Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02511041 · ClinicalTrials.gov registry record · Phase 1
Immunologic Effects of Supplemental Monosaccharide and Nucleoside Derivatives in Patients With Inherited Disorders of Glycosylation
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02511041 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2 participants.
The verdict
NCT02511041, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: \- A congenital disorder of glycosylation (CDG) affects the cells that make up the organs and tissues. In these cells, sugar molecules do not properly attach to other molecules, which are the basic building blocks of cells. Changes in sugars seen in people with CDGs may lead to allergies and can change people s ability to fight infections. Researchers want to see if a sugar supplement called N-acetylglucosamine can help people with CDGs who have detectable changes in their immune systems. Objective: \- To see if N-acetylglucosamine can help cells to function in a healthy way in people with CDGs. Eligibility: \- People at least 2 years of age who have a CDG and immune system changes. Design: * Participants will be screened with a physical exam, medical history, and blood tests. * One month later, participants will repeat the blood tests from the screening visit. Blood will be drawn on 2 different days in the same week. * Participants will get N-acetylglucosamine supplements and instructions for how to take them. N-acetylglucosamine is a powder that can be added to food or drink. * Participants will have a physical exam and blood tests every month during the study. * After taking N-acetylglucosamine for about 4 months, participants will have more blood tests. They will get more N-acetylglucosamine supplements and a nucleoside supplement. The second supplement may be a powder or tablets that may be crushed and added to food. Participants will take both supplements for 5 months. * After about 10 months in the study, participants will have 2 more visits in the same week for the same blood tests.
Interventions
- DRUG Uridine
- DRUG N-Acetylglucosamine (GlcNAc)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-06-30 |
| Est. Completion | 2017-01-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02511041
The ClinicalTrials.gov registry entry for NCT02511041 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Uridine is the first listed.
NCT02511041 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02511041 about?
NCT02511041 is a clinical study titled "Immunologic Effects of Supplemental Monosaccharide and Nucleoside Derivatives in Patients With Inherited Disorders of Glycosylation". Background: \- A congenital disorder of glycosylation (CDG) affects the cells that make up the organs and tissues. In these cells, sugar molecules do not properly attach to other molecules, which are the basic building blocks of cells. Changes in sugars seen in people with CDGs may lead to allergie...
What is the current status of trial NCT02511041?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2015-06-30. Estimated completion is 2017-01-24.
What interventions are being tested in trial NCT02511041?
The interventions under investigation include: Uridine (DRUG), N-Acetylglucosamine (GlcNAc) (DRUG).
Who is sponsoring clinical trial NCT02511041?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.