Viewing Study NCT03939052



Ignite Creation Date: 2024-05-06 @ 1:06 PM
Last Modification Date: 2024-10-26 @ 1:09 PM
Study NCT ID: NCT03939052
Status: COMPLETED
Last Update Posted: 2019-08-22
First Post: 2019-05-01

Brief Title: Protein Requirements in Adults With Phenylketonuria PKU
Sponsor: University of British Columbia
Organization: University of British Columbia

Study Overview

Official Title: Protein Requirements in Phenylketonuria PKU Patients Compared Using PKU Sphere Glycomacropeptide GMP and an L-amino Acid-based Product
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: RECRUITING
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 phenylalanine PHE metabolism caused by decreased activity of phenylalanine hydroxylase PAH enzyme Therefore PHE accumulates in plasma leading to mental problems Treatment is a phenylalanine-restricted diet with sufficient protein However the optimum protein requirements are still unknown and compliance with diet is not satisfactory in PKU adults A Previously established technique called indicator amino acid oxidation IAAO will be used to determine protein requirements from amino acid based formula vs glycomacropeptide GMP in adults with PKU 19y This study will help treat adults with enough protein ensuring maintenance of health
Detailed Description: None

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