"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"
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Vitamin D
Vitamin D 4,000 I.U. orally
Intervention: Vitamin D versus placebo (Dietary Supplement)
Placebo
Placebo orally
Intervention: Vitamin D versus placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire.
Time Frame: 6 weeks
Secondary Outcomes
- Associations between baseline serum vitamin D and subjects' demographics and treatment(6 weeks)
Investigators
Michele Columbo, M.D.
Principal Investigator
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.