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Multi center study to eveluate the kind of performance of the diet of children and young adults with phenylketonuria (PKU), who have a phe-tolerance of max. 800 mg.

Multi center study to eveluate the kind of performance of the diet of children and young adults with phenylketonuria (PKU), who have a phe-tolerance of max. 800 mg.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00004732
Enrollment
200
Registered
2013-02-15
Start date
2012-12-20
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

Interventions

Group 1: We are doing a single survey with a self developed questinaire. The answers will determe to which group the patient will belong. group 1: very strict diet, Group 2: group 2: strict diet, Gr

Sponsors

Universitätsklinikum Leipzig
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: male and female patients with PKU, who are 1-18 years old

Exclusion criteria

Exclusion criteria: - patients do another diet besides the PKU-diet - patients take part in another studyn during the last 6 months, which influenced the diet or metabolic control - patients have another chronical desease or surgery at the intestinal tract which influences the resorption, metabolism of food. - patients do not want to take part in the study

Design outcomes

Primary

MeasureTime frame
Amount of phe-concentrations above therapeuc range out of the last 6 blood samples. Data are collcted on the questionaire.

Secondary

MeasureTime frame
Mean phe-concentration out of the last 6 blood samples. Data are collcted on the questionaire.

Countries

Austria, Germany, Switzerland

Contacts

Public ContactCarmen Rohde

Universitätsklinik und Poliklinik für Kinder und Jugendliche

carmen.rohde@uniklinik-leipzig.de0049-341-9726350

Outcome results

None listed

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