Use of Glycomacropeptides (GMP) in 3 – 11 year old children with classical Phenylketonuria in comparison to free amino acid (AAM) supplementation: Effect on metabolic control, micronutrient supply and wellbeing.

Use of Glycomacropeptides (GMP) in 3 – 11 year old children with classical Phenylketonuria in comparison to free amino acid (AAM) supplementation: Effect on metabolic control, micronutrient supply and wellbeing. - GMP in PKU children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031977

Enrollment

Registered

2023-06-12

Start date

2022-06-09

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

ORPHA:79254 E70.0

Interventions

Group 1: Patients from 3 to 11 years with classical PKU and therefore low Phe-tolerance receive for three weeks a mixture of amino acids, which represents the treatment before the study. After two we

Eligibility

Sex/Gender

All

Age

3 Years to 11 Years

Inclusion criteria

Inclusion criteria: Patients with classical PKU 1. Age 3-11 years 2. Signed consent (patients and caregivers)

Exclusion criteria

Exclusion criteria: 1. acute illness at start of the study, in particular infections as they might intermittingly deteriorate metabolic control 2. every chronic disease or outcome of surgery on the gastrointestinal tract, which influences resorption, metabolism or excretion of food other than PKU.

Design outcomes

Primary

Measure	Time frame
To compare the treatment with GMP to the standard use of AAM, in 3-11 year old patients with PKU, regarding 1.metabolic control (Phe < 360 µmol/l) 2.Phe tolerance 3.variability of blood Phe concentrations 4.tyrosine blood concentrations 5.micronutrient serum concentrations (vitamin A, D, E, K, B12, folic acid, ferritin, zinc, selenium, calcium)	—

Secondary

Measure	Time frame
To compare the treatment with GMP to the standard use of AAM, in 3-11 year old patients with PKU, regarding 1. palatability 2. satiation 3. gastro intestinal wellbeing	—

Countries

Germany

Contacts

Public ContactSkadi Beblo

Klinik für Kinder- und Jugendmedizin der Universiätsklinik Leipzig

Skadi.Beblo@medizin.uni-leipzig.de+493419726224

Outcome results

None listed

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