Study of Magnesium Sulfate in Children With Reduced Bone NCT00007033

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00007033
Other study ID #	199/15488
Secondary ID	CHMC-C-91-3-7
Status	Completed
Phase	N/A
First received	December 6, 2000
Last updated	January 21, 2009
Start date	October 2000

Study information
Verified date	April 2002
Source	National Center for Research Resources (NCRR)
Contact	n/a
Is FDA regulated	No
Health authority	United States: Federal Government
Study type	Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	25
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	3 Years to 18 Years
Eligibility	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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• magnesium gluconate

• magnesium sulfate

Locations
Country	Name	City	State
United States	Children's Hospital Medical Center - Cincinnati	Cincinnati	Ohio

Sponsors *(2)*
Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States,

References & Publications (1)

Heubi JE, Wiechmann DA, Creutzinger V, Setchell KD, Squires R Jr, Couser R, Rhodes P. Tauroursodeoxycholic acid (TUDCA) in the prevention of total parenteral nutrition-associated liver disease. J Pediatr. 2002 Aug;141(2):237-42. — View Citation

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

Clinical Trial Details — Status: Completed

Administrative data

Study information