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

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

This study has been completed.

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Children's Hospital Medical Center, Cincinnati
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00007033

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

Genetics Home Reference related topics:

Alagille syndrome

MedlinePlus related topics:

Liver Diseases

ChemIDplus related topics:

Magnesium Magnesium sulfate D-Gluconic acid, monosodium salt Gluconic acid Manganese gluconate Magnesium gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

Study ID Numbers:	199/15488, CHMC-C-91-3-7
First Received:	December 6, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00007033
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

Alagille syndrome

biliary atresia

cholestasis

gastrointestinal disorders

rare disease

Study placed in the following topic categories:

Liver Diseases

Cardiovascular Abnormalities

Alagille syndrome

Gastrointestinal Diseases

Cholestasis

Magnesium Sulfate

Rare Diseases

Biliary Atresia

Digestive System Diseases

Digestive System Abnormalities

Cholestasis, Intrahepatic

Genetic Diseases, Inborn

Bile Duct Diseases

Alagille Syndrome

Biliary Tract Diseases

Abnormalities, Multiple

Neoplasm Metastasis

Biliary atresia

Congenital Abnormalities

Heart Defects, Congenital

Additional relevant MeSH terms:

Disease

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Calcium Channel Blockers

Anesthetics

Central Nervous System Depressants

Reproductive Control Agents

Cardiovascular Agents

Pharmacologic Actions

Membrane Transport Modulators

Pathologic Processes

Tocolytic Agents

Sensory System Agents

Syndrome

Therapeutic Uses

Cardiovascular Diseases

Anti-Arrhythmia Agents

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Anticonvulsants

ClinicalTrials.gov processed this record on October 06, 2008