Status:
COMPLETED
Evaluation of PKU Sphere
Lead Sponsor:
Vitaflo International, Ltd
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Phenylketonurias
Eligibility:
All Genders
3+ years
Phase:
NA
Brief Summary
A prospective, open-label study of PKU Sphere in patients with PKU following a phenylalanine restricted therapeutic diet.
Detailed Description
The rationale for this study is to assess acceptability, adherence and metabolic control in individuals with PKU consuming PKU Sphere, a GMP-based medical food. The sponsor developed PKU Sphere in re...
Eligibility Criteria
Inclusion
- Diagnosis of PKU, identified by newborn screening (NBS) and treated since birth.
- Ages 3 years and above (this includes pregnant women who will be assessed on an individual basis by the Co-Principal Investigators).
- Currently or previously consuming a low phenylalanine diet supplemented with a medical food designed for the dietary management of PKU.
- English as primary language.
- Willingly given, written, informed consent from the participant, 18 or more years, or from the parent/caregiver for participants \< 18 years.
- Willingly given, written assent (if appropriate) for those \< 18 years.
Exclusion
- Currently consuming 100% of the medical food component of the diet as PKU sphere.
- An inability, in the opinion of the investigator, to comply with the requirements of the protocol.
- Any other type of inherited metabolic disease.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03419819
Start Date
May 1 2018
End Date
May 21 2019
Last Update
February 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oregon Health and Science University
Portland, Oregon, United States, 97239