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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023752

Enrollment

Registered

2020-12-15

Start date

2018-09-20

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E70.0 E70.1

Interventions

Group 1: PKU patients: 1x questionnaire dietary habits, 1x blood and urine withdrawal, 1x computer-based cognitive testing Group 2: Control subjects: 1x questionnaire dietary habits, 1x blood and urin

Eligibility

Sex/Gender

All

Age

4 Years to 6 Years

Inclusion criteria

Inclusion criteria: Children between 4 and 6 years

Exclusion criteria

Exclusion criteria: diagnosed learning disability; a or an additional metabolic disease

Design outcomes

Primary

Measure	Time frame
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) 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)	—

Measure

Time frame

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) 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

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

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026