Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life — PKU-weaning  

PKU Clinical Trial

Official title: Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life: Acceptability and Efficacy of a New Protein Substitute

Status Completed

Clinical Trial Summary

In this study the feeding patterns and practices at the introduction of a second stage phe-free protein substitute will be assessed in young children with PKU. This will be compared with the normal weaning process in healthy non-PKU age-matched children. In addition, tolerability and acceptability of the study product will be evaluated in a smaller group of subjects who have already been transferred onto a second stage protein substitute. The study is performed in 3 centers in the United Kingdom.

Clinical Trial Description

Part 1:

For subjects with PKU, the study product will be incorporated in the diet as the second stage protein substitute until the subjects are 2 years of age.

The healthy non-PKU age-matched subjects will not have the study product incorporated in their diet in order to be able to compare the weaning experience and nutritional intake of PKU subjects with non-PKU subjects. The healthy subjects will also be part of the study until the subjects are 2 years of age.

Part 2:

All PKU subjects will take the study product for 7 days. ;

Related Conditions & MeSH terms

• PKU

• NCT number: NCT03913156
• Study type: Interventional
• Source: Nutricia Research
• Status: Completed
• Phase: N/A
• Start date: March 15, 2010
• Completion date: December 2016