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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560897
First Posted: March 22, 2012
Last Update Posted: July 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  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: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy or with a disorder of the urea cycle

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01560897     History of Changes
Other Study ID Numbers: Pilot Study
First Submitted: March 20, 2012
First Posted: March 22, 2012
Last Update Posted: July 31, 2012
Last Verified: July 2012