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NCT01046773 · ClinicalTrials.gov registry record · Phase 1

Vitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's Disease

A Phase 1 study, sponsored by University of California, Los Angeles.

Terminated
Registry status
Phase 1
Development phase
3
Enrollment target

NCT01046773 is a Phase 1 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 3 participants.

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The verdict

NCT01046773, a Phase 1 study, was terminated before completion, sponsored by University of California, Los Angeles.

TERMINATED
Registry status
Phase 1
Development phase
3 participants
Enrollment target

Study Summary

IBD is caused by an abnormal immune response to the gut bacteria in people who are genetically predisposed. There has been a huge increase in the number of people diagnosed with IBD since World War II, likely due to changes in our environment. It is possible that the abundance of vitamin D in the body may be one of those environmental factors that the investigators can control to make patients with IBD better. Vitamin D acts on cells of the immune system and causes many effects, including the production of a "natural antibiotic" called cathelicidin. The investigators know that when people are supplemented with vitamin D, levels of cathelicidin produced by these immune cells increase. By supplementing children with Crohn's disease with vitamin D, the investigators may be able to alter their immune system "naturally," making their disease better. A consensus of vitamin D experts believes that vitamin D levels need to reach a level of 40-70 ng/mL in the blood in order to have effects on the immune system. Raising vitamin D levels to this range is one of the goals in the current study.

Interventions

  • DRUG Cholecalciferol

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2010-01
Est. Completion 2017-05
Phase Phase 1

What the Registry Record Tells You About NCT01046773

The ClinicalTrials.gov registry entry for NCT01046773 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Cholecalciferol is the first listed.

NCT01046773 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01046773 about?

NCT01046773 is a clinical study titled "Vitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's Disease". IBD is caused by an abnormal immune response to the gut bacteria in people who are genetically predisposed. There has been a huge increase in the number of people diagnosed with IBD since World War II, likely due to changes in our environment. It is possible that the abundance of vitamin D in the bo...

What is the current status of trial NCT01046773?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2010-01. Estimated completion is 2017-05.

What interventions are being tested in trial NCT01046773?

The interventions under investigation include: Cholecalciferol (DRUG).

Who is sponsoring clinical trial NCT01046773?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.