Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-29 @ 12:22 AM
Study NCT ID:
NCT01894867
Status:
UNKNOWN
Last Update Posted:
2013-07-12
First Post:
2013-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium in Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008274', 'term': 'Magnesium'}, {'id': 'D008277', 'term': 'Magnesium Oxide'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'lastUpdateSubmitDate': '2013-07-11', 'studyFirstSubmitDate': '2013-07-04', 'studyFirstSubmitQcDate': '2013-07-09', 'lastUpdatePostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'chang in other cirrhosis parameters', 'timeFrame': '6 weeks after intervention', 'description': 'change in liver function test (AST ALT GPT GGT ALBUMIN INR) change in magnesium level'}], 'primaryOutcomes': [{'measure': 'change in minimal hepatic encephalopathy', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'change in muscle weakness', 'timeFrame': '6 weeks after intervention'}]}, 'conditionsModule': {'keywords': ['LIVER CIRRHOSIS', 'MAGNESIUM', 'MINIMAL ENCEPHALOPATHY', 'MUSCLE WEAKNESS'], 'conditions': ['LIVER CIRRHOSIS']}, 'descriptionModule': {'briefSummary': 'Several studies have shown in patients magnesium deficiency with liver cirrhosis.\n\nPatients with liver cirrhosis showed considerably reduced muscle strength and muscle magnesium.\n\nWe suggest addition of magnesium to patients with established cirrhosis in order to reduce the neuromuscular and neuropsychiatric manifestations of chronic liver disease.', 'detailedDescription': 'Magnesium is the fourth most abundant cation in the body and plays an important physiological role in many of its functions.\n\nThere are no readily available and easy methods to assess magnesium status but it is estimated that magnesium deficiency is a common problem.\n\nMagnesium 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.\n\nThere 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).\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with liver cirrhosis\n\nExclusion Criteria:\n\n* pregnant women\n* Patients with acute or chronic renal failure (cr\\>1.5)\n* Congestive heart failure NYHA 3-4\n* Patient with active cancer\n* Patients with dementia or mental retardation'}, 'identificationModule': {'nctId': 'NCT01894867', 'briefTitle': 'Magnesium in Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Magnesium Deficiency in Cirrhotic Patients', 'orgStudyIdInfo': {'id': 'MMC13247-12CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'magnesium', 'description': 'will get magnesium for 6 weeks', 'interventionNames': ['Dietary Supplement: magnesium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'will get placebo for 6 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'magnesium', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['magnesium oxide'], 'description': 'supply magnesium oxide for 6 weeks', 'armGroupLabels': ['magnesium']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'state': 'Israel', 'country': 'Israel', 'contacts': [{'name': 'keren cohen, MD', 'role': 'CONTACT', 'email': 'keren.cohen@clalit.org.il', 'phone': '97297471560'}, {'name': 'keren cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'YONA KITAY, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'liver outpatients clinic, Meir medical center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'keren cohen, MD', 'role': 'CONTACT', 'email': 'kerenc03@walla.co.il', 'phone': '972522237442'}, {'name': 'yona kitay, MD', 'role': 'CONTACT', 'email': 'yonaki@clalit.org.il'}], 'overallOfficials': [{'name': 'keren cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}