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Study of Phosphatidylcholine in a Patient With Methionine Adenosyltransferase Deficiency

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ClinicalTrials.gov Identifier: NCT00006061
Recruitment Status : Completed
First Posted : July 6, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
UNC Lineberger Comprehensive Cancer Center
Information provided by:
Office of Rare Diseases (ORD)

Tracking Information
First Submitted Date  ICMJE July 5, 2000
First Posted Date  ICMJE July 6, 2000
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE January 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Phosphatidylcholine in a Patient With Methionine Adenosyltransferase Deficiency
Official Title  ICMJE Not Provided
Brief Summary

OBJECTIVES: I. Determine whether plasma choline and breast milk choline levels are low at fasting in a patient with methionine adenosyltransferase deficiency, and if the choline levels are low, determine whether choline levels respond to dietary supplementation with phosphatidylcholine.

II. Determine whether this patient has a fatty liver by magnetic resonance spectroscopy.

Detailed Description

PROTOCOL OUTLINE:

Blood is drawn for liver function tests and measurement of plasma choline levels and breast milk samples are taken for measurement of breast milk choline levels at fasting and at 1 hour after breakfast on day 1. The patient then undergoes magnetic resonance spectroscopy of the liver to assess liver density and choline compound mass. The patient then receives oral phosphatidylcholine supplement, and plasma and breast milk samples are taken at 3 and 6 hours after the dose. Oral phosphatidylcholine supplements continue for 30 days. The above studies are repeated on day 31.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Methionine Adenosyltransferase Deficiency
  • Metabolism, Inborn Errors
Intervention  ICMJE Drug: phosphatidylcholine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
1
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2000
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE
  • Patient with methionine adenosyltransferase deficiency who is nursing
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 20 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00006061
Other Study ID Numbers  ICMJE 199/15077
UNCCH-GCRC-1405
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Center for Research Resources (NCRR)
Collaborators  ICMJE UNC Lineberger Comprehensive Cancer Center
Investigators  ICMJE
Study Chair: Steven H. Zeisel UNC Lineberger Comprehensive Cancer Center
PRS Account Office of Rare Diseases (ORD)
Verification Date July 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP