NCT00007033

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2000

Completed
Last Updated

January 22, 2009

Status Verified

April 1, 2002

First QC Date

December 6, 2000

Last Update Submit

January 21, 2009

Conditions

Alagille SyndromeCholestasisBiliary Atresia

Keywords

Alagille syndromebiliary atresiacholestasisgastrointestinal disordersrare disease

Interventions

magnesium gluconateDRUG
magnesium sulfateDRUG

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

Location

Related 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. doi: 10.1067/mpd.2002.125802.

    PMID: 12183720RESULT

MeSH Terms

Conditions

Alagille SyndromeCholestasisBiliary AtresiaGastrointestinal DiseasesRare Diseases

Interventions

gluconic acidMagnesium Sulfate

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornDigestive System AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • James Heubi

    Children's Hospital Medical Center, Cincinnati

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

December 6, 2000

First Posted

December 7, 2000

Study Start

October 1, 2000

Last Updated

January 22, 2009

Record last verified: 2002-04

Locations

US(1)