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

Study acronym: PKU_Guide
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Dec 31, 2024 to Mar 30, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v7
  2. Primary completion date: Jun 30, 2024 to Dec 31, 2024v6
  3. Primary completion date: Sep 30, 2023 to Jun 30, 2024
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    v5
  4. Primary completion date: Feb 28, 2023 to Sep 30, 2023
    • Study completion date: Feb 28, 2023 to Dec 31, 2023
    v4
  5. Primary completion date: Oct 2022 to Feb 28, 2023
    • Study completion date: Nov 2022 to Feb 28, 2023
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05128149
Lead Sponsor University Children's Hospital, Zurich
Collaborators: UChildrenVienna, University Children's Hospital Basel, Insel Gruppe AG, University Hospital Bern
Conditions
(from sponsor)		 Phenylketonurias
Related terms Phenylketonurias
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov