Status:
WITHDRAWN
PKU Low Calorie Drink Study
Lead Sponsor:
Nutricia UK Ltd
Conditions:
Phenylketonurias
Hyperphenylalaninaemia
Eligibility:
All Genders
3+ years
Phase:
NA
Brief Summary
This study will evaluate the compliance, acceptability, gastrointestinal (GI) tolerance and safety of a lower calorie amino acid based liquid protein substitute for patients with Phenylketonuria (PKU)...
Eligibility Criteria
Inclusion
- Male or female
- 3 years of age or above
- Diagnosed with classical or variant type phenylketonuria (PKU), or hyperphenylalaninemia (HPA)
- Have been compliant in taking at least one amino acid-based, Phe-free protein substitute, providing at least 20g protein equivalent daily, for at least 1 month prior to study commencement
- Have a prescribed daily Phe allowance
- Written informed consent from patient, or from parent / carer if applicable
Exclusion
- Pregnant or lactating
- Requiring enteral tube or parenteral nutrition
- Major hepatic or renal dysfunction
- Participation in other studies within 1 month prior to entry to this study
- Allergy to any of the study product ingredients
- Investigator concern around the patient being underweight (e.g.: BMI lower than 18.5kg/m2 for adults) and/or having an eating disorder
- Investigator concern around willingness/ability of patient or parent/carer to comply with protocol requirements
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04272736
Start Date
December 1 2023
End Date
December 31 2023
Last Update
February 26 2025
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