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Clinical Trials in the USA / NCT06953505
Recruiting Not applicable

At Home Ammonia Monitoring of Inborn Errors of Ammonia Metabolism

NCT06953505 · tracked via the Priya Life Science USA tracker
Sponsor
Sequitur Health Corp
Phase
Not applicable
Started
2025-09-23
Last updated
2026-05-27

Condition(s) studied

Urea Cycle DisordersOrganic AcidemiasFatty Acid Oxidation DisorderAmmonia; Metabolic Disorder

Investigational drug(s) / intervention(s)

Ammonia Study Device

Ammonia Study Device: Ammonia study device for capillary ammonia measurement

Study summary

The goal of this observational study is to learn if people with certain ammonia metabolism disorders will measure their ammonia levels at home.

The main question it aims to answer is:

• Will participants measure their ammonia every day?

Participants will be asked to:

* Attend two in-person study visits at the clinic.
* Measure temperature, heart rate, and blood oxygen every day.
* Complete a short survey every day.
* Measure ammonia every day.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Confirmed ammonia disorder such as * Ornithine transcarbamylase deficiency * Systemic primary carnitine deficiency * Type I citrullinemia * Argininosuccinic aciduria * Isolated methylmalonic acidemia * Type II citrullinemia * Propionic acidemia * Isovaleric acidemia * Multiple acyl-CoA dehydrogenase deficiency * Pyruvate carboxylase deficiency * Argininemia (arginase deficiency) * Carbamoyl phosphate synthase I deficiency * Dihydrolipoamide dehydrogenase deficiency * Lysinuric protein intolerance * Hyperornithinemia-hyperammonemia-homocitrullinuria * Carnitine-acylcarnitine translocase deficiency * Carbonic anhydrase VA deficiency * N-acetyl glutamate synthetase deficiency * English Literacy Exclusion Criteria: * Incarcerated * Presence of a non-inborn error of metabolism medical condition associated with abnormal ammonia metabolism (e.g., end stage liver disease). * Unable to read in English

Primary outcome measure(s)

  • Percentage of daily ammonia measurements completed. — through individual participant study completion - approximately 240 days per participant with an optional 120 day additional extension period available.
    Daily ammonia measurements will be completed on the ammonia study device. A single participant will have a single device. The device will store information about the time, date, and results from the measurements completed. The primary hypothesis is that participants will complete 90% of the daily ammonia measurements during their individual study periods.

Trial sites (1)

FacilityCityRegionStatus
Oregon Health & Science University Portland Oregon Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06953505 on ClinicalTrials.gov ↗ ← All trials in the USA