Trials / Completed
CompletedNCT03856203
Nutrition Status of Adults With PKU Before and During Treatment With Pegvaliase
Longitudinal Assessment of Nutrition Status of Adults With PKU Before and During Treatment With Pegvaliase
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (actual)
- Sponsor
- Boston Children's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Conduct a prospective, longitudinal study to evaluate nutritional status in adults with phenylketonuria (PKU) before and during treatment with pegvaliase (Palynziq™).
Detailed description
The investigators will compare intra-subject change in adults with PKU who follow a protein-restricted diet (protein intake less than the RDA for protein based on weight (0.8 g/kg/day) with or without a PKU medical food) within 90 days of starting pegvaliase (baseline) and 9 and 15 months later. The investigators will collect laboratory measures of nutrition status, anthropometrics, Dual-Energy X-Ray Absorptiometry (DXA) to measure body composition and bone mineral density (BMD), and indirect calorimetry to measure resting energy expenditure (REE). In addition, three-day food records will be obtained to assess protein intake and overall diet quality.
Conditions
Timeline
- Start date
- 2019-03-08
- Primary completion
- 2022-12-31
- Completion
- 2023-10-20
- First posted
- 2019-02-27
- Last updated
- 2023-11-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03856203. Inclusion in this directory is not an endorsement.