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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)
  Purpose

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.


Condition Intervention
Alagille Syndrome Cholestasis 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:

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

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00007033


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

Publications:
ClinicalTrials.gov Identifier: NCT00007033     History of Changes
Other Study ID Numbers: 199/15488
CHMC-C-91-3-7
First Submitted: December 6, 2000
First Posted: December 7, 2000
Last Update Posted: January 22, 2009
Last Verified: April 2002

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

Additional relevant MeSH terms:
Alagille Syndrome
Cholestasis
Biliary Atresia
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents