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Investigating Project of the Functional C13 Test "Pilot Study"

NCT ID: NCT01560897

Last Updated: 2012-07-31

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

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Brief Summary

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The aim of this pilot study is to evaluate the validity and reproducibility of a functional test "Test C13" ureogenesis to measure in vivo, using the methodology Laboratory of Metabolic Diseases of "Cliniques Universitaires Saint-Luc"

Detailed Description

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Conditions

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Disorder of the Urea Cycle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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C13

The dose of sodium \[1-13C\] acetate is calculated according to patient weight (27mg/kg) or (0.33 mmol / kg).

Group Type EXPERIMENTAL

Oral C13

Intervention Type DRUG

Ingestion of C13 and follow up of the ureogenesis

Interventions

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Oral C13

Ingestion of C13 and follow up of the ureogenesis

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy or with a disorder of the urea cycle
Minimum Eligible Age

2 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cliniques Saint Luc

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Sokal Etienne, Professor

Role: CONTACT

Phone: 02 764 19 33

Other Identifiers

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Pilot Study

Identifier Type: -

Identifier Source: org_study_id