Vitamin D Plus Fluticasone Propionate

The University of Chicago

Status and phase: Completed; Phase 4

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Vitamin D3; Drug: Placebo; Drug: Fluticasone Propionate

Study type: Interventional

Funder types: Other

Identifiers

NCT01103934

10-184-B

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

Exclusion Criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

Fluticasone Propionate plus Vitamin D3

Active Comparator group

Description:

Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season

Treatment:

Drug: Vitamin D3

Drug: Fluticasone Propionate

Fluticasone Propionate plus Placebo

Placebo Comparator group

Description:

Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season

Treatment:

Drug: Fluticasone Propionate

Drug: Placebo