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Evaluation of PKU Sphere in Maternal PKU

NCT04224142 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2025-11-28

No results posted yet for this study

Summary

This observational study aims to recruit females, aged 16 years and over, with phenylketonuria (PKU) or hyperphenylalaninemia (hyperphe) following dietary management advice pre-conception and/or during pregnancy, who are willing to take PKU sphere as part of their dietarty management.

Conditions

  • Maternal Phenylketonuria

Interventions

DIETARY_SUPPLEMENT

PKU sphere

PKU sphere is a Food for Special Medical Purposes (FSMP). This product is for use in the dietary management of phenylketonuria (PKU). It is a powdered, low phenylalanine medical food containing a balanced mix of GMP, essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, and DHA. It is available in 27g sachets providing 15g PE and contains 28mg Phe and 35g sachets providing 20g PE and contains 36mg Phe.

Sponsors & Collaborators

  • University College London Hospitals

    collaborator OTHER

  • Vitaflo International, Ltd

    lead INDUSTRY

Principal Investigators

  • Charlotte Ellerton · University College London Hospitals

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-29
Primary Completion
2025-10-07
Completion
2025-10-07

Countries

  • United Kingdom

Study Locations

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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 NCT04224142 on ClinicalTrials.gov