Nutrition Status of Adults Treated With Pegvaliase

Completed

Conditions studied: Phenylketonurias

In brief

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.

Key facts

Study ID

NCT03792451

Run by

Boston Children's Hospital

People needed

18

Starts

2019-01-17

Expected to finish

2020-12-31

Last updated by the study team

2021-03-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.