Recruiting

Observational Study

Sponsor:

Sequitur Health Corp.

Code:

NCT06953505

Conditions

Urea Cycle Disorders

Organic Acidemias

Fatty Acid Oxidation Disorder

Ammonia; Metabolic Disorder

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Ammonia Study Device

Study Details

Brief 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.

Conditions

Urea Cycle Disorders

Organic Acidemias

Fatty Acid Oxidation Disorder

Ammonia; Metabolic Disorder

Study ID

NCT06953505

Start date

Sep 23, 2025

Status verified date

May, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Ammonia Device

Interventions

Ammonia Study Device

Ammonia study device for capillary ammonia measurement

Primary outcome measure

  • Percentage of daily ammonia measurements completed. [ Time Frame: through individual participant study completion - approximately 240 days per participant with an optional 120 day additional extension period available. ]

Central Contacts and Locations

Central contacts

Marylaura Thomas, Ph.D.

1-855-445-3889info@sequiturhealth.com

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239-3098

Contacts

Amy C. Yang, M.D.

503-494-8307

Principal Investigator:

Amy C Yang, M.D.

More Information

Sponsor

Sequitur Health Corp.

Last update posted

May 27, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sequitur Health Corp. on 2026-05-27.