Rhinitis in the Elderly: The Role of Vitamin D

Study Overview
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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.

Official Title
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Rhinitis in the Elderly: A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study of the Effect of Vitamin D Supplementation on Nasal Symptoms and Rhinitis Related Quality of Life

Conditions
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Rhinitis

Intervention / Treatment
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* Dietary Supplement: Vitamin D versus placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>Vitamin D 4,000 I.U. orally | Dietary Supplement: Vitamin D versus placebo<br>* Cross-over design<br>|
| Placebo Comparator: Placebo<br>Placebo orally | Dietary Supplement: Vitamin D versus placebo<br>* Cross-over design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associations between baseline serum vitamin D and subjects' demographics and treatment | Demographics include age, body mass index, duration of rhinitis, and presence of asthma. Treatment include drugs utilized for treatment of rhinitis expressed as total medication score. | 6 weeks |