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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: |
NCT03939052 |
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Date of registration:
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01/05/2019 |
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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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Protein Requirements in Adults With Phenylketonuria (PKU)
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Scientific title:
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Protein Requirements in Phenylketonuria (PKU) Patients Compared Using PKU Sphere™ | Glycomacropeptide (GMP) and an L-amino Acid-based Product |
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Date of first enrolment:
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July 19, 2019 |
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Target sample size:
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6 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03939052 |
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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: 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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Canada
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Contacts
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Name:
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Rajavel Elango, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Rajavel Elango, 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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BC Children's Hospital Research Institute, University of British Columbia |
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Name:
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Sandra Sirrs, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Rajavel Elango, PhD |
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Address:
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Telephone:
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604-875-2000 |
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Email:
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relango@bcchr.ubc.ca |
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Affiliation:
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Name:
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Sylvia Stockler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
-Adults more than 19 years of age who are diagnosed with PKU and clinically stable with no
acute illness
Exclusion Criteria:
- Adults with PKU under age 19 year
- Adults diagnosed with PKU but are currently ill with a fever or cold
Age minimum:
19 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Phenylketonuria
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Intervention(s)
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Dietary Supplement: Free amino acids intake
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Primary Outcome(s)
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13 Co2 production
[Time Frame: 8 hours (1 study day). 3 samples will collected as a baseline prior to isotope protocol and 6 samples after 2 hours and 30 minutes of starting the tracer protocol. Data will be reported an average of 2 years.]
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Lysine flux
[Time Frame: 8 hours (1 study day). 1 sample will collected as a baseline prior to isotope protocol and 2 samples after 2 hours and 30 minutes of starting the tracer protocol. Data will be reported an average of 2 years.]
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Secondary Outcome(s)
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Phenylalanine concentrations
[Time Frame: One sample (at 6th meal) after starting of the tracer protocol. Data will be reported an average of 2 years.]
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16 other amino acids
[Time Frame: One sample (at 6th meal) after starting of the tracer protocol. Data will be reported an average of 2 years.]
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Tyrosine concentrations
[Time Frame: One sample (at 6th meal) after starting of the tracer protocol. Data will be reported an average of 2 years.]
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Secondary ID(s)
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H18-03464
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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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