Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT00909012
Eligibility Criteria:
Inclusion Criteria:
* Children with classical PKU, who have been diagnosed and treated from the newborn period onwards
* Classical PKU must have been established by a baseline plasma phenylalanine (PHE) level \>1200 µmol/L or detection of underlying mutations
* Children are clinically healthy besides classical PKU
* Good metabolic control (a minimum of 2 Phe-values during the last 6 months are needed with average Phe values being below 480 µmol/L in the last 6 months)
* No n-3 LC-PUFA supplementation for at least 6 months before enrolment
* Written informed consent of parents exists
Exclusion Criteria:
* Severe neurological symptoms
* History of neurological disease
* Children are unable to take DHA-capsules regularly
* Acute illness, especially infections at the time of clinical examination/testing
* Children with weight/height over the 97th percentile or below the 3rd percentile
* Known hypersensitivity to fish oil products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
13 Years
Study:
NCT00909012
Study Brief:
Protocol Section:
NCT00909012