AsthmaPhase 4NCT01447173
Vitamin and Asthma Study
A Phase 4 study testing Vitamin D in people with Asthma, run by Augusta University at 1 site in United States.
Trial summary
The study looks at how vitamin D supplement will improve the severity of asthma and lung function as well as biomarkers in asthmatic children. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 2011
- Phase
- Phase 4
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- History of asthma (under control)otherwise in good general health
Who cannot join
- Poorly controlled asthma
- Taking daily multivitamin or vitamin D supplementation
- Taking oral steroid medication
- History of bronchopulmonary dysplasia or chronic lung disease, extreme prematurity, congenital heart disease, significant renal dysfunction or primary kidney disease, endocrinologic abnormalities of calcium metabolism or parathyroid disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatrics Allergy Clinic at Georgia Health Sciences University
Augusta, Georgia, 30912
About this study
The study looks at how vitamin D supplement will improve the severity of asthma and lung function as well as biomarkers in asthmatic children.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Vitamin D 2000 IU daily pill Vitamin D 400 IU daily pill
| Study group | Role | What they receive |
|---|---|---|
| 2000 IU vitamin D Daily | Experimental | Not described Receives: Drug: Vitamin D |
| 400 IU Vitamin D pill | Placebo comparator | Not described Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulmonary Function Test (PFT) after vitamin D supplementation
Measured: 4 weeks
Change in Asthma Control Test (ACT) scores after vitamin D supplementation
Measured: 4-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startDec 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbin Dong, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447173
- Sponsor's protocol ID
- VDAS
- Status last verified
- Oct 2012
- First submitted
- 3 Oct 2011
- Last updated
- 23 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin and Asthma Study
- ClinicalTrials.gov ID
- NCT01447173
- Acronym / sponsor ID
- VDAS
- Conditions
- Asthma
- Keywords
- Asthma, Pulmonary Function Test, Vitamin D
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 6 Oct 2011 (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.
The study looks at how vitamin D supplement will improve the severity of asthma and lung function as well as biomarkers in asthmatic children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2000 IU vitamin D Daily | Experimental | Drug: Vitamin D |
| 400 IU Vitamin D pill | Placebo comparator | Drug: Vitamin D |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- History of asthma (under control)otherwise in good general health
Key exclusion criteria (4 listed)
- Poorly controlled asthma
- Taking daily multivitamin or vitamin D supplementation
- Taking oral steroid medication
- History of bronchopulmonary dysplasia or chronic lung disease, extreme prematurity, congenital heart disease, significant renal dysfunction or primary kidney disease, endocrinologic abnormalities of calcium metabolism or parathyroid disorders
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 DVitamin D 2000 IU daily pill Vitamin D 400 IU daily pill | Drug | 2000 IU vitamin D Daily, 400 IU Vitamin D pill |
Primary outcome
Change in Pulmonary Function Test (PFT) after vitamin D supplementation
Time frame: 4 weeks
Change in Asthma Control Test (ACT) scores after vitamin D supplementation
Time frame: 4-week
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 23 Oct 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Asthma, run by Augusta University 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 4 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 23 Oct 2012. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in Pulmonary Function Test (PFT) after vitamin D supplementation (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 23 Oct 2012.