CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 220 target
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01619722
NCT01619722N/ACompleted

Study of a National Cohort of Adult Patients With Phenylketonuria

University Hospital, Tours·observational·Posted Jun 14, 2012·Updated May 26, 2026

In Brief

An observational study for PKU and Hyperphenylalaninemia. Completed, enrolled 220 participants across 16 sites.

Detailed Summary

Phenylketonuria (PKU) is a metabolic disease of genetic origin. This is a rare disease (incidence 1 / 16000 births) which is the subject of a systematic neonatal screening in France, because it is treatable by a diet low in phenylalanine. This plan is required upon confirmation of diagnosis and continued until the age of 8 years. The current trend is to continue the scheme at least until adolescence. Unlike other countries, in France there are no recommendations for a plan "for life". Knowledge about the natural history of PKU in adulthood, the effects of pediatric age, the frequency of complicated shapes, and prognostic factors are poorly documented. On the other hand, there is no consensus on the therapeutic management of this disease in adulthood and monitoring that could be directed towards the detection of neurological disorders and nutrition. Social integration and quality of life of adults PKU patients living in France have not been studied.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2012
Enrollment StartMar 15, 2012
Primary CompletionFeb 15, 2020
Study CompletionJul 6, 2020
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 14.0 years ago