NCT01894867

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Last Updated

July 12, 2013

Status Verified

June 1, 2013

Enrollment Period

8 months

First QC Date

July 4, 2013

Last Update Submit

July 11, 2013

Conditions

LIVER CIRRHOSIS

Keywords

LIVER CIRRHOSISMAGNESIUMMINIMAL ENCEPHALOPATHYMUSCLE WEAKNESS

Outcome Measures

Primary Outcomes (1)

  • change in minimal hepatic encephalopathy

    6 weeks

Secondary Outcomes (1)

  • change in muscle weakness

    6 weeks after intervention

Other Outcomes (1)

  • chang in other cirrhosis parameters

    6 weeks after intervention

Study Arms (2)

magnesium

EXPERIMENTAL

will get magnesium for 6 weeks

Dietary Supplement: magnesium

placebo

PLACEBO COMPARATOR

will get placebo for 6 weeks

Dietary Supplement: Placebo

Interventions

magnesiumDIETARY_SUPPLEMENT

supply magnesium oxide for 6 weeks

Also known as: magnesium oxide
magnesium
PlaceboDIETARY_SUPPLEMENT
placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with liver cirrhosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

liver outpatients clinic, Meir medical center

Kfar Saba, Israel, Israel

Location

MeSH Terms

Conditions

Liver CirrhosisMuscle Weakness

Interventions

MagnesiumMagnesium Oxide

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetalsMagnesium CompoundsOxidesOxygen Compounds

Study Officials

  • keren cohen, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

keren cohen, MD

CONTACT

972522237442kerenc03@walla.co.il

yona kitay, MD

CONTACT

yonaki@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2013

First Posted

July 10, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Last Updated

July 12, 2013

Record last verified: 2013-06

Locations

IL(1)