Status:
COMPLETED
Effects of Synergy on Nutrient Intake and Acceptability in Phenylketonuria (PKU)
Lead Sponsor:
Nutricia Research
Conditions:
Phenylketonurias
Eligibility:
All Genders
12+ years
Phase:
NA
Brief 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 Pheny...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- PKU subjects identified by newborn screening and started low-Phe diet before 3 months of age
- PKU subjects (with or without current AAM use) with an increased Phe-tolerance/intake due to:
- Mild PKU phenotype
- BH4 treatment
- If treated with BH4, PKU subjects should be on a stable BH4 treatment for at least 26 consecutive weeks up to start test product intake
- Age≥12 years
- If subjects (irrespective whether BH4 users or mild PKU) use amino-acid mixture(s; AAM), then a maximum of 25 Protein Equivalents (PE) derived from the AAM per day applies and usage on a daily basis for at least 26 consecutive weeks up to Visit 1
- If subjects (irrespective whether BH4 users or mild PKU) use AAMs they should be capable and willing to substitute their current AAM(s; maximum of 25 PE per day) with one portion of the test product per day
- If subjects (irrespective whether BH4 users or mild PKU) use omega-3, antioxidant, and/or vitamin supplements, to stop usage of the supplements and be able and willing to substitute with the test product
- Willing and able to comply with study procedures
- Willing and able to provide informed consent (and assent in case of minors if required by local law/regulations)
- For women of childbearing potential: not to have the intention to become pregnant during the study
- Exclusion Criteria:
- For women: Currently pregnant or lactating
- Current or prior use of the test product within six weeks prior to entry into the study
- Concurrent conditions (including renal failure and severe hepatic failure) and medication that could interfere with participation, outcome parameters or safety (as determined by Investigator)
- Psychotropic medication (i.e. medication affecting the nervous system) and inotropic medication
- Any condition creating high risk of poor compliance with study
- Participation in any other studies involving investigational or marketed products concomitantly or within six weeks prior to entry into the study. Except for studies related to Kuvan® (synthetic tetrahydrobiopterin (BH4)) without diagnostic, therapeutic or experimental intervention.
Exclusion
Key Trial Info
Start Date :
June 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03777826
Start Date
June 26 2019
End Date
May 27 2021
Last Update
December 9 2021
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University hospital Leipzig
Leipzig, Germany
2
University hospital Münster
Münster, Germany
3
University Medical Center Groningen (UMCG)
Groningen, Netherlands