Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-12-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Low calorie protein substitute
Single arm designed, 3 day baseline, 28 day on the lower calorie amino acid based liquid protein substitute.
Low calorie protein substitute
The evaluated dietary supplement is a lower calorie amino acid based liquid protein substitute designed for patients with PKU.
Interventions
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Low calorie protein substitute
The evaluated dietary supplement is a lower calorie amino acid based liquid protein substitute designed for patients with PKU.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
3 Years
ALL
No
Sponsors
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Nutricia UK Ltd
INDUSTRY
Responsible Party
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Other Identifiers
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PKULite2018
Identifier Type: -
Identifier Source: org_study_id
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