Simplified Diet Approach in Phenylketonuria

Completed · Not applicable

Conditions studied: Phenylketonuria

In brief

This is a study to determine if a simplified protein counting system, including the free usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in teens and adults with phenylketonuria (PKU). Anybody with a positive diagnosis of PKU, between the ages of 13-65 years will be invited to participate in this study. Subjects will be educated on the simplified system upon enrollment, and historical phenylalanine (Phe) levels will be used for comparison. Subjects will also be asked about their attitudes towards their current Phe counting system.

Key facts

Study ID

NCT02555579

Run by

University of Nebraska

People needed

33

Starts

2015-10-26

Expected to finish

2017-09-20

Last updated by the study team

2023-09-07

Who can join

Age: 13 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Positive diagnosis of PKU
• Males and females >13 year of age
• Currently on phenylalanine-restricted diet

You may not qualify if…

• Any woman planning, or becoming pregnant during study duration
• Any patient who starts Kuvan during the study, as Kuvan lowers phenylalanine levels in some patients.
• Any patient currently enrolled in other research studies (Prism 301/302 Protocol; Institutional Review Board Protocol # 376-13-FB)

Where it is running

• Monroe-Meyer Insititute — Omaha, Nebraska, United States
• Children's Hospital & Medical Center — Omaha, Nebraska, United States
• Nebraska Medicine, Midtown Health Center — Omaha, Nebraska, United States
• Unversity of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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