A Phase 4 interventional study of Vitamin D3 and Placebo in Seasonal Allergic Rhinitis, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2014-10-09.
Sponsored by University of Chicago · Phase 4, Interventional, and Treatment
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 35 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
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Exclusion Criteria
Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season
Drug: Vitamin D3 · Drug: Fluticasone Propionate
Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
Drug: Placebo · Drug: Fluticasone Propionate
4000 IU once daily
Placebo taken once daily
200 mcg daily, intranasal
Also known as: Flonase
Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period
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 each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms.
Time frame: Baseline and 2 weeks
Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period
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 DNSS was calculated as the sum of all scores for morning with a range of 0 to 12. 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 each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in daytime symptoms.
Time frame: Baseline and 2 weeks
| Milestone | Fluticasone Propionate Plus Vitamin D3 | Fluticasone Propionate Plus Placebo |
|---|---|---|
| Started | 17 | 18 |
| Completed | 17 | 18 |
| Not completed | 0 | 0 |
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 each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms.
| units on a scale | Fluticasone Propionate Plus Vitamin D3 | Fluticasone Propionate Plus Placebo |
|---|---|---|
| Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period | -11.3 (-18.9 to 8.8) | -7.6 (-18.7 to 0.7) |
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 DNSS was calculated as the sum of all scores for morning with a range of 0 to 12. 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 each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in daytime symptoms.
| units on a scale | Fluticasone Propionate Plus Vitamin D3 | Fluticasone Propionate Plus Placebo |
|---|---|---|
| Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period | -6.9 (-10.2 to 5.2) | -3.7 (-10.6 to -0.2) |
Collected over 2 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluticasone Propionate Plus Vitamin D3 | — | 0/17 (0%) | 0/17 (0%) |
| Fluticasone Propionate Plus Placebo | — | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(years) | Fluticasone Propionate Plus Vitamin D3 | Fluticasone Propionate Plus Placebo | Total |
|---|---|---|---|
| Mean | 27.3 ± 6.1 | 29.5 ± 9.3 | 28.4 ± 7.9 |
| Sex: Female, Male(Participants) | Fluticasone Propionate Plus Vitamin D3 | Fluticasone Propionate Plus Placebo | Total |
|---|---|---|---|
| Female | 10 | 9 | 19 |
| Male | 7 | 9 | 16 |
| Region of Enrollment(participants) | Fluticasone Propionate Plus Vitamin D3 | Fluticasone Propionate Plus Placebo | Total |
|---|---|---|---|
| United States | 17 | 18 | 35 |
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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University of Chicago