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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 20, 2012

Last Updated Date

July 30, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01560897 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Investigating Project of the Functional C13 Test "Pilot Study"

Official Title ^ICMJE

Investigating Project of the Functional C13 Test

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"

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Disorder of the Urea Cycle

Intervention ^ICMJE

Drug: Oral C13

Ingestion of C13 and follow up of the ureogenesis

Study Arm (s)

Experimental: C13

The dose of sodium [1-13C] acetate is calculated according to patient weight (27mg/kg) or (0.33 mmol / kg).

Intervention: Drug: Oral C13

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

healthy or with a disorder of the urea cycle

Exclusion Criteria:

Gender

Both

Ages

2 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Sokal Etienne, Professor

02 764 19 33

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01560897

Other Study ID Numbers ^ICMJE

Pilot Study

Has Data Monitoring Committee

Responsible Party

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Sponsor ^ICMJE

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top