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Magnesium in Liver Cirrhosis

Primary Purpose

LIVER CIRRHOSIS

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
magnesium
Placebo
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for LIVER CIRRHOSIS focused on measuring LIVER CIRRHOSIS, MAGNESIUM, MINIMAL ENCEPHALOPATHY, MUSCLE WEAKNESS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • liver outpatients clinic, Meir medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

magnesium

placebo

Arm Description

will get magnesium for 6 weeks

will get placebo for 6 weeks

Outcomes

Primary Outcome Measures

change in minimal hepatic encephalopathy

Secondary Outcome Measures

change in muscle weakness

Full Information

First Posted
July 4, 2013
Last Updated
July 11, 2013
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01894867
Brief Title
Magnesium in Liver Cirrhosis
Official Title
Magnesium Deficiency in Cirrhotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
LIVER CIRRHOSIS
Keywords
LIVER CIRRHOSIS, MAGNESIUM, MINIMAL ENCEPHALOPATHY, MUSCLE WEAKNESS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
magnesium
Arm Type
Experimental
Arm Description
will get magnesium for 6 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
will get placebo for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
magnesium
Other Intervention Name(s)
magnesium oxide
Intervention Description
supply magnesium oxide for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
change in minimal hepatic encephalopathy
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
change in muscle weakness
Time Frame
6 weeks after intervention
Other Pre-specified Outcome Measures:
Title
chang in other cirrhosis parameters
Description
change in liver function test (AST ALT GPT GGT ALBUMIN INR) change in magnesium level
Time Frame
6 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
keren cohen, MD
Phone
972522237442
Email
kerenc03@walla.co.il
First Name & Middle Initial & Last Name or Official Title & Degree
yona kitay, MD
Email
yonaki@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
keren cohen, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
liver outpatients clinic, Meir medical center
City
Kfar Saba
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
keren cohen, MD
Phone
97297471560
Email
keren.cohen@clalit.org.il
First Name & Middle Initial & Last Name & Degree
keren cohen, MD
First Name & Middle Initial & Last Name & Degree
YONA KITAY, MD

12. IPD Sharing Statement

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Magnesium in Liver Cirrhosis

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