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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00007033
First Posted: December 7, 2000
Last Update Posted: January 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by:
National Center for Research Resources (NCRR)
December 6, 2000
December 7, 2000
January 22, 2009
October 2000
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Complete list of historical versions of study NCT00007033 on ClinicalTrials.gov Archive Site
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Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
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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.

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.

Interventional
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Primary Purpose: Treatment
  • Alagille Syndrome
  • Cholestasis
  • Biliary Atresia
  • Drug: magnesium gluconate
  • Drug: magnesium sulfate
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
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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
Sexes Eligible for Study: All
3 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00007033
199/15488
CHMC-C-91-3-7
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National Center for Research Resources (NCRR)
Children's Hospital Medical Center, Cincinnati
Study Chair: James Heubi Children's Hospital Medical Center, Cincinnati
National Center for Research Resources (NCRR)
April 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP