Rhinitis in the Elderly: The Role of Vitamin D

Rhinitis Clinical Trial

Official title:

"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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272101
• Other study ID #: F/N-R14-3326B
• Status: Completed
• Phase: Phase 3
• First received: December 12, 2013
• Last updated: October 21, 2014
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: October 2014
• Source: Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis

Intervention

Dietary Supplement:
• Vitamin D versus placebo
Cross-over design

Locations

Country	Name	City	State
United States	Rohr and Columbo Asthma, Allergy and Immunology Specialists	Bryn Mawr	Pennsylvania
United States	Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.	Bryn Mawr	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of vitamin D supplementation in the elderly	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.	6 weeks	Yes
Primary	Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire.		6 weeks	No
Secondary	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	No