Status:
COMPLETED
Quantitative Requirements of Docosahexaenoic Acid for Neural Function in Children With Phenylketonuria
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
European Union
Conditions:
Phenylketonuria
Eligibility:
All Genders
5-13 years
Phase:
NA
Brief Summary
Patients with phenylketonuria (PKU) have an inborn error in the metabolism of the amino acid phenylalanine (Phe) and thus must follow a strictly controlled protein-restricted diet from early infancy. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00909012
Start Date
May 1 2009
End Date
March 1 2013
Last Update
August 22 2022
Active Locations (6)
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1
Zentrum für Kinder- und Jugendmedizin
Heidelberg, Germany, D-69120
2
LMU
München, Germany, D-80337
3
Department of Pediatrics, San Paolo Hospital Milano
Milan, Italy
4
Department of Pediatrics, IFIMAV-Hospital M. Valdecill
Santander, Spain