Asthma in the ElderlyPhase 3NCT01730976
Asthma in the Elderly: The Role of Vitamin D
A Phase 3 study testing Vitamin D 2,000 I.U. in people with Asthma in the Elderly, run by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C. at 1 site in United States.
Trial summary
We will study whether taking vitamin D improves asthma control and spirometric values in elderly asthmatics. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Asthma in the Elderly
- What is being tested?
- Vitamin D 2,000 I.U.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Mar 2013
- 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
- Asthma, age of 65 years old or older
Who cannot join
- Current smokers, subjects who smoked more than 10 pack/year, subjects taking digoxin, subjects with liver disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Rohr and Columbo Asthma, Allergy and Immunology Specialists
Bryn Mawr, Pennsylvania, 19010
About this study
We will study whether taking vitamin D improves asthma control and spirometric values in elderly asthmatics.
- Conditions
- Asthma in the Elderly
- Being tested
- Vitamin D 2,000 I.U.
- Keywords
- asthma, elderly, vitamin D
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D 2,000 I.U.Dietary supplement
Also called Vitamin Shoppe
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D 2,000 I.U. daily | Experimental | Study subjects will take 2,000 I.U. vitamin D daily for three months Receives: Dietary Supplement: Vitamin D 2,000 I.U. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Asthma Control Test (ACT) score
Measured: Three months
Secondary outcomes (1)
Improvement in pulmonary function tests values (FEV1%, etc.)
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in the ElderlyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01730976
- Sponsor's protocol ID
- F/N-R13-3217B
- Other IDs
- SSRF2012-01
- Status last verified
- Sep 2014
- First submitted
- 15 Nov 2012
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Columbo M, Panettieri RA Jr, Rohr AS. Asthma in the elderly: a study of the role of vitamin D. Allergy Asthma Clin Immunol. 2014 Sep 5;10(1):48. doi: 10.1186/1710-1492-10-48. eCollection 2014.
PubMed 25221606
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma in the Elderly: The Role of Vitamin D
- ClinicalTrials.gov ID
- NCT01730976
- Acronym / sponsor ID
- F/N-R13-3217B
- Conditions
- Asthma in the Elderly
- Keywords
- asthma, elderly, vitamin D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.University, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Nov 2012 (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.
We will study whether taking vitamin D improves asthma control and spirometric values in elderly asthmatics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D 2,000 I.U. daily | Experimental | Dietary Supplement: Vitamin D 2,000 I.U.Study subjects will take 2,000 I.U. vitamin D daily for three months |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Asthma, age of 65 years old or older
Key exclusion criteria (1 listed)
- Current smokers, subjects who smoked more than 10 pack/year, subjects taking digoxin, subjects with liver disease
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 2,000 I.U.Also: Vitamin Shoppe | Dietary supplement | Vitamin D 2,000 I.U. daily |
Primary outcome
Improvement in Asthma Control Test (ACT) score
Time frame: Three months
1 secondary outcome
Improvement in pulmonary function tests values (FEV1%, etc.)
Time frame: Three months
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 10 Sep 2014.
- Derived from this study: PubMed 25221606Columbo M, Panettieri RA Jr, Rohr AS. Asthma in the elderly: a study of the role of vitamin D. Allergy Asthma Clin Immunol. 2014 Sep 5;10(1):48. doi: 10.1186/1710-1492-10-48. eCollection 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D 2,000 I.U. in people with Asthma in the Elderly, run by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C. at 1 site 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 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Improvement in Asthma Control Test (ACT) score (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01730976, which also lists 1 linked publication.
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 10 Sep 2014.