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

This study has been completed.
Children's Hospital Medical Center, Cincinnati
Information provided by:
National Center for Research Resources (NCRR) Identifier:
First received: December 6, 2000
Last updated: January 21, 2009
Last verified: April 2002


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 Intervention
Alagille Syndrome
Biliary Atresia
Drug: magnesium gluconate
Drug: magnesium sulfate

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 25
Study Start Date: October 2000
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.


Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00007033

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
Study Chair: James Heubi Children's Hospital Medical Center, Cincinnati
  More Information

Publications: Identifier: NCT00007033     History of Changes
Other Study ID Numbers: 199/15488  CHMC-C-91-3-7 
Study First Received: December 6, 2000
Last Updated: January 21, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Alagille Syndrome
Biliary Atresia
Abnormalities, Multiple
Bile Duct Diseases
Biliary Tract Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Cholestasis, Intrahepatic
Congenital Abnormalities
Digestive System Abnormalities
Digestive System Diseases
Genetic Diseases, Inborn
Heart Defects, Congenital
Liver Diseases
Magnesium Sulfate
Anti-Arrhythmia Agents
Calcium Channel Blockers
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Tocolytic Agents processed this record on May 26, 2016