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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:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00007033
First received: December 6, 2000
Last updated: January 21, 2009
Last verified: April 2002
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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
cholestasis
gastrointestinal disorders
rare disease

Additional relevant MeSH terms:
Biliary Atresia
Cholestasis
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on May 21, 2013