Evaluation of PKU UP
- Conditions
- PKU
- Registration Number
- NCT05995717
- Lead Sponsor
- Vitaflo International, Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria:<br><br> - Diagnosis of PKU requiring a low-protein diet and protein substitute.<br><br> - Participants who are adherent with their blood phenylalanine (Phe) testing, in the<br> opinion of the investigator.<br><br> - Participants aged 1-10 years.<br><br> - Participants who in the opinion of the investigator are anticipated to be able to<br> take at least half of their daily protein equivalent requirement from PKU UP (in<br> order to assess this, a taste test (or similar) may be conducted at investigator's<br> discretion as part of the screening process).<br><br> - Willingly given, written, informed consent from the parent(s)/guardian(s).<br><br> - Willingly given, written assent by the participant (if appropriate).<br><br>Exclusion Criteria:<br><br> - Inability to comply with the study protocol, in the opinion of the investigator.<br><br> - Any co-morbidity, which, in the opinion of the investigator, would preclude<br> participation in the study.<br><br> - Diagnosis of persistent hyperphenylalaninemia, or mild PKU not requiring a low<br> protein diet and protein substitute.<br><br> - Allergy or intolerance to milk.<br><br> - Participants who are currently participating in, plan to participate in or have<br> participated in an interventional investigational drug, food or medical device study<br> within 30 days prior to the screening visit.<br><br> - Use of additional micronutrient supplements during the evaluation period, unless<br> clinically indicated and prescribed by the Investigator (must be recorded in both<br> the medical records and case report form).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in phe level between baseline and visit 3;Change in tyrosine level between baseline and visit 3;Change in PI impression of metabolic control;Change in the growth of participants as measured by Height (length in under 2 years of age), Head circumference in under 2 years of age and Weight.;Change in GI tolerance (participant);Change in PI impression of GI tolerance;Change in compliance with study product consumption;Change in PI impression of study product intake;Change in product acceptability;Change in dietary intake;Change in nutritional biochemistry
- Secondary Outcome Measures
Name Time Method