Study of Phosphatidylcholine in a Patient With Methionine Adenosyltransferase Deficiency

Metabolism, Inborn Errors Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006061
• Other study ID #: 199/15077
• Secondary ID: UNCCH-GCRC-1405
• Status: Completed
• Phase: N/A
• First received: July 5, 2000
• Last updated: June 23, 2005
• Start date: January 2000
• Est. completion date: January 2000

Study information

• Verified date: July 2000
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 2000
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 20 Years
• Eligibility: - Patient with methionine adenosyltransferase deficiency who is nursing

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amino Acid Metabolism, Inborn Errors
• Metabolism, Inborn Errors
• Methionine Adenosyltransferase Deficiency

Intervention

Drug:
• phosphatidylcholine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	UNC Lineberger Comprehensive Cancer Center