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TerminatedNCT04210206Updated Dec 14, 2023

Short-term Effects of Good Metabolic Control on Cognitive Function, Wellbeing, and Metabolic Parameters in Adult Patients With Phenylketonuria

An interventional study of PHE-diet in Phenylketonurias, sponsored by Klaus Parhofer. Terminated at 1 site in Germany. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by Klaus Parhofer · Not applicable, Interventional, and Treatment

Why this study was terminated
Recruitment failure
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study summary

The goal of this study is to evaluate if in adult patients with phenylketonuria (PKU) without strict metabolic control during the last 12 months, strict metabolic control for 8 weeks results in an improvement of cognitive function.

02

Conditions studied

  • Phenylketonurias

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Keywords

  • cognitive function adults
03

In context

Phenylketonurias

183 studies on the registry are indexed under Phenylketonurias; 38 are open to participants now.

This study's enrollment of 13 is below the median of 25 across 114 interventional studies indexed under Phenylketonurias.

Browse Phenylketonurias studies →

Lead sponsor

This is the only study on the registry with Klaus Parhofer as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men and women with classical PKU
  • Age ≥ 18 years
  • Good metabolic control during childhood (at least until 12 years of age)
  • Plasma Phe levels ≥ 15 mg/dl for ≥ 1 year
  • Written informed consent prior to study participation

Exclusion criteria

Exclusion Criteria:

  • Reduced cognitive function (unability to perform test battery)
  • Drug and or alcohol abuse
  • Treatment with BH4
  • Treatment with drugs known to affect cognitive function
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Diet

    Other: PHE-diet

  • No intervention
    Control

Interventions

  • OtherPHE-diet

    phenylalanine-restricted diet with phenylalanine free supplements for 8 weeks

06

What researchers measure

Primary outcomes

  1. Spatial working memory strategy index

    cognitive function; scores range from 4 to 28, with lower scores representing better outcome

    Time frame: 8 weeks

Secondary outcomes

  1. Reaction time

    cognitive function; milliseconds, with faster times representing better outcome

    Time frame: 8 weeks

  2. Paired Associates Learning

    cognitive function; scores range from 0 to 70, with lower scores indicating better outcome

    Time frame: 8 weeks

  3. Multitasking Test

    cognitive function; scores range from 0 to 279, with lower scores indicating better outcome

    Time frame: 8 weeks

07

Study locations

1 site
  • University Munich
    Munich, 81377, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04210206
Lead sponsor
Klaus Parhofer
Responsible party
Klaus Parhofer (Professor of Endocrinology and Metabolism, Ludwig-Maximilians - University of Munich) — Sponsor-investigator
First posted
Dec 24, 2019
Start date
Dec 1, 2019
Primary completion
Aug 31, 2023
Completion
Aug 31, 2023
Last update
Dec 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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