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COMPLETEDNCT04086511

PANDA: PKU Amino Acid Evaluation

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 Pheny...

Lead sponsor: Nutricia Research•2 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Nutricia Research

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.

Age

2 - 12 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Both PKU and Non-PKU comparison subjects:
•1. Age ≥ 2 and ≤ 12 years
•2. Willing and able to provide informed consent by parents or legal representatives (and assent if required by local law/regulations)
•3. One subject per family
•4. PKU subjects identified by newborn screening and started low Phe diet before 1 month age
•5. Usage of at least two Phe-free protein substitutes on a daily basis for at least 26 consecutive weeks up to Visit 1
•6. Average Phe-level ≤360 µmol/L based on at least two blood Phe values from the past 12 months up to Visit 1
•7. Same age (±3 years) and sex as an included PKU subject

Exclusion Criteria

•Both PKU and Non-PKU comparison subjects:
•1. Current psychiatric disorders
•2. Severe hepatic, thyroid or renal dysfunction
•3. Acute illnesses like fever, flu, diarrhea, or vomiting (subjects should be symptom free for a week prior to V1)
•4. Serious conditions (e.g. cancer, hydrocephalus, fatal heart disease)
•5. Participation in any other clinical intervention studies involving test products concomitantly or within six weeks prior to entry into the study
•6. Use of BH4, or drugs that may interfere with main outcomes
•7. PKU diagnosis or any other diagnosed disorder of amino or organic acid metabolism

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 2, 2023Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment37

Start dateSep 2019

Last updatedJun 2, 2023

Condition

Phenylketonuria (PKU)

Locations shown

Dr. P. Verloo

Ghent

Birmingham Children's Hospital

Birmingham

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 2, 2023Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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