Magnesium in Liver Cirrhosis

NCT ID: NCT01894867

Last Updated: 2013-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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LIVER CIRRHOSIS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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magnesium

will get magnesium for 6 weeks

Group Type EXPERIMENTAL

magnesium

Intervention Type DIETARY_SUPPLEMENT

supply magnesium oxide for 6 weeks

placebo

will get placebo for 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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magnesium

supply magnesium oxide for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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magnesium oxide

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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keren cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

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liver outpatients clinic, Meir medical center

Kfar Saba, Israel, Israel

Site Status

Countries

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Israel

Central Contacts

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keren cohen, MD

Role: CONTACT

972522237442

yona kitay, MD

Role: CONTACT

Facility Contacts

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keren cohen, MD

Role: primary

97297471560

Other Identifiers

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MMC13247-12CTIL

Identifier Type: -

Identifier Source: org_study_id

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