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Investigation of the effects of nutrition and therapy on bone health in patients with elevated phenylalanine levels / phenylketonuria (PKU)

Investigation of the effects of nutrition and therapy on bone health in patients with elevated phenylalanine levels / phenylketonuria (PKU)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00023073
Enrollment
80
Registered
2020-11-27
Start date
2021-03-01
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: Patients with phenylketonuria (blood withdrawal, physical examination, nutrition questionnaire, life style questionnaire, cognition test) Group 2: healthy controls (blood withdrawal, physical

Sponsors

Universitätsklinik für Kinder- und Jugendmedizin, St. Josef-Hospital, Ruhr-Universität Bochum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: = 18 years and written-informed consent

Exclusion criteria

Exclusion criteria: Presence of a metabolic disease other than PKU, missing declaration of consent, patients who are not able to give consent, insufficient knowledge of the German language, Pregnancy and lactation, Pre-terminal or terminal renal failure

Design outcomes

Primary

MeasureTime frame
The primary hypothesis of the study is that bone health in PKU patients, as measured by significantly different levels of higher BPH (Bone pathology harbinger)-Score, is worse than that of control subjects of the same age and sex and shows further deterioration with increasing Phe levels over the past 5 years.

Secondary

MeasureTime frame
The secondary hypothesis is that differences between control subjects and PKU patients can also be found in cognitive performance, analyzed with a computer-based cognition test

Countries

Germany

Contacts

Public ContactBeatrice Hanusch

Forschungsdepartment Kinderernährung, Universitätsklinik für Kinder- und Jugendmedizin, St. Josef-Hospital, Ruhr-Universität Bochum

beatrice.hanusch@rub.de+49 234 5092615

Outcome results

None listed

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