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Phenylalanine and Its Impact on Cognition

NCT03788343 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-03-07

No results posted yet for this study

Summary

The PICO-Study is a randomized, placebo-controlled, crossover, non-inferiority trial conducted to add evidence to the current European treatment guidelines for adult patients with phenylketonuria.

Conditions

Interventions

DIETARY_SUPPLEMENT

Phenylalanine

The study product Phenylalanine, a dietary supplement, is authorized in Switzerland, but not designated for this patient group.

DRUG

Placebo

Placebo capsules are indistinguishable in their appearance from Phe capsules

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Regula Everts, Prof. Dr. phil. · Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-19
Primary Completion
2022-06-17
Completion
2022-06-17

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03788343 on ClinicalTrials.gov