MedTrace Logo

Evaluating the Efficacy of PKU Synergy in Patients Expressing Phenylketonuria or Hyperphenylalaninemia

NCT03167697 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-03-13

No results posted yet for this study

Summary

This study centres around a new one-a-day phenylalanine-free protein substitute for phenylketonuria patients. Fifty eligible adults (≥ 16 years) with proven phenylketonuria or hyperphenylalaninemia will be recruited and randomly allocated to one of two intervention arms (n = 25 per arm). Following a 3-day baseline period, and in addition to routine nutritional management, patients will receive either one sachet of the new protein substitute daily (intervention) or continue their usual dietary and/or protein substitute regimen (maximum of 1 protein substitute per day (equal to 20g protein equivalent) control) for 28 days.

Conditions

  • Phenylketonurias
  • Hyperphenylalaninaemia, Type I

Interventions

DIETARY_SUPPLEMENT

Synergy

Small serving (x1 33 g serving daily) of the new phenylalanine-free protein substitute made up with 100mL of water daily (28 days).

OTHER

Routine

Patients will continue their usual dietary and/or protein substitute regimen (28 days).

Sponsors & Collaborators

  • Nutricia UK Ltd

    lead INDUSTRY

Principal Investigators

  • Rebecca Stratton, PhD · Nutricia UK

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-09-20
Completion
2018-12-17

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT03167697 on ClinicalTrials.gov