Status:
COMPLETED
A 16 Week Study Evaluating the Introduction of a GMP Based Protein Substitute in Participants With PKU
Lead Sponsor:
Vitaflo International, Ltd
Collaborating Sponsors:
Kreiskliniken Reutlingen
Johannes Gutenberg University Mainz
Conditions:
Phenylketonurias
Eligibility:
All Genders
10+ years
Phase:
NA
Brief Summary
This study aims to measure changes in participants' blood phenylalanine (Phe) levels in participants with PKU when switching from a conventional amino acid based protein substitute to a GMP based prot...
Detailed Description
This is a stepped wedge, open-label study of PKU Sphere for the dietary management of participants with Phenylketonuria. It will be carried out with 33 participants who will be randomised into one of ...
Eligibility Criteria
Inclusion
- Diagnosis of PKU made in neonatal period
- Treated by a low-phenylalanine diet and necessity of intake of at least one protein substitute per day
- Aged 10 years and above
- Three blood Phe measurements taken within the preceding six months
- Willing to replace current amino acid based protein substitute with PKU Sphere
- Ability to take at least 50% of protein requirements as PKU Sphere
- Ability to comply with the study protocol, in the opinion of the investigator
- Willingly given, written, informed consent from patient or parent/guardian
- Willingly given, written assent (if appropriate)
Exclusion
- Women who are pregnant or planning to become pregnant during the study period
- Participants with atypical PKU (e.g. BH4 deficient)
- Intake of sapropterin dihydrochloride (Kuvan) in the six weeks prior to recruitment in the study
- Patients with soya, milk or fish allergies
- Any other severe disease
Key Trial Info
Start Date :
December 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03771391
Start Date
December 6 2018
End Date
July 31 2023
Last Update
February 16 2024
Active Locations (1)
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1
Kreiskliniken Reutlingen
Reutlingen, Baden-Wurttemberg, Germany, D-72764