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Alcohol: Thiamine and or Magnesium 1 (AToM1)

Primary Purpose

Alcohol Withdrawal, Lactic Acidosis, Vitamin B1 Deficiency

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Magnesium Sulfate
Pabrinex
Sponsored by
Glasgow Royal Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Withdrawal

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Glasgow Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Standard treatment - Pabrinex alone

Pabrinex + magnesium sulphate

Magnesium sulphate alone

Arm Description

Pabrinex alone

standard treatment and magnesium sulphate

This group receives the study intervention and delayed Pabrinex

Outcomes

Primary Outcome Measures

Change in Erythrocyte transketolase activity
this is a biochemical marker of thiamine activity measured in units per gram of haemoglobin
Change in serum lactate
Biochemical marker of metabolic dysfunction (expressed as mmol/L)
Change in rate of resolution of alcohol withdrawal syndrome
time

Secondary Outcome Measures

lactate dehydrogenase
biochemical (expressed in mmol/L)
pre and post magnesium
biochemical (expressed in mmol/L)
pre and post red cell thiamine
biochemical
establish baseline micronutrient status of patients with alcohol withdrawal syndrome
biochemical

Full Information

First Posted
February 13, 2018
Last Updated
July 29, 2019
Sponsor
Glasgow Royal Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT03466528
Brief Title
Alcohol: Thiamine and or Magnesium 1
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 16, 2016 (Actual)
Primary Completion Date
April 2, 2018 (Actual)
Study Completion Date
June 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glasgow Royal Infirmary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Withdrawal, Lactic Acidosis, Vitamin B1 Deficiency, Magnesium Deficiency, Wernicke Encephalopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment - Pabrinex alone
Arm Type
Active Comparator
Arm Description
Pabrinex alone
Arm Title
Pabrinex + magnesium sulphate
Arm Type
Active Comparator
Arm Description
standard treatment and magnesium sulphate
Arm Title
Magnesium sulphate alone
Arm Type
Experimental
Arm Description
This group receives the study intervention and delayed Pabrinex
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
MgSO4
Intervention Description
Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes
Intervention Type
Drug
Intervention Name(s)
Pabrinex
Other Intervention Name(s)
comercial form of thiamine and B vitamin preparation
Intervention Description
standard treatment
Primary Outcome Measure Information:
Title
Change in Erythrocyte transketolase activity
Description
this is a biochemical marker of thiamine activity measured in units per gram of haemoglobin
Time Frame
0 and 2 hours
Title
Change in serum lactate
Description
Biochemical marker of metabolic dysfunction (expressed as mmol/L)
Time Frame
0 and 2 hours
Title
Change in rate of resolution of alcohol withdrawal syndrome
Description
time
Time Frame
days
Secondary Outcome Measure Information:
Title
lactate dehydrogenase
Description
biochemical (expressed in mmol/L)
Time Frame
0 and 2 hours
Title
pre and post magnesium
Description
biochemical (expressed in mmol/L)
Time Frame
0 and 2 hours
Title
pre and post red cell thiamine
Description
biochemical
Time Frame
0 and 2 hours
Title
establish baseline micronutrient status of patients with alcohol withdrawal syndrome
Description
biochemical
Time Frame
o and 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donogh Maguire, MB BCh
Organizational Affiliation
NHS GGC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35484175
Citation
Maguire D, Burns A, Talwar D, Catchpole A, Stefanowicz F, Ross DP, Galloway P, Ireland A, Robson G, Adamson M, Orr L, Kerr JL, Roussis X, Colgan E, Forrest E, Young D, McMillan DC. Randomised trial of intravenous thiamine and/or magnesium sulphate administration on erythrocyte transketolase activity, lactate concentrations and alcohol withdrawal scores. Sci Rep. 2022 Apr 28;12(1):6941. doi: 10.1038/s41598-022-10970-x.
Results Reference
derived

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Alcohol: Thiamine and or Magnesium 1

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