Investigating Project of the Functional C13 Test "Pilot Study"

Phase 1

• Conditions: Disorder of the Urea Cycle
• Interventions: Drug: Oral C13

• Registration Number: NCT01560897
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-30
• Last Update Posted: 2012-07-31
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• healthy or with a disorder of the urea cycle

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C13	Oral C13	The dose of sodium \[1-13C\] acetate is calculated according to patient weight (27mg/kg) or (0.33 mmol / kg).

Primary Outcome Measures

Name	Time	Method
Subject with a disorder of the urea cycle	Day 1

Trial Locations

Locations (1)

Cliniques Saint Luc; 🇧🇪 Brussels, Belgium