Ignite Creation Date:
2024-05-06 @ 1:38 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04086511
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2019-09-10
Brief Title:
PANDA PKU Amino Acid Evaluation
Sponsor:
Nutricia Research
Organization:
Nutricia Research
Study Overview
Official Title:
PANDA A Cross-sectional Study to Measure Blood Amino Acid Levels in PKU Children on a Protein Substitute
Status:
COMPLETED
Status Verified Date:
2021-09
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:
PANDA
Brief Summary:
Phenylketonuria PKU is a rare inherited metabolic disorder where subjects are born with a genetic deficiency in the phenylalanine hydroxylase enzyme PAH which leaves them unable to convert Phenylalanine Phe into Tyrosine Tyr PKU patients have specific dietary needs and must follow a restrictive diet in the aim of preventing toxic levels of the amino acid phenylalanine Phe accumulation
Detailed Description:
The exploratory studys main objective is to measure blood amino acid levels and to gain quantitative insights in children with PKU on a protein substitute with respect to evaluation of nutritional intake
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None