Phase 4 Completed N=35 Randomized Quadruple-blind Treatment

Vitamin D Plus Fluticasone Propionate

Source: ClinicalTrials.gov NCT01103934 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcomePrimary: Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period — -11.3; -7.6 units on a scale — p=0.09

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period	-11.3; -7.6	0.09
SECONDARY Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period	-6.9; -3.7	0.04 sig

Eligibility Criteria

Inclusion Criteria

Males and females between 18 and 45 years of age.
History of tree, grass and/or ragweed allergic rhinitis.
Positive skin test to tree, grass and/or ragweed antigen.
Positive response to screening nasal challenge.

Exclusion Criteria

Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
Pregnant or lactating women.
Upper respiratory infection within 14 days of study start.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01103934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.