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

Investigating Project of the Functional C13 Test

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"

Study Overview

• Status: Unknown
• Conditions: Disorder of the Urea Cycle
• Intervention / Treatment: Drug: Oral C13

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Sokal Etienne, Professor; Phone Number: 02 764 19 33

Study Locations

• Belgium
  • Brussels, Belgium
    • Recruiting
    • Cliniques Saint Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy or with a disorder of the urea cycle

Exclusion Criteria:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subject with a disorder of the urea cycle	Day 1

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: March 20, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Estimate): July 31, 2012
• Last Update Submitted That Met QC Criteria: July 30, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: Pilot Study