Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006142
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-08-03
Brief Title:
Study of a Phenylalanine Restricted Diet During Pregnancy to Prevent Symptoms in Offspring of Patients With Phenylketonuria
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-08
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 Assess the impact of a phenylalanine restricted diet during pregnancy on symptoms in offspring of patients with phenylketonuria
I Assess the impact of a phenylalanine restricted diet during pregnancy on symptoms in offspring of patients with phenylketonuria
Detailed Description:
PROTOCOL OUTLINE This is a multicenter study
Patients receive a phenylalanine restricted diet based on a medical food such as Phenyl-free Lofenalac PKU 3 or Maximum XP may be supplemented with tyrosine as needed to achieve a target blood phenylalanine level of 2-6 mgdL The diet begins approximately 3 months prior to conception and continues until delivery of the baby Patients are evaluated once a month before conception and weekly during pregnancy Patients also undergo sonographic examination at 8 20 28 and 34 weeks gestation At birth the cord blood is evaluated for plasma amino acids If the baby is found to have an elevated phenylalanine level blood and urine are obtained to determine the babys genetic status Phenylalanine and tyrosine levels are checked in the baby daily for three days after birth
The baby is followed for physical and mental development at 3 and 6 months and then annually thereafter
Patients receive a phenylalanine restricted diet based on a medical food such as Phenyl-free Lofenalac PKU 3 or Maximum XP may be supplemented with tyrosine as needed to achieve a target blood phenylalanine level of 2-6 mgdL The diet begins approximately 3 months prior to conception and continues until delivery of the baby Patients are evaluated once a month before conception and weekly during pregnancy Patients also undergo sonographic examination at 8 20 28 and 34 weeks gestation At birth the cord blood is evaluated for plasma amino acids If the baby is found to have an elevated phenylalanine level blood and urine are obtained to determine the babys genetic status Phenylalanine and tyrosine levels are checked in the baby daily for three days after birth
The baby is followed for physical and mental development at 3 and 6 months and then annually thereafter
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 |
|---|---|---|---|
| UTMB-83-188 | None | None | None |