ClinicalTrials.Veeva

Menu

Nutrition Status of Adults Treated With Pegvaliase

Boston Children's Hospital logo

Boston Children's Hospital

Status

Completed

Conditions

Phenylketonurias

Treatments

Drug: Pegvaliase

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03792451
P00029611

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 foods

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems