Alcohol: Thiamine and or Magnesium 1 (AToM1)

July 29, 2019 updated by: Dr. Donogh Maguire, Glasgow Royal Infirmary

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Glasgow, United Kingdom, G4 0SF
        • Glasgow Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard treatment - Pabrinex alone
Pabrinex alone
standard treatment
Other Names:
  • comercial form of thiamine and B vitamin preparation
Active Comparator: Pabrinex + magnesium sulphate
standard treatment and magnesium sulphate
standard treatment
Other Names:
  • comercial form of thiamine and B vitamin preparation
Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes
Other Names:
  • MgSO4
Experimental: Magnesium sulphate alone
This group receives the study intervention and delayed Pabrinex
Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes
Other Names:
  • MgSO4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Erythrocyte transketolase activity
Time Frame: 0 and 2 hours
this is a biochemical marker of thiamine activity measured in units per gram of haemoglobin
0 and 2 hours
Change in serum lactate
Time Frame: 0 and 2 hours
Biochemical marker of metabolic dysfunction (expressed as mmol/L)
0 and 2 hours
Change in rate of resolution of alcohol withdrawal syndrome
Time Frame: days
time
days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lactate dehydrogenase
Time Frame: 0 and 2 hours
biochemical (expressed in mmol/L)
0 and 2 hours
pre and post magnesium
Time Frame: 0 and 2 hours
biochemical (expressed in mmol/L)
0 and 2 hours
pre and post red cell thiamine
Time Frame: 0 and 2 hours
biochemical
0 and 2 hours
establish baseline micronutrient status of patients with alcohol withdrawal syndrome
Time Frame: o and 2 hours
biochemical
o and 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Donogh Maguire, MB BCh, NHS GGC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2016

Primary Completion (Actual)

April 2, 2018

Study Completion (Actual)

June 19, 2018

Study Registration Dates

First Submitted

February 13, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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