Pilot study on nutrition, cognition and bone health in children with Phenylketonuria (PKU)CogniBONE - Cognition & Bone

• Conditions: E70.0; E70.1; Classical phenylketonuria; Other hyperphenylalaninaemias

• Registration Number: DRKS00023752
• Lead Sponsor: niversitätsklinik für Kinder- und Jugendmedizin, Katholisches Klinikum Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-15
• Results First Posted: 2024-06-28
• Study Completion: 2024-07-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Children between 4 and 6 years

Exclusion Criteria

diagnosed learning disability;
a or an additional metabolic disease

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
control group: 1. Cognitive performance (tonic alertness, working memory, information processing speed) using a computer-based test system, 2. OCN concentrations in blood and urine, 3. nutritional behavior (questionnaire)<br><br>PKU patients: 1. Cognitive performance (tonic alertness, working memory, information processing speed) using a computer-based test system, 2. OCN concentrations in blood and urine, 3. blood phenylalanine concentrations + nutritional behavior (questionnaire)

Secondary Outcome Measures

Name	Time	Method
control group and PKU patients: 1. blood analysis: calcium, phosphate, vitamin D, parathormone, alkaline phosphatase, TRAP5b, P1NP, 2. urine analysis: calcium, phosphate, CTX-I