A Phase 2/3 interventional study of Magnesium Sulfate and Pabrinex in Alcohol Withdrawal, Lactic Acidosis and Vitamin B1 Deficiency, sponsored by Glasgow Royal Infirmary. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Glasgow Royal Infirmary · Phase 2/3, Interventional, and Treatment
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.
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:
48 studies on the registry are indexed under Acidosis, Lactic; 5 are open to participants now.
This study's enrollment of 127 is above the median of 39 across 26 interventional studies indexed under Acidosis, Lactic.
Browse Acidosis, Lactic studies →Glasgow Royal Infirmary is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(Women of non-childbearing potential are defined as those defined as women who are or permanently sterilised (e.g. hysterectomy, tubal occlusion, bilateral salpingectomy).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pabrinex alone
Drug: Pabrinex
standard treatment and magnesium sulphate
Drug: Magnesium Sulfate · Drug: Pabrinex
This group receives the study intervention and delayed Pabrinex
Drug: Magnesium Sulfate
Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes
Also known as: MgSO4
standard treatment
Also known as: comercial form of thiamine and B vitamin preparation
Change in Erythrocyte transketolase activity
this is a biochemical marker of thiamine activity measured in units per gram of haemoglobin
Time frame: 0 and 2 hours
Change in serum lactate
Biochemical marker of metabolic dysfunction (expressed as mmol/L)
Time frame: 0 and 2 hours
Change in rate of resolution of alcohol withdrawal syndrome
time
Time frame: days
lactate dehydrogenase
biochemical (expressed in mmol/L)
Time frame: 0 and 2 hours
pre and post magnesium
biochemical (expressed in mmol/L)
Time frame: 0 and 2 hours
pre and post red cell thiamine
biochemical
Time frame: 0 and 2 hours
establish baseline micronutrient status of patients with alcohol withdrawal syndrome
biochemical
Time frame: o and 2 hours
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2016 to primary completion in Apr 2018, 15 months.
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Magnesium Sulfate
Glasgow Royal Infirmary