- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03466528
Alcohol: Thiamine and or Magnesium 1 (AToM1)
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Glasgow, United Kingdom, G4 0SF
- Glasgow Royal Infirmary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
Active Comparator: Pabrinex + magnesium sulphate
standard treatment and magnesium sulphate
|
standard treatment
Other Names:
Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes
Other Names:
|
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:
|
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
Sponsor
Investigators
- Principal Investigator: Donogh Maguire, MB BCh, NHS GGC
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Alcohol-Related Disorders
- Substance-Related Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Nutrition Disorders
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Brain Diseases, Metabolic
- Vitamin B Deficiency
- Acid-Base Imbalance
- Memory Disorders
- Brain Diseases
- Acidosis
- Acidosis, Lactic
- Magnesium Deficiency
- Thiamine Deficiency
- Beriberi
- Wernicke Encephalopathy
- Korsakoff Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Micronutrients
- Membrane Transport Modulators
- Anticonvulsants
- Vitamins
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Vitamin B Complex
- Magnesium Sulfate
- Thiamine
Other Study ID Numbers
- GN16ME174
- 201773 (IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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