Rhinitis in the Elderly: The Role of Vitamin D
Primary Purpose
Rhinitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vitamin D versus placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis
Eligibility Criteria
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.
Sites / Locations
- Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
- Rohr and Columbo Asthma, Allergy and Immunology Specialists
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D
Placebo
Arm Description
Vitamin D 4,000 I.U. orally
Placebo orally
Outcomes
Primary Outcome Measures
Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02272101
First Posted
December 12, 2013
Last Updated
October 21, 2014
Sponsor
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
1. Study Identification
Unique Protocol Identification Number
NCT02272101
Brief Title
Rhinitis in the Elderly: The Role of Vitamin D
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"
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
Vitamin D 4,000 I.U. orally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo orally
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D versus placebo
Intervention Description
Cross-over design
Primary Outcome Measure Information:
Title
Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Associations between baseline serum vitamin D and subjects' demographics and treatment
Description
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.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Safety of vitamin D supplementation in the elderly
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Columbo, M.D.
Organizational Affiliation
Rohr and Columbo Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Rohr and Columbo Asthma, Allergy and Immunology Specialists
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Rhinitis in the Elderly: The Role of Vitamin D
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