NCT01002469

Brief Summary

In this short-term study a method for the evaluation of the metabolic competency of the urea cycle in vivo will be assessed. In order to monitor the efficacy of new treatment options for patients with urea cycle disorders and to monitor the severity of the disease, a reliable and safe quantitative method for the measurement of the urea cycle flux is required. Urea synthesis will be evaluated by administering sodium \[1-13C\]-acetate and measuring subsequent incorporation of \[13C\] label from Na-acetate into urea in healthy volunteers and asymptomatic subjects genetically disposed to urea cycle disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

2 months

First QC Date

October 26, 2009

Last Update Submit

January 14, 2010

Conditions

Urea Cycle Disorders

Keywords

isotope ratio measurementurea cycle13C acetateHealthy adults

Outcome Measures

Primary Outcomes (1)

  • Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline

Secondary Outcomes (1)

  • Cmax of absolute [13C]urea in plasma

Study Arms (1)

sodium [1-13C] acetate

EXPERIMENTAL
Other: sodium [1-13C] acetate

Interventions

sodium [1-13C] acetateOTHER
sodium [1-13C] acetate

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Group 1 + 2: Healthy subjects
  • Group 3: Healthy asymptomatic subjects genetically disposed to urea cycle disorders
  • All: age 18 to 50 years (adult)
  • Written informed consent

You may not qualify if:

  • Presence of acute infection
  • Severe coagulopathy
  • Severe systemic or chronic disease
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRS Clinical Research Services Mönchengladbach GmbH

Mönchengladbach, 41061, Germany

Location

MeSH Terms

Conditions

Urea Cycle Disorders, Inborn

Interventions

SodiumAcetates

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetalsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Doris Neuenhofer, MD

    CRS Clinical Research Services Mönchengladbach GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

September 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

DE(1)