Study of Magnesium Sulfate in Children With Reduced Bone... | NCT00007033

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

NCT00007033

Sponsor

National Center for Research Resources (NCRR)

Status

Completed

Last Update Posted

Jan 22, 2009Estimated

Enrollment

Phase

Not Applicable

Conditions

Alagille Syndrome
Cholestasis
Biliary Atresia

Interventions

magnesium gluconate
magnesium sulfate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CHMC-C-91-3-7

Status Module

Record Verification Date

Apr 2002

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2000

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 6, 2000

First Submission Date that Met QC Criteria

Dec 6, 2000

First Posted Date

Dec 7, 2000Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2009

Last Update Posted Date

Jan 22, 2009Estimated

Name	Class
Children's Hospital Medical Center, Cincinnati	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Heubi	Children's Hospital Medical Center, Cincinnati	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Medical Center - Cincinnati		Cincinnati	Ohio	45229-3039	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12183720	Result	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.

ID	Term
D016738	Alagille Syndrome
D002779	Cholestasis
D001656	Biliary Atresia
D005767	Gastrointestinal Diseases
D035583	Rare Diseases

ID	Term
D002780	Cholestasis, Intrahepatic
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

ID	Term
C030691	gluconic acid
D008278	Magnesium Sulfate

ID	Term
D017616	Magnesium Compounds
D007287	Inorganic Chemicals
D013431	Sulfates
D013464	Sulfuric Acids

Name	Type	Description	Arm Group Labels	Other Names
magnesium gluconate	Drug
magnesium sulfate	Drug