Glasgow Royal Infirmary
Glasgow, G4 0SF, United Kingdom
NCT Number: NCT03466528
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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Notify Me18 year–100 year
All sexes
Interventional
Phase 2 / Phase 3
Glasgow, G4 0SF, United Kingdom
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(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).
Exclusion criteria
Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes
Other names: MgSO4
standard treatment
Other names: comercial form of thiamine and B vitamin preparation
Time frame: 0 and 2 hours
this is a biochemical marker of thiamine activity measured in units per gram of haemoglobin
Time frame: 0 and 2 hours
Biochemical marker of metabolic dysfunction (expressed as mmol/L)
Time frame: days
time
Time frame: 0 and 2 hours
biochemical (expressed in mmol/L)
Time frame: 0 and 2 hours
biochemical (expressed in mmol/L)
Time frame: 0 and 2 hours
biochemical
Time frame: o and 2 hours
biochemical
Glasgow Royal Infirmary
Other
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
Acronym: AToM1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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