Magnesium Citrate Solution |
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Clinical Trial: Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
This study has been completed.
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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 | Treatment or Intervention |
|---|---|
| Alagille Syndrome Cholestasis Biliary Atresia | Drug: magnesium gluconate Drug: magnesium sulfate |
MedlinePlus related topics: Bile Duct Diseases; Birth Defects; Digestive Diseases; Liver Diseases
Genetics Home Reference related topics: Alagille syndrome
Study Type: Interventional
Study Design: Treatment
Expected Total Enrollment: 25
Study start: October 2000
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 - 18 Years, Genders Eligible for Study: Both
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
Location Information
Ohio
Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, 45229-3039, United States
James Heubi, Study Chair, Children's Hospital Medical Center - Cincinnati
More Information
Record last reviewed: April 2002
Last Updated: October 13, 2004
Record first received: December 6, 2000
ClinicalTrials.gov Identifier: NCT00007033
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Magnesium Citrate Solution (Drug Digest)

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