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

NCT ID: NCT04210206

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Phenylketonurias

Keywords

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cognitive function adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diet

Group Type EXPERIMENTAL

PHE-diet

Intervention Type OTHER

phenylalanine-restricted diet with phenylalanine free supplements for 8 weeks

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PHE-diet

phenylalanine-restricted diet with phenylalanine free supplements for 8 weeks

Intervention Type OTHER

Eligibility Criteria

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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

* Reduced cognitive function (unability to perform test battery)
* Drug and or alcohol abuse
* Treatment with BH4
* Treatment with drugs known to affect cognitive function
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klaus Parhofer

OTHER

Sponsor Role lead

Responsible Party

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Klaus Parhofer

Professor of Endocrinology and Metabolism

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University Munich

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CoFu-PKU

Identifier Type: -

Identifier Source: org_study_id