Ignite Creation Date:
2024-05-06 @ 2:04 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01965691
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2013-10-16
Brief Title:
Protein Requirements in Children With Phenylketonuria PKU
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Application of Stable Isotopes to Determine Protein Requirements in Children With Phenylketonuria PKU
Status:
COMPLETED
Status Verified Date:
2020-09
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:
None
Brief Summary:
Phenylketonuria PKU is an inherited inborn error of an amino acid phenylalanine PHE metabolism affecting 115000 births It is caused by a decreased activity of an enzyme in the liver called phenylalanine hydroxylase PAH which is important to convert PHE into tyrosine another amino acid Consequently PHE accumulates in the blood leading to mental and developmental delays Nutritional management is the primary choice of treatment that includes providing sufficient protein in the diet and at the same time restricting PHE However the amount of protein to be given is unknown A new technique called Indicator Amino Acid Oxidation IAAO will be used to determine the protein requirements in children with PKU 5-18y The study will help treat and manage these children with sufficient protein to ensure proper growth and development Current dietary recommendations range from 35-65 gday and is based on factorial calculations
The investigators hypothesize that the protein requirement in children with PKU will be higher than the current mathematically calculated recommended intake of 35-65 gday for the 5-18y children
The investigators hypothesize that the protein requirement in children with PKU will be higher than the current mathematically calculated recommended intake of 35-65 gday for the 5-18y children
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None