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Completed

NCT Number: NCT03466528

Alcohol: Thiamine and or Magnesium 1

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Magnesium sulfate

Drug

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

Other names: MgSO4

Pabrinex

Drug

standard treatment

Other names: comercial form of thiamine and B vitamin preparation

Primary outcomes

  1. 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

  2. Change in serum lactate

    Time frame: 0 and 2 hours

    Biochemical marker of metabolic dysfunction (expressed as mmol/L)

  3. Change in rate of resolution of alcohol withdrawal syndrome

    Time frame: days

    time

Secondary outcomes

  1. lactate dehydrogenase

    Time frame: 0 and 2 hours

    biochemical (expressed in mmol/L)

  2. pre and post magnesium

    Time frame: 0 and 2 hours

    biochemical (expressed in mmol/L)

  3. pre and post red cell thiamine

    Time frame: 0 and 2 hours

    biochemical

  4. establish baseline micronutrient status of patients with alcohol withdrawal syndrome

    Time frame: o and 2 hours

    biochemical

Sponsors and collaborators

Lead sponsor

Glasgow Royal Infirmary

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2018
Registry last updated
Jul 31, 2019

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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