Magnesium in Liver Cirrhosis

LIVER CIRRHOSIS Clinical Trial

Official title:

Magnesium Deficiency in Cirrhotic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01894867
• Other study ID #: MMC13247-12CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 4, 2013
• Last updated: July 11, 2013
• Start date: August 2013

Study information

• Verified date: June 2013
• Source: Meir Medical Center
• Contact: keren cohen, MD
• Phone: 972522237442
• Email: kerenc03[@]walla.co.il
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• LIVER CIRRHOSIS

Intervention

Dietary Supplement:
• magnesium
supply magnesium oxide for 6 weeks
• Placebo

Locations

Country	Name	City	State
Israel	liver outpatients clinic, Meir medical center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	chang in other cirrhosis parameters	change in liver function test (AST ALT GPT GGT ALBUMIN INR) change in magnesium level	6 weeks after intervention	No
Primary	change in minimal hepatic encephalopathy		6 weeks	No
Secondary	change in muscle weakness		6 weeks after intervention	No