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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: |
NCT03058848 |
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Date of registration:
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16/02/2017 |
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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 Start
PKU Start |
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Scientific title:
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A Study to Evaluate the Acceptability of a New Phenylalanine Free Infant Formula for Use in the Dietary Management of Phenylketonuria in Infants From Birth to 2 Year of Age With Regard to Product Tolerance and Adherence. |
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Date of first enrolment:
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March 6, 2017 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03058848 |
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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:
1. A diagnosis of classical or severe PKU on new-born screening (For the purposes of this
study, 'severe' is defined as phe concentrations between 120 and 600 µmol/L at
diagnosis)
2. Taking a minimum of one (1) feed of a Phe-free infant formula
3. A minimum period of four (4) weeks from the time of diagnosis to initial approach to
parents
Exclusion Criteria:
1. Diagnosed with mild PKU or hyperphenylalaninaemia (For the purposes of this study,
'mild' is defined as phe concentrations between 120 and 600 µmol/L at diagnosis)
2. Diagnosis of a congenital condition
Age minimum:
4 Weeks
Age maximum:
2 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Phenylketonuria
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Inborn Errors of Metabolism
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Intervention(s)
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Dietary Supplement: PKU Start
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Primary Outcome(s)
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GI tolerance daily diary
[Time Frame: Days 1-28]
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Daily phenylalanine control
[Time Frame: Days 1-28]
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Ease of use questionnaire
[Time Frame: Day 29]
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Product compliance daily diary
[Time Frame: Days 1-28]
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Secondary ID(s)
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209920
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17/NW/0035
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BCH-PKUSTART-032016-29
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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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