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Acceptability and Tolerance of a Ready-to-use Protein Substitute in Tablet Form for the Dietary Management of Phenylketonuria

NCT04375592 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2024-03-04

No results posted yet for this study

Summary

The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of phenylalanine-free protein substitute tablets for young children with PKU aged of 7 years or older.

Conditions

  • Phenylketonurias
  • Hyperphenylalaninaemia
  • Tetrahydrobiopterin Deficiency

Interventions

DIETARY_SUPPLEMENT

Phenylalanine-free protein substitute in tablet form (XPhe minis)

Intervention is a Phenylalanine-free protein substitute in tablet form. Subjects who currently take a concentrated second stage phenylalanine-free protein substitute will be recruited. Subjects will take the study product for 7 days and daily questionnaires will be completed. Subjects will replace some or all of their usual protein substitute with the new product. The amount of study product prescribed will be calculated to provide the same amount of protein as their usual protein substitute. Daily acceptability and tolerance questionnaires will record information on ease of preparation and administration; how it is taken; and any problems or gastrointestinal effects. Additional questions at the beginning and end of the study will record information on taste, appearance, smell, presentation and packaging of the product. Routine weekly finger prick blood spots will be collected and analysed for phenylalanine and tyrosine as usual.

Sponsors & Collaborators

  • Birmingham Children's Hospital

    collaborator OTHER

  • metaX Institut fuer Diatetik GmbH

    lead INDUSTRY

Principal Investigators

  • Anita MacDonald, Professor · Birmingham Children´s Hospital

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-05-01
Completion
2021-05-10

Countries

  • United Kingdom

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04375592 on ClinicalTrials.gov