Alcohol: Thiamine and or Magnesium 1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-16

Study Completion Date

2018-06-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alcohol Withdrawal Lactic Acidosis Vitamin B1 Deficiency Magnesium Deficiency Wernicke Encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard treatment - Pabrinex alone

Pabrinex alone

Group Type ACTIVE_COMPARATOR

Pabrinex

Intervention Type DRUG

standard treatment

Pabrinex + magnesium sulphate

standard treatment and magnesium sulphate

Group Type ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type DRUG

Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes

Pabrinex

Intervention Type DRUG

standard treatment

Magnesium sulphate alone

This group receives the study intervention and delayed Pabrinex

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes

Interventions

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Magnesium Sulfate

Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes

Intervention Type DRUG

Pabrinex

standard treatment

Intervention Type DRUG

Other Intervention Names

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MgSO4 comercial form of thiamine and B vitamin preparation

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No