Nutrition Status of Adults Treated With Pegvaliase

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Trial Status Completed

Trial Identifier

NCT03792451

Condition

Phenylketonuria, Phenylketonurias

The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.

Trial 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.

Eligibility Criteria

Birth Sex

All

Age

18 Years to 65 Years

Healthy Volunteers

No

Drug/Treatment:

Pegvaliase

Study Type:

Observational

Number of Participants:

18

Study Started:

2019-01-17

Study Updated:

2021-03-04

Trial Locations

  • Boston Children's Hospital

    Boston, Massachusetts, United States

Inclusion Criteria

1. Diagnosis of phenylketonuria
2. Aged 18-65 years
3. Currently treated with pegvaliase
4. 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
5. Currently following an unrestricted diet that meets or exceeds the RDA for protein (0.8 g/kg/day)

Exclusion Criteria

1. Unable to consent to study
2. Under age 18 years or over age 65
3. Routine food intake provides less than the RDA for protein (0.8 g/kg/d)
4. Consuming any PKU medical food

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