- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01894867
Magnesium in Liver Cirrhosis
Magnesium Deficiency in Cirrhotic Patients
Several studies have shown in patients magnesium deficiency with liver cirrhosis.
Patients with liver cirrhosis showed considerably reduced muscle strength and muscle magnesium.
We suggest addition of magnesium to patients with established cirrhosis in order to reduce the neuromuscular and neuropsychiatric manifestations of chronic liver disease.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Magnesium is the fourth most abundant cation in the body and plays an important physiological role in many of its functions.
There are no readily available and easy methods to assess magnesium status but it is estimated that magnesium deficiency is a common problem.
Magnesium deficiency can cause a wide variety of features including hypocalcaemia, hypokalaemia and cardiac and neurological manifestations. Chronic low magnesium state has been associated with a number of chronic diseases including diabetes, hypertension, coronary heart disease, and osteoporosis.
There are not enough studies on magnesium status in chronic cirrhotics who may be in depletion. However , several studies have shown in patients magnesium deficiency with liver cirrhosis. Patients with liver cirrhosis showed considerably reduced muscle strength and muscle Mg . Magnesium may have a role in the neuromuscular and neuropsychiatric manifestations of chronic liver disease (hepatic encephalopathy and muscle cramps).
The use of magnesium as a therapeutic agent in asthma, myocardial infarction, and pre-eclampsia is also discussed. We suggest addition of magnesium to patients with established cirrhosis in order to reduce the neuromuscular and neuropsychiatric manifestations of chronic liver disease.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: keren cohen, MD
- Phone Number: 972522237442
- Email: kerenc03@walla.co.il
Study Contact Backup
- Name: yona kitay, MD
- Email: yonaki@clalit.org.il
Study Locations
-
-
-
Kfar Saba, Israel
- liver outpatients clinic, Meir medical center
-
Contact:
- keren cohen, MD
- Phone Number: 97297471560
- Email: keren.cohen@clalit.org.il
-
Principal Investigator:
- keren cohen, MD
-
Sub-Investigator:
- YONA KITAY, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with liver cirrhosis
Exclusion Criteria:
- pregnant women
- Patients with acute or chronic renal failure (cr>1.5)
- Congestive heart failure NYHA 3-4
- Patient with active cancer
- Patients with dementia or mental retardation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: magnesium
will get magnesium for 6 weeks
|
supply magnesium oxide for 6 weeks
Other Names:
|
Placebo Comparator: placebo
will get placebo for 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in minimal hepatic encephalopathy
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in muscle weakness
Time Frame: 6 weeks after intervention
|
6 weeks after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
chang in other cirrhosis parameters
Time Frame: 6 weeks after intervention
|
change in liver function test (AST ALT GPT GGT ALBUMIN INR) change in magnesium level
|
6 weeks after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: keren cohen, MD, Meir Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMC13247-12CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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