Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT00007033
Status:
COMPLETED
Last Update Posted:
2009-01-22
First Post:
2000-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016738', 'term': 'Alagille Syndrome'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001656', 'term': 'Biliary Atresia'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030691', 'term': 'gluconic acid'}, {'id': 'D008278', 'term': 'Magnesium Sulfate'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-04', 'lastUpdateSubmitDate': '2009-01-21', 'studyFirstSubmitDate': '2000-12-06', 'studyFirstSubmitQcDate': '2000-12-06', 'lastUpdatePostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-12-07', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Alagille syndrome', 'biliary atresia', 'cholestasis', 'gastrointestinal disorders', 'rare disease'], 'conditions': ['Alagille Syndrome', 'Cholestasis', 'Biliary Atresia']}, 'referencesModule': {'references': [{'pmid': '12183720', 'type': 'RESULT', 'citation': 'Heubi JE, Wiechmann DA, Creutzinger V, Setchell KD, Squires R Jr, Couser R, Rhodes P. Tauroursodeoxycholic acid (TUDCA) in the prevention of total parenteral nutrition-associated liver disease. J Pediatr. 2002 Aug;141(2):237-42. doi: 10.1067/mpd.2002.125802.'}]}, 'descriptionModule': {'briefSummary': 'OBJECTIVES:\n\nI. Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin D and reduced bone density in children with chronic cholestatic liver disease.', 'detailedDescription': 'PROTOCOL OUTLINE:\n\nPatients receive magnesium sulfate IV over 1 hour on day 3. Patients then receive oral magnesium gluconate supplementation daily. Treatment with magnesium sulfate repeats once at 3-6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "PROTOCOL ENTRY CRITERIA:\n\n--Disease Characteristics--\n\n* Diagnosis of liver disease with chronic cholestasis Nonsyndromic intrahepatic cholestasis Alagille's syndrome Extrahepatic biliary atresia\n* Direct bilirubin greater than 2 mg/dL OR Bile acids greater than 20 micromoles/L\n* No hepatic decompensation defined as one or more of the following: Ascites Peripheral edema PT at least 4 seconds longer than control Albumin less than 3 g/dL\n\n--Patient Characteristics--\n\n* Renal: No significant renal disease\n* Cardiovascular: No significant cardiovascular disease\n* Pulmonary: No significant pulmonary disease"}, 'identificationModule': {'nctId': 'NCT00007033', 'briefTitle': 'Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease', 'organization': {'class': 'NIH', 'fullName': 'National Center for Research Resources (NCRR)'}, 'orgStudyIdInfo': {'id': '199/15488'}, 'secondaryIdInfos': [{'id': 'CHMC-C-91-3-7'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'magnesium gluconate', 'type': 'DRUG'}, {'name': 'magnesium sulfate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Hospital Medical Center - Cincinnati", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'James Heubi', 'role': 'STUDY_CHAIR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, 'collaborators': [{'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}]}}}