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Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease



Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease

For Condition: Cholestasis,Alagille Syndrome,Biliary Atresia
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Children's Hospital Medical Center - Cincinnati
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/18 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 25

Location and Contact Information:

Overall Study Official:
JamesHeubi,  Study Chair,  Children's Hospital Medical Center - Cincinnati

Children's Hospital Medical Center - Cincinnati
Cincinnati,  Ohio,  45229-3039
United States
 


Additional Information:
Study ID Numbers:
  199/15488;  CHMC-C-91-3-7
Study Start Date: October 2000
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007033

Other Biliary Atresia Studies:
1. Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease

2. Positional Cloning of the Gene(s) Responsible for Alagille Syndrome

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