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

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ClinicalTrials.gov Identifier: NCT01560897
Recruitment Status : Unknown
Verified July 2012 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : March 22, 2012
Last Update Posted : July 31, 2012
Sponsor:
Information provided by (Responsible Party):
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"

Condition or disease Intervention/treatment Phase
Disorder of the Urea Cycle Drug: Oral C13 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigating Project of the Functional C13 Test
Study Start Date : January 2012
Estimated Primary Completion Date : December 2012

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Subject with a disorder of the urea cycle [ Time Frame: Day 1 ]


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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:


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

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