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Clinical Trials/NL-OMON45119
NL-OMON45119
Completed
Not Applicable

Executive and social functioning in early- and continuously-treated patients with PKU: A follow-up study 10 years later - Executive and social functioning in PKU patients

niversitair Medisch Centrum Groningen0 sites240 target enrollmentTBD
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ConditionsMetabolic diseasePKU1002742410021605

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic disease
Sponsor
niversitair Medisch Centrum Groningen
Enrollment
240
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Patients meet NIH\-diagnostic criteria for Hyperphenylalaninemia (HPA) or Phenylketonuria
  • •\- PKU patients were treated early (within one month after birth) and continuously (at least until age 12\)
  • •\- Born after 1974 (start national screening PKU) and minimum age of 7 years at time of study
  • •\- Dutch speaking
  • •\- PKU patients who use or used Tetrahydrobiopterin (BH4\) will not be excluded, but the use of this type of medication (which is being used to treat BH4\-responsive HPA/PKU\-patients) will be taken into account for statistical analyses (e.g. will be introduced as a covariate in between\-group comparisons)

Exclusion Criteria

  • •\- Mental retardation that has been diagnosed by the clinical centre, or if the IQ is below 80 (after assessment)
  • •\- Lack of fluency in Dutch
  • •\- Use of medication other than Tetrahydrobiopterin that may affect cognitive functioning
  • •\- Medical illnesses other than PKU with known effects on cognitive and social functioning

Outcomes

Primary Outcomes

Not specified

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