Back to resultsStudy of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
Primary Purpose
Alagille Syndrome, Cholestasis, Biliary Atresia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
magnesium gluconate
magnesium sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Alagille Syndrome focused on measuring Alagille syndrome, biliary atresia, cholestasis, gastrointestinal disorders, rare disease
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of liver disease with chronic cholestasis Nonsyndromic intrahepatic cholestasis Alagille's syndrome Extrahepatic biliary atresia Direct bilirubin greater than 2 mg/dL OR Bile acids greater than 20 micromoles/L 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 --Patient Characteristics-- Renal: No significant renal disease Cardiovascular: No significant cardiovascular disease Pulmonary: No significant pulmonary disease
Sites / Locations
- Children's Hospital Medical Center - Cincinnati
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00007033
First Posted
December 6, 2000
Last Updated
January 21, 2009
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT00007033
Brief Title
Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2002
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Children's Hospital Medical Center, Cincinnati
4. Oversight
5. Study Description
Brief Summary
OBJECTIVES:
I. 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.
Detailed Description
PROTOCOL OUTLINE:
Patients 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alagille Syndrome, Cholestasis, Biliary Atresia
Keywords
Alagille syndrome, biliary atresia, cholestasis, gastrointestinal disorders, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
magnesium gluconate
Intervention Type
Drug
Intervention Name(s)
magnesium sulfate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of liver disease with chronic cholestasis Nonsyndromic intrahepatic cholestasis Alagille's syndrome Extrahepatic biliary atresia
Direct bilirubin greater than 2 mg/dL OR Bile acids greater than 20 micromoles/L
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
--Patient Characteristics--
Renal: No significant renal disease
Cardiovascular: No significant cardiovascular disease
Pulmonary: No significant pulmonary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Heubi
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital Medical Center - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12183720
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.
Results Reference
result
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Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
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