Phenylketonurias Clinical Trial
Official title:
A Study to Evaluate the Acceptability, Tolerance and Adherence of Children and Adults Consuming PKU Sphere Liquid, a Food for Special Medical Purposes (FSMP), for the Dietary Management of Phenylketonuria (PKU)
Verified date | February 2024 |
Source | Vitaflo International, Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
PKU Sphere Liquid is a prospective, open-label, acceptability study to evaluate PKU sphere liquid in up to 15 participants aged 3 and above for the dietary management of PKU over 31 days.
Status | Completed |
Enrollment | 19 |
Est. completion date | February 28, 2023 |
Est. primary completion date | June 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of PKU requiring a low protein diet and protein substitute. - Aged three (3) years and over - Already taking a minimum of one GMP based protein substitute per day or have previously taken one - Able to comply with the study protocol and take the study product, according to the opinion of the PI. - Willingly given, written, informed consent from patient or parent/guardian. - Willingly given, written assent (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 hyperphenylalaninaemia, or mild PKU not requiring dietary intervention with a low protein diet and protein supplement. - Unwilling/unable to take a GMP based protein substitute. - Women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study period. N.B.: Women who become pregnant unexpectedly during this study will be immediately withdrawn from the study. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Victoria Hospital | Belfast | |
United Kingdom | Birmingham Children's Hospital | Birmingham | |
United Kingdom | Northern General Hospital | Sheffield |
Lead Sponsor | Collaborator |
---|---|
Vitaflo International, Ltd |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Questionnaire of self-reported adherence to the prescribed amount of study product | Assessment of participant's adherence to prescribed amount during the eight week intake of the study product | 4 weeks | |
Primary | Product acceptability rated on a Likert scale by the participant after four week intake | Assessment of participant's acceptability following four week intake of the study product Scale is from 1 to 5: 1 = Loved it, 5 = Really didn't like it | 4 weeks | |
Primary | Questionnaire of self-reported changes in gastrointestinal tolerance during four week intake | Assessment of participant's gastrointestinal tolerance during the four week intake of the study product | 4 weeks |
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