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Trial record 16 of 22 for:    "Beriberi"

Alcohol: Thiamine and or Magnesium 1 (AToM1)

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ClinicalTrials.gov Identifier: NCT03466528
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Donogh Maguire, Glasgow Royal Infirmary

Brief 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.


Condition or disease Intervention/treatment Phase
Alcohol Withdrawal Lactic Acidosis Vitamin B1 Deficiency Magnesium Deficiency Wernicke Encephalopathy Drug: Magnesium Sulfate Drug: Pabrinex Phase 2 Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 16, 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Active Comparator: Standard treatment - Pabrinex alone
Pabrinex alone
Drug: Pabrinex
standard treatment
Other Name: comercial form of thiamine and B vitamin preparation

Active Comparator: Pabrinex + magnesium sulphate
standard treatment and magnesium sulphate
Drug: Magnesium Sulfate
Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes
Other Name: MgSO4

Drug: Pabrinex
standard treatment
Other Name: comercial form of thiamine and B vitamin preparation

Experimental: Magnesium sulphate alone
This group receives the study intervention and delayed Pabrinex
Drug: Magnesium Sulfate
Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes
Other Name: MgSO4




Primary Outcome Measures :
  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


Secondary Outcome Measures :
  1. Change in serum lactate [ Time Frame: 0 and 2 hours ]
    Biochemical marker of metabolic dysfunction (expressed as mmol/L)

  2. lactate dehydrogenase [ Time Frame: 0 and 2 hours ]
    biochemical (expressed in mmol/L)

  3. pre and post magnesium [ Time Frame: 0 and 2 hours ]
    biochemical (expressed in mmol/L)

  4. pre and post red cell thiamine [ Time Frame: 0 and 2 hours ]
    biochemical



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466528


Contacts
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Contact: Maureen Travers, MB BCh 0441412321813 Donogh.Maguire@gla.ac.uk
Contact: Maureen Travers, PhD 0441412321813 maureen.travers@ggc.scot.nhs.uk

Locations
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United Kingdom
Glasgow Royal Infirmary Recruiting
Glasgow, United Kingdom, G4 0SF
Contact: Donogh Maguire, MB BCh    0141 2115166    Donogh.Maguire@gla.ac.uk   
Contact: Alastair Ireland, Mb BCh    0141 2115166    Alastair.Ireland@ggc.scot.nhs.uk   
Sponsors and Collaborators
Glasgow Royal Infirmary
Investigators
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Principal Investigator: Donogh Maguire, MB BCh NHS GGC
  Study Documents (Full-Text)

Documents provided by Dr. Donogh Maguire, Glasgow Royal Infirmary:
Informed Consent Form  [PDF] September 21, 2016


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Responsible Party: Dr. Donogh Maguire, Emergency Medicine Consultant, Glasgow Royal Infirmary
ClinicalTrials.gov Identifier: NCT03466528     History of Changes
Other Study ID Numbers: GN16ME174
201773 ( Other Identifier: IRAS )
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Beriberi
Thiamine Deficiency
Brain Diseases
Acidosis
Acidosis, Lactic
Magnesium Deficiency
Wernicke Encephalopathy
Korsakoff Syndrome
Central Nervous System Diseases
Nervous System Diseases
Acid-Base Imbalance
Metabolic Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Brain Diseases, Metabolic
Vitamin B Deficiency
Avitaminosis
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Magnesium Sulfate
Thiamine
Analgesics
Sensory System Agents