Status:
WITHDRAWN
Compliance, Tolerance and Acceptability of a Tablet Protein Substitute for the Dietary Management of Phenylketonuria
Lead Sponsor:
Nutricia UK Ltd
Conditions:
Phenylketonurias
Eligibility:
All Genders
8-100 years
Phase:
NA
Brief Summary
Thirty eligible PKU patients (≥ 8 years), identified as tablet protein substitute users, will be recruited. Patients will firstly observe a 7-day baseline period, in which participants will continue w...
Detailed Description
Protein substitutes are typically presented in powder format and reconstituted in water to a set volume, but may also be offered in ready-to-drink formats or as a gel. Notwithstanding recent advanceme...
Eligibility Criteria
Inclusion
- Male or female
- 8 years of age and older
- Diagnosed with proven PKU
- Consume a minimum of 20g protein equivalent in tablet format while enrolled on to the trial
- If routine care and dietary management is not different from normal PKU care and dietary management, preconception patients may be considered
- Have written informed consent from patient or parent/carer carer
Exclusion
- Requiring nutritional support (including enteral and parenteral nutrition)
- Major hepatic or renal dysfunction
- Maternal PKU patients (if a patient becomes pregnant during the study they will be withdrawn on immediate notice to the Metabolic Dietitian responsible for the patient's care)
- Participation in other studies within 1 month prior to entry of this study
- Investigator concern around willingness/ability of patient to comply with protocol requirements
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03333720
Start Date
July 15 2019
End Date
December 31 2019
Last Update
March 13 2019
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