Rhinitis in the Elderly: The Role of Vitamin D

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

Status and phase: Completed; Phase 3

Conditions: Rhinitis

Treatments: Dietary Supplement: Vitamin D versus placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02272101

F/N-R14-3326B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

Vitamin D

Experimental group

Description:

Vitamin D 4,000 I.U. orally

Treatment:

Dietary Supplement: Vitamin D versus placebo

Placebo

Placebo Comparator group

Description:

Placebo orally

Treatment:

Dietary Supplement: Vitamin D versus placebo