Analyzing urea production in healthy individuals and patients with urea cycle disorders
Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients
NA · University Children's Hospital, Zurich · NCT05671666
This study is testing how well the body makes urea in healthy people and those with urea cycle disorders to better understand these conditions and improve treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich (other) |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT05671666 on ClinicalTrials.gov |
What this trial studies
This study focuses on measuring ureagenesis, the production of urea, in both healthy subjects and patients diagnosed with urea cycle disorders (UCDs). By utilizing a stable ammonium chloride isotope as a tracer, researchers aim to evaluate the overall function of the urea cycle, which is crucial for assessing the efficacy of current and future therapies for UCDs. The study seeks to provide a more comprehensive understanding of UCDs compared to traditional methods that analyze individual metabolites or enzymes. Participants will include healthy individuals and UCD patients who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals of any age and patients with a confirmed diagnosis of urea cycle disorders.
Not a fit: Patients with acute or chronic diseases requiring treatment, as well as pregnant or lactating women, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved evaluation methods for novel therapies targeting urea cycle disorders.
How similar studies have performed: While the approach of measuring ureagenesis is innovative, similar studies have not been widely reported, indicating this may be a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * healthy subjects at any age and given written informed consent * subjects with a UCD confirmed by genetic or enzymatic diagnostics at any age and given written informed consent Exclusion Criteria: * healthy subjects with acute and chronic disease requiring treatment of any kind * pregnant or lactating women. * UCD patients with acute and chronic (other than her/his UCD) disease requiring treatment * UCD patients in which intake of carglumic acid cannot be stopped for 24 hours prior to the test
Where this trial is running
Zurich, Canton of Zurich
- University Children's Hospital — Zurich, Canton of Zurich, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Johannes Häberle
- Email: Johannes.haeberle@kispi.uzh.ch
- Phone: 0041-442495988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urea Cycle Disorders