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CompletedNCT04086511

PANDA: PKU Amino Acid Evaluation

PANDA: A Cross-sectional Study to Measure Blood Amino Acid Levels in PKU Children on a Protein Substitute

Status
Completed
Phase
Study type
Observational
Enrollment
37 (actual)
Sponsor
Nutricia Research · Industry
Sex
All
Age
2 Years – 12 Years
Healthy volunteers

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 study's 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.

Conditions

Timeline

Start date
2019-09-10
Primary completion
2022-12-21
Completion
2023-04-14
First posted
2019-09-11
Last updated
2023-06-02

Locations

2 sites across 2 countries: Belgium, United Kingdom

Source: ClinicalTrials.gov record NCT04086511. Inclusion in this directory is not an endorsement.

PANDA: PKU Amino Acid Evaluation (NCT04086511) · Clinical Trials Directory