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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014