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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2024 |
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Main ID: |
NCT05096988 |
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Date of registration:
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14/10/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of PKU Sphere Liquid
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Scientific title:
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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) |
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Date of first enrolment:
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November 23, 2021 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT05096988 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Anita Macdonald |
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Address:
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Telephone:
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Email:
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Affiliation:
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Birmingham Women's and Children's NHS Foundation Trust |
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Key inclusion & exclusion criteria
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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.
Age minimum:
3 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Phenylketonurias
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Intervention(s)
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Dietary Supplement: PKU sphere liquid
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Primary Outcome(s)
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Product acceptability rated on a Likert scale by the participant after four week intake
[Time Frame: 4 weeks]
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Questionnaire of self-reported changes in gastrointestinal tolerance during four week intake
[Time Frame: 4 weeks]
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Questionnaire of self-reported adherence to the prescribed amount of study product
[Time Frame: 4 weeks]
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Secondary ID(s)
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20/NW/0273
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MCT-GMPL-2018-02-21
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271801
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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