Study of Phosphatidylcholine in a Patient With Methionine Adenosyltransferase Deficiency - Tabular View

Tracking Information

First Received Date ^ICMJE

July 5, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

January 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00006061 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study of Phosphatidylcholine in a Patient With Methionine Adenosyltransferase Deficiency

Official Title ^ICMJE

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Methionine Adenosyltransferase Deficiency
Metabolism, Inborn Errors

Intervention ^ICMJE

Drug: phosphatidylcholine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2000

Primary Completion Date

Eligibility Criteria ^ICMJE

- Patient with methionine adenosyltransferase deficiency who is nursing

Gender

Female

Ages

20 Years to 20 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00006061

Responsible Party

Study ID Numbers ^ICMJE

199/15077, UNCCH-GCRC-1405

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

Information Provided By

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