CClinicalTrials.gg
Status unknownNCT01560897PIL001Updated Jul 31, 2012

Investigating Project of the Functional C13 Test "Pilot Study"

A Phase 1/2 interventional study of Oral C13 in Disorder of the Urea Cycle, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Status unknown at 1 site in Belgium. Open to participants aged 2 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-31.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Phase 1/2, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
2 Years to 50 Years
Sex
All
01

Study 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"

02

Conditions studied

  • Disorder of the Urea Cycle
03

In context

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy or with a disorder of the urea cycle

Exclusion criteria

Exclusion Criteria:

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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

Interventions

  • DrugOral C13

    Ingestion of C13 and follow up of the ureogenesis

06

What researchers measure

Primary outcomes

  1. Subject with a disorder of the urea cycle

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
  • Cliniques Saint Luc
    Brussels, Belgium
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01560897
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
Mar 22, 2012
Start date
Jan 2012
Primary completion
Dec 2012 (estimated)
Last update
Jul 31, 2012

Study contacts

Sokal Etienne, Professor
Contact
02 764 19 33

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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