Vitamin D Plus Fluticasone Propionate

NCT ID: NCT01103934

Last Updated: 2014-10-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fluticasone Propionate plus Vitamin D3

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

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DRUG

4000 IU once daily

Fluticasone Propionate

Intervention Type DRUG

200 mcg daily, intranasal

Fluticasone Propionate plus Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo taken once daily

Fluticasone Propionate

Intervention Type DRUG

200 mcg daily, intranasal

Interventions

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Vitamin D3

4000 IU once daily

Intervention Type DRUG

Placebo

Placebo taken once daily

Intervention Type DRUG

Fluticasone Propionate

200 mcg daily, intranasal

Intervention Type DRUG

Other Intervention Names

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Flonase

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert M Naclerio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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10-184-B

Identifier Type: -

Identifier Source: org_study_id

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