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

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. Identifier: NCT00007033
Recruitment Status : Completed
First Posted : December 7, 2000
Last Update Posted : January 22, 2009
Children's Hospital Medical Center, Cincinnati
Information provided by:
National Center for Research Resources (NCRR)

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Alagille Syndrome Cholestasis Biliary Atresia Drug: magnesium gluconate Drug: magnesium sulfate Not Applicable

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Primary Purpose: Treatment
Study Start Date : October 2000

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00007033

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United States, Ohio
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Children's Hospital Medical Center, Cincinnati
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Study Chair: James Heubi Children's Hospital Medical Center, Cincinnati

Publications of Results:
Layout table for additonal information Identifier: NCT00007033     History of Changes
Other Study ID Numbers: 199/15488
First Posted: December 7, 2000    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: April 2002

Keywords provided by National Center for Research Resources (NCRR):
Alagille syndrome
biliary atresia
gastrointestinal disorders
rare disease

Additional relevant MeSH terms:
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Biliary Atresia
Alagille Syndrome
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities
Cholestasis, Intrahepatic
Liver Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Abnormalities, Multiple
Genetic Diseases, Inborn
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents