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Rhinitis in the Elderly: The Role of Vitamin D

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ClinicalTrials.gov Identifier: NCT02272101
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Michele Columbo, M.D., Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

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.

Condition or disease Intervention/treatment Phase
Rhinitis Dietary Supplement: Vitamin D versus placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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




Primary Outcome Measures :
  1. Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272101


Locations
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United States, Pennsylvania
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Bryn Mawr, Pennsylvania, United States, 19010
Rohr and Columbo Asthma, Allergy and Immunology Specialists
Bryn Mawr, Pennsylvania, United States, 19010
Sponsors and Collaborators
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Investigators
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Principal Investigator: Michele Columbo, M.D. Rohr and Columbo Associates

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Responsible Party: Michele Columbo, M.D., Principal Investigator, Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
ClinicalTrials.gov Identifier: NCT02272101    
Other Study ID Numbers: F/N-R14-3326B
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents