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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: |
NCT01965691 |
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Date of registration:
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16/10/2013 |
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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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Protein Requirements in Children With Phenylketonuria (PKU)
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Scientific title:
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Application of Stable Isotopes to Determine Protein Requirements in Children With Phenylketonuria (PKU) |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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4 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01965691 |
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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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Keiko Ueda, MPH, RD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Provincial Health Services Authority |
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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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Child and Family Research Institute, University of British Columbia |
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Name:
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Sylvia Stockler-Ipsiroglu, 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:
- Children (5-18y) who are diagnosed with Phenylketonuria (PKU), and clinically stable
with no acute illness
Exclusion Criteria:
- Children less than 5y of age and who are diagnosed with PKU, as it may be difficult to
take breath samples and perform indirect calorimetry in very young children.
- Children diagnosed with PKU, but are currently ill, with a fever, cold, vomiting or
diarrhea.
Age minimum:
5 Years
Age maximum:
18 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: Protein intake
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Primary Outcome(s)
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13 Co2 production
[Time Frame: 8 hours (1 study day)]
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Secondary ID(s)
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H13-00220
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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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