Investigating Project of the Functional C13 Test "Pilot Study" (PIL001)

This study is currently recruiting participants.
Verified July 2012 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01560897
First received: March 20, 2012
Last updated: July 30, 2012
Last verified: July 2012
  Purpose

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"


Condition Intervention Phase
Disorder of the Urea Cycle
Drug: Oral C13
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Investigating Project of the Functional C13 Test

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Subject with a disorder of the urea cycle [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C13
The dose of sodium [1-13C] acetate is calculated according to patient weight (27mg/kg) or (0.33 mmol / kg).
Drug: Oral C13
Ingestion of C13 and follow up of the ureogenesis

  Eligibility

Ages Eligible for Study:   2 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy or with a disorder of the urea cycle

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560897

Contacts
Contact: Sokal Etienne, Professor 02 764 19 33

Locations
Belgium
Cliniques Saint Luc Recruiting
Brussels, Belgium
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  More Information

No publications provided

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01560897     History of Changes
Other Study ID Numbers: Pilot Study
Study First Received: March 20, 2012
Last Updated: July 30, 2012
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on April 17, 2014