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NCT01103934 · ClinicalTrials.gov registry record · Phase 4
Vitamin D Plus Fluticasone Propionate
A Phase 4 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 4
- Development phase
- 35
- Enrollment target
NCT01103934: Completed Phase 4 study, sponsored by University of Chicago.
NCT01103934 is a Phase 4 study that has completed, run by University of Chicago. The registered enrollment target is 35 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01103934, a Phase 4 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 35 participants
- Enrollment target
Study Summary
The objectives of this study would be to see if the addition of vitamin D to fluticasone propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis compared to fluticasone propionate treatment alone.
Primary Outcome
Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for
Interventions
- DRUG Placebo
- DRUG Vitamin D3
- DRUG Fluticasone Propionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
What the finished NCT01103934 record still lists
NCT01103934 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01103934 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01103934 about?
NCT01103934 is a clinical study titled "Vitamin D Plus Fluticasone Propionate". The objectives of this study would be to see if the addition of vitamin D to fluticasone propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis compared to fluticasone propionate treatment alone.
What is the current status of trial NCT01103934?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2010-06. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01103934?
The interventions under investigation include: Placebo (DRUG), Vitamin D3 (DRUG), Fluticasone Propionate (DRUG).
Who is sponsoring clinical trial NCT01103934?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01103934's enrollment target sits among peer trials
35 1506th of 2000 higher than 481 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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