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Magnesium in Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT01894867
Recruitment Status : Unknown
Verified June 2013 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 10, 2013
Last Update Posted : July 12, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
LIVER CIRRHOSIS Dietary Supplement: magnesium Dietary Supplement: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Magnesium Deficiency in Cirrhotic Patients
Study Start Date : August 2013
Estimated Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: magnesium
will get magnesium for 6 weeks
Dietary Supplement: magnesium
supply magnesium oxide for 6 weeks
Other Name: magnesium oxide

Placebo Comparator: placebo
will get placebo for 6 weeks
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. change in minimal hepatic encephalopathy [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. change in muscle weakness [ Time Frame: 6 weeks after intervention ]

Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01894867


Contacts
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Contact: keren cohen, MD 972522237442 kerenc03@walla.co.il
Contact: yona kitay, MD yonaki@clalit.org.il

Locations
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Israel
liver outpatients clinic, Meir medical center Not yet recruiting
Kfar Saba, Israel
Contact: keren cohen, MD    97297471560    keren.cohen@clalit.org.il   
Principal Investigator: keren cohen, MD         
Sub-Investigator: YONA KITAY, MD         
Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: keren cohen, MD Meir Medical Center

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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01894867     History of Changes
Other Study ID Numbers: MMC13247-12CTIL
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: July 12, 2013
Last Verified: June 2013
Keywords provided by Meir Medical Center:
LIVER CIRRHOSIS
MAGNESIUM
MINIMAL ENCEPHALOPATHY
MUSCLE WEAKNESS
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Magnesium Oxide
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents