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

National Center for Research Resources (NCRR)

Status: Completed

Conditions: Alagille Syndrome; Cholestasis; Biliary Atresia

Treatments: Drug: magnesium gluconate; Drug: magnesium sulfate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00007033

CHMC-C-91-3-7

199/15488

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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