Diseases

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

Descriptive Information
Brief Title ^†	Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
Official Title ^†
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.
Study Phase	N/A
Study Type ^†	Interventional
Study Design ^†	Primary Purpose: Treatment
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Alagille Syndrome Cholestasis Biliary Atresia
Intervention ^†	Drugmagnesium gluconate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†	Drug
Estimated Enrollment ^†	25
Start Date ^†	October 2000
Completion Date
Primary Completion Date
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
Gender	Both
Ages	3 Years - 18 Years
Accepts Healthy Volunteers	No
Contacts ^††	, , , ,
Location Countries ^†	United States,
Administrative Information
NCT ID ^†	NCT00007033
Organization ID	199/15488
Secondary IDs ^††	CHMC-C-91-3-7
Responsible Party	,
Study Sponsor ^†	National Center for Research Resources (NCRR)
Collaborators ^††	Children's Hospital Medical Center, Cincinnati
Investigators ^†	Study Chair: James Heubi, Children's Hospital Medical Center, Cincinnati
Information Provided By	National Center for Research Resources (NCRR)
Verification Date	April 2002
First Received Date ^†	December 6, 2000
Last Updated Date	January 21, 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.