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PKU diet in childhood may shape adult IQ, study finds

NCT ID NCT04433728

Knowledge-focused Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at adults with phenylketonuria (PKU) who were diagnosed as newborns and treated with a special diet. Researchers want to see if how long and how strictly they followed the diet as children affects their intelligence (IQ) as adults. The goal is to use this information to improve future dietary recommendations for children with PKU.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors refine dietary guidelines for children with PKU to improve their long-term thinking and memory.
What could go wrong
This study was terminated early and only includes 42 people from one region, so results may not apply widely. It looks back at past records, which can be less reliable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

42 people

The number who actually took part.

Started

Dec 2021

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All adult patients screened in Nord Pas de Calais for PKU in the neonatal period since 1971 and treated with a diet and / or drug treatment

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with classic or atypical phenylketonuria detected in the neonatal period since 1971 in the department of Nord (59) and Pas de Calais (62). * Patients treated * Able to receive information * Patient beneficiary or affiliated to a social security Exclusion Criteria: * Patients not screened (born outside French territory) or before 1971. * Untreated screened patients * Patients screened for persistent benign hyperphenylalaninaemia not treated with a diet (Phenylalanine level \<10 mg / dl or 600 µmol / l without diet to be confirmed) * Associated confirmed neurological pathology other than a complication of phenylketonuria. * Refusal to participate in the assessment of Intellectual Quotient in adulthood * Patient screened, lost to follow-up, found, having moved to another region and not wishing to return to the CHU for follow-up. * Inability to receive information and or express opposition * Opposition to participation in the study

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Conditions

The condition(s) this trial relates to.

phenylketonuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Phenylketonurias

Contacts and locations

Locations

  • chu de Lille

    Lille, France

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