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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 September 2019
Main ID:  NCT03788343
Date of registration: 17/12/2018
Prospective Registration: Yes
Primary sponsor: University Hospital Inselspital, Berne
Public title: Phenylalanine and Its Impact on Cognition PICO
Scientific title: PICO: Phenylalanine and Its Impact on Cognition - Impact of Phenylalanine on Cognitive, Cerebral and Neurometabolic Parameters in Adult Patients With Phenylketonuria
Date of first enrolment: August 19, 2019
Target sample size: 60
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03788343
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Investigator).  
Phase:  Phase 4
Countries of recruitment
Switzerland
Contacts
Name:     Regula Everts, Prof. Dr. phil.
Address: 
Telephone: +41 31 632 41 30
Email: regula.everts@insel.ch
Affiliation: 
Name:     Raphaela Muri, MSc
Address: 
Telephone: +41 31 632 47 42
Email: raphaela.muri@insel.ch
Affiliation: 
Name:     Regula Everts, Prof. Dr. phil.
Address: 
Telephone:
Email:
Affiliation:  Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital
Key inclusion & exclusion criteria

PATIENTS

Inclusion Criteria:

- PKU diagnosed after a positive newborn screening

- Treatment with Phe-restricted diet starting within the first 30 days of life

- Age =18 years

- Capable of following the study design

- Written informed consent

Exclusion Criteria:

- Patients with PKU not following a Phe-restricted diet within 6 months before the study

- Phe concentration above 1600 ┬Ámol/L within 6 months before the study

- Concomitant disease states suspected to significantly affect primary or secondary
outcomes, e. g. untreated vitamin B12 deficiency

- Known or suspected non-compliance, drug or alcohol abuse

- Change in medications likely to significantly interfere with cognitive function
testing

- Known or suspected hypersensitivity or allergy to one of the ingredients of the
placebo

- Women who are pregnant or intent to get pregnant during the course of the study or who
are breast feeding

- Female participants of childbearing potential, not using and not willing to continue
using one (or more) highly efficient (Pearl index less than 1) method of contraception
for the entire study duration.

- Inability to follow the procedures of the study, e. g. due to language problems (lack
of fluency in German or French), psychological disorders, dementia, etc. of the
participant.

- Participation in another interventional study within the 30 days preceding and during
the present study.

- Previous enrolment into the current study

- Conditions interfering with MRI such as magnetic (metallic) particles in the skull or
brain, cardiac pacemaker, deep brain stimulators, cochlear implant, braces or
permanent retainers

HEALTHY CONTROLS

Inclusion Criteria:

- Age =18 years

- Comparable to patients with regard to age, gender and educational level

- Capable of following the study design

- Written informed consent

Exclusion Criteria:

- Known or suspected drug or alcohol abuse

- Change in medications likely to significantly interfere with cognitive function
testing

- Women who are pregnant or intent to get pregnant during the course of the study or who
are breast feeding

- Inability to follow the procedures of the study, e. g. due to language problems (lack
of fluency in German or French), psychological disorders, dementia, etc. of the
participant.

- Participation in another interventional study within the 30 days preceding and during
the present study.

- Previous enrolment into the current study

- Conditions interfering with MRI such as magnetic (metallic) particles in the skull or
brain, cardiac pacemaker, deep brain stimulators, cochlear implant, braces or
permanent retainers



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Phenylketonuria
Intervention(s)
Dietary Supplement: Phenylalanine
Drug: Placebo
Primary Outcome(s)
Working memory (accuracy) [Time Frame: After intervention phase 1 (after 4 weeks from baseline)]
Working memory (accuracy) [Time Frame: After intervention phase 2 (after 12 weeks from baseline)]
Secondary Outcome(s)
Cognitive flexibility [Time Frame: 4 times: baseline, after intervention phase 1 (4 weeks from baseline), after washout (8 weeks from baseline), after intervention phase 2 (12 weeks from baseline)]
Functional Magnetic Resonance Imaging (fMRI) (working memory) [Time Frame: 4 times: baseline, after intervention phase 1 (4 weeks from baseline), after washout (8 weeks from baseline), after intervention phase 2 (12 weeks from baseline)]
Inhibition [Time Frame: 4 times: baseline, after intervention phase 1 (4 weeks from baseline), after washout (8 weeks from baseline), after intervention phase 2 (12 weeks from baseline)]
Magnetic Resonance Spectroscopy (MRS) [Time Frame: 4 times: baseline, after intervention phase 1 (4 weeks from baseline), after washout (8 weeks from baseline), after intervention phase 2 (12 weeks from baseline)]
Resting-state fMRI [Time Frame: 4 times: baseline, after intervention phase 1 (4 weeks from baseline), after washout (8 weeks from baseline), after intervention phase 2 (12 weeks from baseline)]
Working memory (reaction time) [Time Frame: 4 times: baseline, after intervention phase 1 (4 weeks from baseline), after washout (8 weeks from baseline), after intervention phase 2 (12 weeks from baseline)]
Secondary ID(s)
2018-01609
3837
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Zurich
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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