CompletedPhase 2/3

Alcohol: Thiamine and or Magnesium 1

United Kingdom127 participantsStarted 2016-12-16

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Change in Erythrocyte transketolase activity

Timeframe: 0 and 2 hours

Change in serum lactate

Timeframe: 0 and 2 hours

Change in rate of resolution of alcohol withdrawal syndrome

Timeframe: days

Trial details

NCT IDNCT03466528

SponsorGlasgow Royal Infirmary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04-02