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NCT01921894 · ClinicalTrials.gov registry record · Phase 1
Vitamin D and Severe Asthma Exacerbations
A Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01921894: Completed Phase 1 study, sponsored by University of Pittsburgh.
NCT01921894 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01921894, a Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This study of vitamin D is designed to assess both the safety and efficacy of potential doses (2,000 IU/day and 4,000 IU/day) in raising a vitamin D level to a normal range in a short period of time (e.g. 4 weeks or less) compared to 200 IU/day. In children with vitamin D insufficiency or deficiency who are at risk for severe asthma exacerbations, we hypothesize that both vitamin D supplementation with 4,000 IU/day and 2,000 IU/day will safely achieve normal vitamin D levels, but that the higher dose (4,000 IU/day) will result in a larger proportion of subjects achieving this level at 4 and 8 weeks.
Primary Outcome
The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
Interventions
- DIETARY_SUPPLEMENT Cholecalciferol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT01921894 record still lists
NCT01921894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 1 intervention - of which Cholecalciferol is the first listed.
NCT01921894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01921894 about?
NCT01921894 is a clinical study titled "Vitamin D and Severe Asthma Exacerbations". This study of vitamin D is designed to assess both the safety and efficacy of potential doses (2,000 IU/day and 4,000 IU/day) in raising a vitamin D level to a normal range in a short period of time (e.g. 4 weeks or less) compared to 200 IU/day. In children with vitamin D insufficiency or deficienc...
What is the current status of trial NCT01921894?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2013-08. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01921894?
The interventions under investigation include: Cholecalciferol (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01921894?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01921894's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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