Evaluation of PKU UP (PKU UP)
PKU
About this trial
This is an interventional treatment trial for PKU focused on measuring Phenylketonuria, PKU, Glyco-Macro-Peptide, GMP, amino acid, AA, protein substitute, PS, United Kingdom, UK, children, PKU UP, Glycomacropeptide
Eligibility Criteria
Inclusion Criteria: 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 are anticipated to be able to take at least half of their daily protein equivalent requirement from PKU UP. Willingly given, written, informed consent from the parent(s)/guardian(s). Willingly given, written assent by the participant (if appropriate). Exclusion Criteria: 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).
Sites / Locations
- Royal Belfast Hospital for Sick Children
- Birmingham Children's Hospital
- University Hospitals Bristol and Weston NHS Foundation Trust
- Great Ormond Street Hospital for Children NHS Foundation Trust
Arms of the Study
Arm 1
Experimental
PKU UP
All participants will be assessed by their dietitian and prescribed an appropriate amount of the study product, PKU UP, to manage their phenylketonuria.