Current Environment:

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

Minimum Age

18 Years

Maximum 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: