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NCT Number: NCT02272101

Rhinitis in the Elderly: The Role of Vitamin D

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.

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Key information

Conditions

Rhinitis Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rohr and Columbo Asthma, Allergy and Immunology Specialists, Bryn Mawr, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D versus placebo

Dietary Supplement

Cross-over design

Primary outcomes

  1. Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire.

    Time frame: 6 weeks

Secondary outcomes

  1. Associations between baseline serum vitamin D and subjects' demographics and treatment

    Time frame: 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 outcomes

  1. Safety of vitamin D supplementation in the elderly

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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"

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 22, 2014
Registry last updated
Oct 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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