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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: Clinical Trial Phase 1 study, sponsored by University of California, Los Angeles.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-01 |
| Est. Completion | 2017-05 |
| Phase | Phase 1 |
Why NCT01046773 stopped before completion
NCT01046773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Cholecalciferol is the first listed.
NCT01046773 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01046773's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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