AsthmaPhase 2DIVA-pilotNCT01999907
Vitamin D to Reduce Colds and Asthma Attacks in Young Children
A Phase 2 study testing Vitamin D and daily vitamin D supplement in people with Asthma, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Viral infections are the main cause of asthma attacks in preschoolers, an age group with the highest rate of emergency visits due to asthma. While high doses of inhaled or oral corticosteroids provide benefits, these have been associated with adverse outcomes. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Asthma
- What is being tested?
- Vitamin D and daily vitamin D supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Aug 2014
- Phase
- Phase 2
- 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 1-5 years
- physician-diagnosed asthma as per GINA guidelines
- upper respiratory tract infections as the main asthma exacerbation trigger
- ≥4 respiratory infections in the past 12 months
- ≥1 exacerbation requiring rescue oral steroids in the past 6 months or ≥2 in the previous 12 months.
Who cannot join
- extreme prematurity (<28 weeks gestation)
- infants <12 months of age
- breastfed infants with no vitamin D supplementation
- recent (<1 year) immigrants from countries where rickets and malnutrition prevalent
- other chronic respiratory disease (broncho-pulmonary dysplasia; cystic fibrosis)
- endocrine disorder of calcium/ vitamin D metabolism
Show all 13Show fewer
- disorder/ disease with associated malabsorption (inflammatory bowel disease)
- kidney/ liver disease
- sickle cell anemia
- medications known to interfere with bone metabolism/ vitamin D levels
- vitamin D supplementation >1000 IU/ day in past 3 months
- unable to attend medical visit in 3-4 months
- plan to leave the province during the next 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D vs. Placebo in the Prevention of Viral-induced Exacerbations in Preschoolers With Asthma: a Pilot RCT
Viral infections are the main cause of asthma attacks in preschoolers, an age group with the highest rate of emergency visits due to asthma. While high doses of inhaled or oral corticosteroids provide benefits, these have been associated with adverse outcomes. Most asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children. Low vitamin D level has been linked to more frequent and more severe asthma attacks as well as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D supplements can reduce the number of asthma attacks triggered by viral infections in children. Unfortunately, most people forget to take vitamin D every day during the fall and winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth. This has been shown to safely and effectively increase vitamin D levels in children. The investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared with placebo in preschool-aged children with asthma. This six-month pilot randomized controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled participants; and (3) identify problems that may call for protocol changes.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called cholecalciferol
100,000IU cholecalciferol given in a 2ml dose by mouth at baseline.
daily vitamin D supplementDietary supplement
Also called cholecalciferol (Pediavit)
Each group receives a daily vitamin D supplement for 6 months, providing 400IU per day.
PlaceboOther
placebo given in a 2ml dose by mouth at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | bolus placebo given in a 2ml dose by mouth at baseline. This group receives daily vitamin D supplement by mouth for the 6 month study (400IU cholecalciferol per day). Receives: Dietary Supplement: daily vitamin D supplement; Other: Placebo |
| Vitamin D | Active comparator | Vitamin D (100,000IU) bolus in a 2ml dose by mouth given at baseline. This group receives a daily vitamin D supplement by mouth for 6 months (400IU cholecalciferol per day). Receives: Dietary Supplement: Vitamin D; Dietary Supplement: daily vitamin D supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum Vitamin D
mean change in serum vitamin D from baseline to 3 months
Measured: 3 months
Secondary outcomes (1)
adequate serum vitamin D
difference in the proportion of children with serum vitamin D ≥75nmol/L at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Francine Ducharme, St. Justine's Hospital
- Investigators
- Francine M Ducharme, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999907
- Sponsor's protocol ID
- VD0001
- Other IDs
- 12140
- Acronym
- DIVA-pilot
- Status last verified
- Jan 2015
- First submitted
- 25 Nov 2013
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
PubMed 33305842Jensen ME, Mailhot G, Alos N, Rousseau E, White JH, Khamessan A, Ducharme FM. Vitamin D intervention in preschoolers with viral-induced asthma (DIVA): a pilot randomised controlled trial. Trials. 2016 Jul 26;17(1):353. doi: 10.1186/s13063-016-1483-1.
PubMed 27456232
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D vs. Placebo in the Prevention of Viral-induced Exacerbations in Preschoolers With Asthma: a Pilot RCT
- ClinicalTrials.gov ID
- NCT01999907
- Acronym / sponsor ID
- DIVA-pilot / VD0001
- Conditions
- Asthma
- Keywords
- asthma, virus diseases, pediatric, RCT, steroid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Dec 2013 (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.
Viral infections are the main cause of asthma attacks in preschoolers, an age group with the highest rate of emergency visits due to asthma. While high doses of inhaled or oral corticosteroids provide benefits, these have been associated with adverse outcomes. Most asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children. Low vitamin D level has been linked to more frequent and more severe asthma attacks as well as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D supplements can reduce the number of asthma attacks triggered by viral infections in children. Unfortunately, most people forget to take vitamin D every day during the fall and winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth. This has been shown to safely and effectively increase vitamin D levels in children. The investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared with placebo in preschool-aged children with asthma. This six-month pilot randomized controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled participants; and (3) identify problems that may call for protocol changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: daily vitamin D supplement, Other: Placebobolus placebo given in a 2ml dose by mouth at baseline. This group receives daily vitamin D supplement by mouth for the 6 month study (400IU cholecalciferol per day). |
| Vitamin D | Active comparator | Dietary Supplement: Vitamin D, Dietary Supplement: daily vitamin D supplementVitamin D (100,000IU) bolus in a 2ml dose by mouth given at baseline. This group receives a daily vitamin D supplement by mouth for 6 months (400IU cholecalciferol per day). |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children aged 1-5 years
- physician-diagnosed asthma as per GINA guidelines
- upper respiratory tract infections as the main asthma exacerbation trigger
- ≥4 respiratory infections in the past 12 months
- ≥1 exacerbation requiring rescue oral steroids in the past 6 months or ≥2 in the previous 12 months.
Key exclusion criteria (13 listed)
- extreme prematurity (<28 weeks gestation)
- infants <12 months of age
- breastfed infants with no vitamin D supplementation
- recent (<1 year) immigrants from countries where rickets and malnutrition prevalent
- other chronic respiratory disease (broncho-pulmonary dysplasia; cystic fibrosis)
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 DAlso: cholecalciferol100,000IU cholecalciferol given in a 2ml dose by mouth at baseline. | Dietary supplement | Vitamin D |
| daily vitamin D supplementAlso: cholecalciferol (Pediavit)Each group receives a daily vitamin D supplement for 6 months, providing 400IU per day. | Dietary supplement | Placebo, Vitamin D |
| Placeboplacebo given in a 2ml dose by mouth at baseline. | Other | Placebo |
Primary outcome
serum Vitamin D
Time frame: 3 months
mean change in serum vitamin D from baseline to 3 months
1 secondary outcome
adequate serum vitamin D
Time frame: 3 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 12 Jan 2015.
- Derived from this study: PubMed 33305842Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
- Derived from this study: PubMed 27456232Jensen ME, Mailhot G, Alos N, Rousseau E, White JH, Khamessan A, Ducharme FM. Vitamin D intervention in preschoolers with viral-induced asthma (DIVA): a pilot randomised controlled trial. Trials. 2016 Jul 26;17(1):353. doi: 10.1186/s13063-016-1483-1.
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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.
Francine M Ducharme principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D and daily vitamin D supplement in people with Asthma, run by St. Justine's Hospital at 1 site in Canada.
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 5 inclusion and 13 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 12 Jan 2015. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
serum Vitamin D (time frame: 3 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 NCT01999907, which also lists 2 linked publications.
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 12 Jan 2015.