Magnesium in Liver Cirrhosis

July 11, 2013 updated by: Meir Medical Center

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

Unknown

Conditions

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Kfar Saba, Israel
        • liver outpatients clinic, Meir medical center
        • Contact:
        • Principal Investigator:
          • keren cohen, MD
        • Sub-Investigator:
          • YONA KITAY, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • magnesium oxide
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: keren cohen, MD, Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

April 1, 2014

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 12, 2013

Last Update Submitted That Met QC Criteria

July 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on LIVER CIRRHOSIS

Clinical Trials on Placebo

3
Subscribe