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Study in Healthy Subjects, Patients With Urea Cycle Disorders (UCD) and Carriers of UCD Mutations to Evaluate Urea Cycle Function

NCT01549015 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2013-06-26

No results posted yet for this study

Summary

This diagnostic study will be performed to investigate the performance of the urea cycle in healthy subjects, asymptomatic carriers of Urea Cycle Disorders (UCD) mutations and subjects with genetically proven urea cycle disorders. The ureagenesis rate will be measured by 13C incorporation assay, a method for in vivo measurement of urea cycle performance with stable isotopes.

Conditions

  • Urea Cycle Disorders

Interventions

OTHER

oral administration of Sodium [1,2-13C]-Acetate

single dose of 0.55 mg/kg 13C-Acetate given orally of via a naso-gastric tube

Sponsors & Collaborators

  • CRS Clinical Research Services Mannheim GmbH

    collaborator INDUSTRY

  • Cytonet GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Georg F Hoffmann, Prof Dr med · Universitätsklinikum Heidelberg Klinik für Kinderheilkunde I

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-07-31
Completion
2013-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01549015 on ClinicalTrials.gov