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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: Clinical Trial Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 2 participants
Start Date 2015-06-30
Est. Completion 2017-01-24
Phase Phase 1

Why NCT02511041 stopped before completion

NCT02511041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Uridine is the first listed.

NCT02511041 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02511041's enrollment target sits among peer trials

2 2000th of 2000 the lowest of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02511041, the US trial registry maintained by the National Library of Medicine. NCT02511041 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.