Status:
ACTIVE_NOT_RECRUITING
Evaluation of PKU UP
Lead Sponsor:
Vitaflo International, Ltd
Collaborating Sponsors:
Birmingham Women's and Children's NHS Foundation Trust
Conditions:
PKU
Eligibility:
All Genders
1-10 years
Phase:
NA
Brief Summary
PKU UP is a prospective, single-arm, open-label, 26-week acceptability study to evaluate PKU UP for the dietary management of participants with phenylketonuria (PKU). Up to 15 participants aged 1 - 10...
Detailed Description
PKU is a rare inborn error of metabolism with a prevalence of 1 in 10,000 in the UK population. The mainstay of treatment for most individuals is dietary therapy with a strict protein-restricted diet....
Eligibility Criteria
Inclusion
- Diagnosis of PKU requiring a low-protein diet and protein substitute.
- Participants who are adherent with their blood phenylalanine (Phe) testing, in the opinion of the investigator.
- Participants aged 1-10 years.
- Participants who in the opinion of the investigator are anticipated to be able to take at least half of their daily protein equivalent requirement from PKU UP (in order to assess this, a taste test (or similar) may be conducted at investigator's discretion as part of the screening process).
- Willingly given, written, informed consent from the parent(s)/guardian(s).
- Willingly given, written assent by the participant (if appropriate).
Exclusion
- Inability to comply with the study protocol, in the opinion of the investigator.
- Any co-morbidity, which, in the opinion of the investigator, would preclude participation in the study.
- Diagnosis of persistent hyperphenylalaninemia, or mild PKU not requiring a low protein diet and protein substitute.
- Allergy or intolerance to milk.
- Participants who are currently participating in, plan to participate in or have participated in an interventional investigational drug, food or medical device study within 30 days prior to the screening visit.
- Use of additional micronutrient supplements during the evaluation period, unless clinically indicated and prescribed by the Investigator (must be recorded in both the medical records and case report form).
Key Trial Info
Start Date :
January 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05995717
Start Date
January 11 2024
End Date
May 31 2026
Last Update
November 28 2025
Active Locations (7)
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1
Royal Belfast Hospital for Sick Children
Belfast, United Kingdom, BT12 6BE
2
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
3
St. Luke's Hospital
Bradford, United Kingdom, BD5 0NA
4
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom, BS2 8BJ