PhenylketonuriaTCA-PKUNCT07698743
Eating Disorders in Patients With Phenylketonuria
An observational study of Phenylketonuria, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The prevalence of eating disorders and BMI are significantly higher in PKU patients than in the general population. The protein-restricted diet associated with high carbohydrate intake and the severity of the genetic defect and disease can lead to weight gain in these patients; However, the link between restrictive… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Phenylketonuria
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2025to 2 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Subjects followed for PKU at Nancy University Hospital
Who may be able to join
- Subjects followed for PKU at Nancy University Hospital
- Subjects willing to participate
Who cannot join
- Subjects not villing to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Nancy, 54000
Eva Feigerlova, MD, PhD, MMEd, 00330383154796
Feigerlova, e.feigerlova@chru-nancy.fr
About this study
The prevalence of eating disorders and BMI are significantly higher in PKU patients than in the general population. The protein-restricted diet associated with high carbohydrate intake and the severity of the genetic defect and disease can lead to weight gain in these patients; However, the link between restrictive diets, EDs, and obesity has not been demonstrated in patients with PKU. These issues remain poorly explored, meaning that patients may not be detected and treated.
- Conditions
- Phenylketonuria
- Medical subject headings
- Phenylketonurias
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotypes related to TCA in the PCU cohort of the Reference Center for Hereditary Metabolic Diseases
Measured: from january 2026 to january 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start4 Dec 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion2 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PhenylketonuriaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698743
- Sponsor's protocol ID
- 2025PI143_TCA-PCU
- Acronym
- TCA-PKU
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Wegberg AMJ, MacDonald A, Ahring K, Belanger-Quintana A, Beblo S, Blau N, Bosch AM, Burlina A, Campistol J, Coskun T, Feillet F, Gizewska M, Huijbregts SC, Leuzzi V, Maillot F, Muntau AC, Rocha JC, Romani C, Trefz F, van Spronsen FJ. European guidelines on diagnosis and treatment of phenylketonuria: First revision. Mol Genet Metab. 2025 Jun;145(2):109125. doi: 10.1016/j.ymgme.2025.109125. Epub 2025 Apr 30.
PubMed 40378670
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Disorders in Patients With Phenylketonuria
- ClinicalTrials.gov ID
- NCT07698743
- Acronym / sponsor ID
- TCA-PKU / 2025PI143_TCA-PCU
- Conditions
- Phenylketonuria
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 2 Apr 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of eating disorders and BMI are significantly higher in PKU patients than in the general population. The protein-restricted diet associated with high carbohydrate intake and the severity of the genetic defect and disease can lead to weight gain in these patients; However, the link between restrictive diets, EDs, and obesity has not been demonstrated in patients with PKU. These issues remain poorly explored, meaning that patients may not be detected and treated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects followed for PKU at Nancy University Hospital
Key inclusion criteria (2 listed)
- Subjects followed for PKU at Nancy University Hospital
- Subjects willing to participate
Key exclusion criteria (1 listed)
- Subjects not villing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phenotypes related to TCA in the PCU cohort of the Reference Center for Hereditary Metabolic Diseases
Time frame: from january 2026 to january 2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Results publication: PubMed 40378670van Wegberg AMJ, MacDonald A, Ahring K, Belanger-Quintana A, Beblo S, Blau N, Bosch AM, Burlina A, Campistol J, Coskun T, Feillet F, Gizewska M, Huijbregts SC, Leuzzi V, Maillot F, Muntau AC, Rocha JC, Romani C, Trefz F, van Spronsen FJ. European guidelines on diagnosis and treatment of phenylketonuria: First revision. Mol Genet Metab. 2025 Jun;145(2):109125. doi: 10.1016/j.ymgme.2025.109125. Epub 2025 Apr 30.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phenylketonuria, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Feigerlova, MD PhD MMEd (+330383154796, e.feigerlova@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotypes related to TCA in the PCU cohort of the Reference Center for Hereditary Metabolic Diseases (time frame: from january 2026 to january 2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07698743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.