RhinitisPhase 3NCT02272101
Rhinitis in the Elderly: The Role of Vitamin D
A Phase 3 study of Rhinitis, run by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Rhinitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2013to Mar 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects 65 years old and older with perennial and/or nonallergic rhinitis
Who cannot join
- Current smokers, digoxin, liver disease, anticoagulants (except for aspirin), planning a surgical procedure during the study period.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Bryn Mawr, Pennsylvania, 19010
Rohr and Columbo Asthma, Allergy and Immunology Specialists
Bryn Mawr, Pennsylvania, 19010
About this study
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"
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.
Read the 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.
- Conditions
- Rhinitis
- Being tested
- Vitamin D versus placebo
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D versus placeboDietary supplement
Cross-over design
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Vitamin D 4,000 I.U. orally Receives: Dietary Supplement: Vitamin D versus placebo |
| Placebo | Placebo comparator | Placebo orally Receives: Dietary Supplement: Vitamin D versus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire.
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Columbo, M.D., Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
- Investigators
- Michele Columbo, M.D., Principal investigator, Rohr and Columbo Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272101
- Sponsor's protocol ID
- F/N-R14-3326B
- Status last verified
- Oct 2014
- First submitted
- 12 Dec 2013
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT02272101
- Acronym / sponsor ID
- F/N-R14-3326B
- Conditions
- Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.University, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Dietary Supplement: Vitamin D versus placeboVitamin D 4,000 I.U. orally |
| Placebo | Placebo comparator | Dietary Supplement: Vitamin D versus placeboPlacebo orally |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Subjects 65 years old and older with perennial and/or nonallergic rhinitis
Key exclusion criteria (1 listed)
- Current smokers, digoxin, liver disease, anticoagulants (except for aspirin), planning a surgical procedure during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D versus placeboCross-over design | Dietary supplement | Placebo, Vitamin D |
Primary outcome
Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire.
Time frame: 6 weeks
1 secondary outcome
Associations between baseline serum vitamin D and subjects' demographics and treatment
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Columbo, M.D. principal investigator
Rohr and Columbo Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Rhinitis, run by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2014.