in rate of resolution of alcohol withdrawal syndrome	time	days
Secondary	lactate dehydrogenase	biochemical (expressed in mmol/L)	0 and 2 hours
Secondary	pre and post magnesium	biochemical (expressed in mmol/L)	0 and 2 hours
Secondary	pre and post red cell thiamine	biochemical	0 and 2 hours
Secondary	establish baseline micronutrient status of patients with alcohol withdrawal syndrome	biochemical	o and 2 hours