Evaluation of a novel monitoring system for quantification of phenylalanine in whole blood and possible use as a point-of-care assay

Evaluation of a novel monitoring system for quantification of phenylalanine in whole blood and possible use as a point-of-care assay - PKU biosensor

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00013668

Enrollment

Registered

2018-01-19

Start date

2018-05-07

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: In patients with PKU/MHP who present for follow-up in our outpatient clinic and in whom blood is routinely taken for phe determination in plasma and dried blood spots phe is additionally dete

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with mild hyperphenylalaninemia or phenylketonuria (PKU) who present for follow-up in the metabolic outpatient clinic, University Children's Hospital Heidelberg.

Exclusion criteria

Exclusion criteria: Lack of informed consent for study participation.

Design outcomes

Primary

Measure	Time frame
The aim of the study is the validation of a new measuring system for quantification of phenylalanine (phe) in blood and plasma of PKU (phenylketonuria) patients. The new measuring system is compared to methods currently used for phe quantification in the University Children's Hospital Heidelberg.	—

Secondary

Measure	Time frame
Comparison of phe concentrations in different blood samples (whole blood, plasma, dried blood spots).	—

Countries

Germany

Contacts

Public ContactDorothea Haas

Universitätsklinikum Heidelberg Zentrum für Kinder- und Jugendmedizin Stoffwechselambulanz

kinderklinik.stoffwechselambulanz@med.uni-heidelberg.de+49-6221-564002

Outcome results

None listed

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