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 on pegvaliase treatment. We will evaluate laboratory markers of nutritional status, including markers of protein and micronutrient nutriture. In addition, a three-day food record and food frequency questionnaire will be obtained to assess protein intake and overall diet quality.
Conditions
Phenylketonurias
Recruitment Status
Completed
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Intervention
Intervention Type
Intervention Name
Drug
Pegvaliase
Gender
All
Min Age
18 Years
Max Age
65 Years
Download Date
March 4, 2021
Principal Investigator
Krista Viau
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: