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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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12 December 2020 |
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Main ID: |
NCT03167697 |
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Date of registration:
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22/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluating the Efficacy of PKU Synergy in Patients Expressing Phenylketonuria or Hyperphenylalaninemia
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Scientific title:
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Evaluating the Efficacy of PKU Synergy in Patients Expressing Phenylketonuria or Hyperphenylalaninemia |
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Date of first enrolment:
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May 1, 2017 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03167697 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. 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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Rebecca Stratton, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nutricia UK |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female
- Over 16 years of age
- Diagnosed with proven PKU or hyperphenylalaninemia with an increased
phenylalanine-tolerance/intake
- Currently taking a maximum of 1 protein substitute per day (equal to 20g protein
equivalent)
- Have a minimum blood phenylalanine level of = 600 umol/L (for PKU patients)
- Have relaxed (if not stopped) their dietary and protein substitute regimen for at
least 1 month prior to trial commencement
- Have Written informed consent from patient
Exclusion Criteria:
- Pregnant or lactating
- Requiring nutritional support (including enteral and parenteral nutrition)
- Major hepatic or renal dysfunction
- Participation in other studies within 1 month prior to entry of this study
- Allergy to any of the study product ingredients, including milk protein or soya
- Investigator concern around willingness/ability of patient to comply with protocol
requirements
Age minimum:
16 Years
Age maximum:
100 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Phenylketonurias
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Hyperphenylalaninaemia, Type I
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Intervention(s)
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Dietary Supplement: Synergy
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Other: Routine
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Primary Outcome(s)
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Nutritional Status (objective measure)
[Time Frame: 2 days]
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Secondary Outcome(s)
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Daily compliance with prescribed protein substitute as assessed by standarised questionnaire
[Time Frame: 31 days]
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Metabolic Control
[Time Frame: 2 days]
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Acceptability as assessed by standarised questionnaire
[Time Frame: 2 days]
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Gastrointestinal tolerance as assessed by standarised questionnaire
[Time Frame: 12 days]
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Nutritional Status (Objective measure)
[Time Frame: 2 days]
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Nutritional Status (subjective measure)
[Time Frame: 6 days]
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Anthropometry
[Time Frame: 2 days]
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Subjective Mood
[Time Frame: 3 days]
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Secondary ID(s)
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PKUSyn.2017
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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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