Rhinitis in the Elderly: The Role of Vitamin D

October 21, 2014 updated by: Michele Columbo, M.D., Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

"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"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Rohr and Columbo Asthma, Allergy and Immunology Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D
Vitamin D 4,000 I.U. orally
Dietary supplement: Vitamin D versus placebo
Cross-over design
Placebo Comparator: Placebo
Placebo orally
Dietary supplement: Vitamin D versus placebo
Cross-over design

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire.
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Michele Columbo, M.D., Rohr and Columbo Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Estimate)

October 22, 2014

Last Update Submitted That Met QC Criteria

October 21, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F/N-R14-3326B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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