Status:
COMPLETED
Impact of Fruit and Vegetables in PKU
Lead Sponsor:
Alex Pinto
Conditions:
Phenylketonurias
Eligibility:
All Genders
5-12 years
Phase:
NA
Brief Summary
In the UK, some fruits and vegetables are permitted without measurement in the diets of people with phenylketonuria (PKU). It is proven that fruits and vegetables containing phenylalanine (Phe) up to ...
Eligibility Criteria
Inclusion
- PKU patients diagnosed by NBS and BH4 deficiencies;
- Early and continuously treated;
- Adherent to their prescribed PKU diet consisting of a protein-restricted diet and Phe-free amino acid based protein substitute;
- In good general health as evidenced by medical history;
- Able to provide written informed consent/assent (parent/child);
- Able to comply with the study protocol and take study product according to the opinion of the PI;
- Patients with good metabolic control (age 5-12y, 120-360μmol/L) with 3 out of 4 levels within range prior to consent (if 2 of 4 above target range but one close to the upper limit, PI to decide if patient can enter the study).
Exclusion
- Concomitant diseases / disorders such as renal or gut disease / disorders and diabetes;
- Dislikes fruits and vegetables containing 76-100 mg of Phe/100g e.g.brocolli or cauliflower;
- Treated with BH4 (sapropterin);
- Presence of intercurrent infection;
- Patients with poor metabolic control (age 5-12y, \>360μmol/L).
Key Trial Info
Start Date :
July 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05249218
Start Date
July 20 2019
End Date
June 30 2021
Last Update
February 21 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham Women's and Children's Hospital
Birmingham, West Midlands, United Kingdom, B4 6NH