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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Disorder of the Urea Cycle

Treatments: Drug: Oral C13

Study type: Interventional

Funder types: Other

Identifiers

NCT01560897

Pilot Study

Details and patient eligibility

About

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"

Enrollment: 10 estimated patients

Sex: All

Ages: 2 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• healthy or with a disorder of the urea cycle

Exclusion Criteria:

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

C13

Experimental group

Description:

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

Treatment:

Drug: Oral C13