AsthmaNCT01284907
Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial
A study testing Vitamin D3 (Cholecalciferol) in people with Asthma, run by United Arab Emirates University at 2 sites in United Arab Emirates.
Trial summary
The purpose of this study is to determine whether vitamin D supplements can improve asthma control in children with moderate to severe asthma Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Vitamin D3 (Cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- Mar 2013to Dec 2013
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Physician diagnosed asthmatics and they should fulfill at least two of the following three criteria:
- A minimum of three clinic visits for acute asthma within 1 year
- Two or more asthma-related hospital admissions within 1 year, or
- Steroid dependency, as defined by either 6 months of oral or 1 year of inhaled corticosteroid use
- Age: 6-14 years old. The age group of 6 to 14 years old was chosen for two reasons:
- Diagnostic accuracy of asthma is better in this age group as non-specific wheezers less than 6 years of age could be excluded.
- Child should be able to use a peak flow meter and perform spirometry tests.
- A positive specific IgE or a positive skin prick test for at least one airborne allergen.
Who cannot join
- Children with mild intermittent and mild persistent asthma.
- Asthmatic children who are currently on immunotherapy or anti IgE.
- Asthmatic children with concomitant other medical problems.
- Children who are younger than 6 yrs or older than 14 yrs.
- Children with history of early life injury to airways like premature birth (< 36 weeks) or home use of oxygen.
- Children with vitamin D deficiency. Since these children may be randomized to the control group, they will be excluded for ethical reasons.
Trial locations and contacts
2 sites in 1 country.
United Arab Emirates2 sites
Tawam Hospital
Al Ain City, P. O. Box: 15258
Al Ain Hospital
Al Ain City, P.O.Box: 1006
About this study
The purpose of this study is to determine whether vitamin D supplements can improve asthma control in children with moderate to severe asthma
Read the detailed description
The proposed interventional study will clarify the role of vitamin D in preventing asthma exacerbations and in achieving better chronic asthma control in children with moderate to severe asthma.
- Conditions
- Asthma
- Being tested
- Vitamin D3 (Cholecalciferol), Placebo Drops
- Keywords
- Asthma, Asthma therapy, Randomized controlled trial, children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (Cholecalciferol)Dietary supplement
Also called Cholecalciferol
Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months
Placebo DropsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vit D | Active comparator | Not described Receives: Dietary Supplement: Vitamin D3 (Cholecalciferol) |
| Placebo drops | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change from baseline in Peak expiratory flow rate
Measured: up to six months
Secondary outcomes (1)
A change from baseline in lung function test
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startMar 2013
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: No Participants
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Arab Emirates University
- Sponsor type
- University, hospital or other
- Collaborators
- Roma Paediatrics
- Investigators
- Mariam Elremeli, MD, Principal investigator, Roma Paediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284907
- Sponsor's protocol ID
- AAMDHREC NO: 09/58
- Status last verified
- Dec 2014
- First submitted
- 24 Jan 2011
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01284907
- Acronym / sponsor ID
- AAMDHREC NO: 09/58
- Conditions
- Asthma
- Keywords
- Asthma, Asthma therapy, Randomized controlled trial, children
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United Arab Emirates UniversityUniversity, hospital or other
- Collaborators
- Roma Paediatrics
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 27 Jan 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 purpose of this study is to determine whether vitamin D supplements can improve asthma control in children with moderate to severe asthma
Detailed description
The proposed interventional study will clarify the role of vitamin D in preventing asthma exacerbations and in achieving better chronic asthma control in children with moderate to severe asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vit D | Active comparator | Dietary Supplement: Vitamin D3 (Cholecalciferol) |
| Placebo drops | Placebo comparator | Dietary Supplement: Placebo Drops |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Physician diagnosed asthmatics and they should fulfill at least two of the following three criteria:
- Age: 6-14 years old. The age group of 6 to 14 years old was chosen for two reasons:
- A positive specific IgE or a positive skin prick test for at least one airborne allergen.
Key exclusion criteria (6 listed)
- Children with mild intermittent and mild persistent asthma.
- Asthmatic children who are currently on immunotherapy or anti IgE.
- Asthmatic children with concomitant other medical problems.
- Children who are younger than 6 yrs or older than 14 yrs.
- Children with history of early life injury to airways like premature birth (< 36 weeks) or home use of oxygen.
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 D3 (Cholecalciferol)Also: CholecalciferolVit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months | Dietary supplement | Vit D |
| Placebo Drops | Dietary supplement | Placebo drops |
Primary outcome
A change from baseline in Peak expiratory flow rate
Time frame: up to six months
1 secondary outcome
A change from baseline in lung function test
Time frame: up to six months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 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.
Mariam Elremeli, MD principal investigator
Roma Paediatrics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 (Cholecalciferol) in people with Asthma, run by United Arab Emirates University at 2 sites in United Arab Emirates.
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 8 inclusion and 6 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: withdrawn, as of the sponsor's last update on 17 Dec 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 Arab Emirates. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
A change from baseline in Peak expiratory flow rate (time frame: up to six months). 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 17 Dec 2014.