Investigating Project of the Functional C13 Test "Pilot Study"

Disorder of the Urea Cycle Clinical Trial

— PIL001  

Official title:

Investigating Project of the Functional C13 Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01560897
• Other study ID #: Pilot Study
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 20, 2012
• Last updated: July 30, 2012
• Start date: January 2012

Study information

• Verified date: July 2012
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Sokal Etienne, Professor
• Phone: 02 764 19 33
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy or with a disorder of the urea cycle

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Disorder of the Urea Cycle

Intervention

Drug:
• Oral C13
Ingestion of C13 and follow up of the ureogenesis

Locations

Country	Name	City	State
Belgium	Cliniques Saint Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject with a disorder of the urea cycle		Day 1	No