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Nutrition Status of Adults With PKU Before and During Treatment With Pegvaliase

Phenylketonurias Clinical Trial

Official title:
Longitudinal Assessment of Nutrition Status of Adults With PKU Before and During Treatment With Pegvaliase

Clinical Trial Summary

Conduct a prospective, longitudinal study to evaluate nutritional status in adults with phenylketonuria (PKU) before and during treatment with pegvaliase (Palynziq™).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03856203
Study type Observational
Source Boston Children's Hospital
Contact
Status Completed
Phase
Start date March 8, 2019
Completion date October 20, 2023
View Details
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