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At Home Ammonia Monitoring of Inborn Errors of Ammonia Metabolism

NCT06953505 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-06

No results posted yet for this 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 three 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

Interventions

DIAGNOSTIC_TEST

Ammonia Study Device

Ammonia study device for capillary ammonia measurement

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Oregon Health and Science University

    collaborator OTHER

  • Sequitur Health Corp.

    lead INDUSTRY

Principal Investigators

  • Marylaura L Thomas, Ph.D. · Sequitur Health Corp.

  • Leslie F. Thomas, M.D. · Sequitur Health Corp.

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-23
Primary Completion
2027-07-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States

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 NCT06953505 on ClinicalTrials.gov