Skip to content

Multicenter-study to evaluate the supply of micronutrients of PKU-patients 7 years and older under a relaxed diet (phenylalanin-tolerance >800 mg/d)

Multicenter-study to evaluate the supply of micronutrients of PKU-patients 7 years and older under a relaxed diet (phenylalanin-tolerance >800 mg/d)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00004768
Enrollment
100
Registered
2013-02-28
Start date
2011-04-06
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: PKU-patients write a diet diary over 3 days and fill in a quality of life questionaire.

Sponsors

Universität Leipzig
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 100 Years

Inclusion criteria

Inclusion criteria: - PKU-patients with a phe tolerance >800 mg/day - PKU-patients which are healthy at the time of recruiting

Exclusion criteria

Exclusion criteria: - patients with psychological disorders - epilepsy - allergies - infections - chronical diseases following surgery at the gut, which influence the resorption, metabolism or secretion of food - other metabolic diseases besides PKU - using drugs regularily, exept the amino acid mixture and Sapropterin (Kuvan) - dystrophy (body weight <5th percentile) - other diets besides the PKU-diet - using supplements, besides the amino acid mixture

Design outcomes

Primary

MeasureTime frame
Nutritional behaviour measured at the daily supply of energy, protein, phenylalanin, carbohydrates, fat, calcium, vitamin D, vitamin B1, B2 and B12, iron, folic acid, zinc, selen, vitamin C, iodine

Secondary

MeasureTime frame
Qualitiy of life, measured with validated questionaires: KINDL (questionaire to determine health regarded quality of life for children and adolescents) and FLZ (questionaire to determine contentment of life) for patients 17 years and older.

Countries

Germany

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