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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00007033
• Date of registration: 06/12/2000
• Prospective Registration: No
• Primary sponsor: National Center for Research Resources (NCRR)
• Public title: Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
• Date of first enrolment: October 2000
• Target sample size: 25
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00007033
• Study type: Interventional
• Study design: Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: James Heubi
• Affiliation: Children's Hospital Medical Center, Cincinnati

Key inclusion & 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



Age minimum: 3 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cholestasis

Alagille Syndrome

Biliary Atresia

Intervention(s)

Drug: magnesium gluconate

Drug: magnesium sulfate

Secondary ID(s)

199/15488

CHMC-C-91-3-7

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Children's Hospital Medical Center, Cincinnati