Status:
COMPLETED
Nutrition Status of Adults Treated With Pegvaliase
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
BioMarin Pharmaceutical
Conditions:
Phenylketonurias
Eligibility:
All Genders
18-65 years
Brief Summary
Conduct a cross-sectional analysis of the nutritional status of individuals with PKU treated with pegvaliase for one or more years or who have followed an unrestricted diet for 6 or more months while ...
Eligibility Criteria
Inclusion
- Diagnosis of phenylketonuria
- Aged 18-65 years
- Currently treated with pegvaliase
- Have either 1) received treatment with pegvaliase for one or more years or 2) followed an unrestricted diet for 6 or more months while on pegvaliase
- Currently following an unrestricted diet that meets or exceeds the RDA for protein (0.8 g/kg/day)
Exclusion
- Unable to consent to study
- Under age 18 years or over age 65
- Routine food intake provides less than the RDA for protein (0.8 g/kg/d)
- Consuming any PKU medical foods
Key Trial Info
Start Date :
January 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03792451
Start Date
January 17 2019
End Date
December 31 2020
Last Update
March 4 2021
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115