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

National Center for Research Resources (NCRR)25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Alagille Syndrome Cholestasis Biliary Atresia

Interventions

magnesium gluconateDRUG

magnesium sulfateDRUG

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, United States

Data from ClinicalTrials.gov

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