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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03820804 |
Date of registration:
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19/10/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Nutritional Status in Phenylketonuria
TNSPKU |
Scientific title:
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Trends in Nutritional Status of Patients With Phenylketonuria |
Date of first enrolment:
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January 7, 2019 |
Target sample size:
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94 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03820804 |
Study type:
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Observational |
Study design:
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Phase:
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Countries of recruitment
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Portugal
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Contacts
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Name:
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JĂșlio C Rocha, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Centro Hospitalar do Porto |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of PKU.
- With all the clinical data available since 2009.
- Have completed the annual routine nutritional status evaluation in the periods
2009/2010, 2011/2012, 2013/2014, 2015/2016 and 2017/2018.
- Maintaining a follow-up at Centro Hospitalar do Porto.
Exclusion Criteria:
- Lost of follow-up.
- Not have completed at least one full evaluation in each time period: 2009/2010,
2011/2012, 2013/2014, 2015/2016 and 2017/2018.
- Any other chronic medical condition which may affect diet or nutritional status.
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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Drug: Sapropterin
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Other: Diet
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Primary Outcome(s)
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Overweight and obesity incidence
[Time Frame: 2009-2018]
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Overweight and obesity prevalence
[Time Frame: 2009-2018]
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Secondary Outcome(s)
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Metabolic control (blood phenylalanine concentration)
[Time Frame: 2009-2018]
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Metabolic control (blood phenylalanine concentration) and sapropterin
[Time Frame: 2015-2018]
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Metabolic syndrome prevalence
[Time Frame: 2009-2018]
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Phenylalanine intake and sapropterin
[Time Frame: 2015-2018]
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Body composition using bioelectrical impedance analysis
[Time Frame: 2009-2018]
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Metabolic syndrome incidence
[Time Frame: 2009-2018]
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Secondary ID(s)
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Nutrition_PKU
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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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