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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00007033
Enrollment
25
Registered
2000-12-07
Start date
2000-10-31
Completion date
Unknown
Last updated
2009-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alagille Syndrome, Biliary Atresia, Cholestasis

Keywords

Alagille syndrome, biliary atresia, cholestasis, gastrointestinal disorders, rare disease

Brief summary

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.

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.

Interventions

DRUGmagnesium gluconate
DRUGmagnesium sulfate

Sponsors

Children's Hospital Medical Center, Cincinnati
CollaboratorOTHER
National Center for Research Resources (NCRR)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026