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Alcohol: Thiamine and or Magnesium 1

NCT03466528 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2019-07-31

No results posted yet for this study

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.

Conditions

  • Alcohol Withdrawal
  • Lactic Acidosis
  • Vitamin B1 Deficiency
  • Magnesium Deficiency
  • Wernicke Encephalopathy

Interventions

DRUG

Magnesium Sulfate

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

DRUG

Pabrinex

standard treatment

Sponsors & Collaborators

  • Glasgow Royal Infirmary

    lead OTHER

Principal Investigators

  • Donogh Maguire, MB BCh · NHS GGC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-16
Primary Completion
2018-04-02
Completion
2018-06-19

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03466528 on ClinicalTrials.gov