Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006061
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-07-05
Brief Title:
Study of Phosphatidylcholine in a Patient With Methionine Adenosyltransferase Deficiency
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UNCCH-GCRC-1405 | None | None | None |