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:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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
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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 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 May 22, 2013