Rhinitis in the Elderly: The Role of Vitamin D

NCT ID: NCT02272101

Last Updated: 2014-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-03-31

Brief Summary

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A study of the role of vitamin D in elderly subjects with perennial and/or nonallergic rhinitis. The hypothesis is that vitamin D supplementation will improve rhinitis symptoms and rhinitis related quality of life.

Detailed Description

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Rhinitis in the elderly is poorly understood as this group of patients has been ignored in almost all rhinitis studies. Vitamin D deficiency and insufficiency are very common, especially in the elderly. Vitamin D may play an important role in respiratory disease as shown by studies in asthma. This is a randomized, double-blind, placebo controlled, cross-over study. The investigators will look for the effect of vitamin D 4,000 I.U/day vs. placebo for six weeks on symptom scores and rhinitis related quality of life. This study will be performed in the period Nov. 1, 2013 and March 31, 2014, to try to avoid seasonal fluctuations of serum vitamin D due to sun exposure. The investigators will also look for possible associations between serum vitamin D at baseline and study subjects demographics, treatment, and symptom scores.

Conditions

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Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D

Vitamin D 4,000 I.U. orally

Group Type EXPERIMENTAL

Vitamin D versus placebo

Intervention Type DIETARY_SUPPLEMENT

Cross-over design

Placebo

Placebo orally

Group Type PLACEBO_COMPARATOR

Vitamin D versus placebo

Intervention Type DIETARY_SUPPLEMENT

Cross-over design

Interventions

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Vitamin D versus placebo

Cross-over design

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Subjects 65 years old and older with perennial and/or nonallergic rhinitis

Exclusion Criteria

* Current smokers, digoxin, liver disease, anticoagulants (except for aspirin), planning a surgical procedure during the study period.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

OTHER

Sponsor Role lead

Responsible Party

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Michele Columbo, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michele Columbo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rohr and Columbo Associates

Locations

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Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

Bryn Mawr, Pennsylvania, United States

Site Status

Rohr and Columbo Asthma, Allergy and Immunology Specialists

Bryn Mawr, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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F/N-R14-3326B

Identifier Type: -

Identifier Source: org_study_id

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