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Evaluation of PKU Sphere

NCT03419819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-02-16

No results posted yet for this study

Summary

A prospective, open-label study of PKU Sphere in patients with PKU following a phenylalanine restricted therapeutic diet.

Conditions

  • Phenylketonurias

Interventions

DIETARY_SUPPLEMENT

PKU Sphere

PKU Sphere is a glycomacropeptide based alternative to amino-acid based products for the dietary management of phenylketonuria.

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • Vitaflo International, Ltd

    lead INDUSTRY

Principal Investigators

  • Sandra Van Calcar, PhD · Oregon Health and Science University

  • Joyanna Hansen, PhD · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2019-05-21
Completion
2019-05-21

Countries

  • United States

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 NCT03419819 on ClinicalTrials.gov