E70.0
Conditions
Interventions
Group 1: 2 weeks of calculating the consumed fruits and vegetables is followed by 2 weeks of not calculating. Observation after 6 an 12 month is the same in both study arms.
Group 2: 2 weeks of not ca
Sponsors
Universitätsklinik und Poliklinik für Kinder und Jugendliche
Eligibility
Sex/Gender
All
Age
2 Years to 10 Years
Inclusion criteria
Inclusion criteria: 1. Male and female children from age 2-10 years. 2. the patients are clinical healthy, except of PKU 3. The patients or their guardians signed the letter of agreement.
Exclusion criteria
Exclusion criteria: - taking part in another clinical trial - not be able to meet the criteria of the study - patients with psychological diseases - epilepsy - loss of blood >500 ml during the last 3 month - severe allergic diuresis - severe organic diseases - infections during the intervention - all chronic diseases or outcomes of surgeries at the alimentary tract - refusal to be part of the study - other metabolic diseases, except PKU - regular intake of medication, except the mixture of amino acids - dystrophy - other diet, besides the PKU-diet - regular intake of nutrient substitutes, except the mixture of amino acids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of risen phenylalanine blood levels: Phenylalanine is measured in the mornings - one time enting the trial - on 5 days during the periode of calculating - on 5 days during the periode of not calculating - on 3 days after 6 month - on 3 days after 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual mean und standard deviation score of phenylalanine, and the amount of consumed fruits an vegetables | — |
Countries
Germany
Contacts
Public ContactCarmen Rohde
Universitätsklinik und Poliklinik für Kinder und Jugendliche
Outcome results
None listed