Nutrition Status of Adults Treated With Pegvaliase

NCT03792451 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2021-03-04

No results posted yet for this study

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

Interventions

DRUG

Pegvaliase

Treated with pegvaliase for one or more years or followed an unrestricted diet for 6 or more months while being treated with pegvaliase.

Sponsors & Collaborators

Principal Investigators

  • Krista Viau, PhD, RD · Boston Children's Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-17
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03792451 on ClinicalTrials.gov