Rhinitis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin D versus placebo
Cross-over design
Sponsors
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire. | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Associations between baseline serum vitamin D and subjects' demographics and treatment | 6 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety of vitamin D supplementation in the elderly | 6 weeks | Will assess serum vitamin D and calcium levels as well as possible side effects from the treatment as reported by the study subjects. No specific tool would be used. |
Countries
United States
Outcome results
None listed