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Metabolic Control and Patient Well-being in Phenylketonuria: do Guidelines Make a Difference?

NCT05128149 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-04-13

No results posted yet for this study

Summary

Treatment of PKU implies for most patients that with strict adherence to dietary treatment they can achieve excellent neurocognitive outcome. Dietary treatment, though, is hard to comply to every day and with every single meal. Unsurprisingly, health-related quality of life (HrQol) is negatively affected if patients have to follow a dietary regime of this kind. Adherence to treatment in PKU is very variable. Factors of significant impact on adherence to treatment and well-being in chronic disease such as self-efficacy or parenting stress have not yet been widely investigated in PKU patients.

The ideal treatment prescription (and guideline) recommends as much as necessary and as little as possible, based on the best evidence available. Patients should neither be deprived of treatment options nor be exposed to overtreatment.

This study investigates adherence, metabolic control, HrQol in PKU patients treated by centres which follow different guidelines

Conditions

  • Phenylketonurias

Interventions

OTHER

no intervention

no intervention

Sponsors & Collaborators

  • UChildrenVienna

    collaborator UNKNOWN

  • University Children's Hospital Basel

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER

  • University Children's Hospital, Zurich

    lead OTHER

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2025-03-30
Completion
2025-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05128149 on ClinicalTrials.gov