Respiratory Tract InfectionsPhase 3DO ITNCT01419262
DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
A Phase 3 study testing Vitamin D - Cholecalciferol 400 IU and Vitamin D3 - Cholecalciferol 2000 IU in people with Respiratory Tract Infections and Asthma, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods. Vitamin D levels are alarmingly low in many North American children. Several health issues have been linked with low vitamin D. These include colds caused by viruses and asthma attacks. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Asthma, Avitaminosis
- What is being tested?
- Vitamin D - Cholecalciferol 400 IU and Vitamin D3 - Cholecalciferol 2000 IU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 703 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2011to Oct 2015
- 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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children by parental report
- Have reached their 1st birthday but not past their 6th birthday
- Present to a TARGet Kids! practice for routine primary healthcare prior to viral season (September through November)
- Parents provide informed consent to participate.
Who cannot join
- Children with gestational age < 32 weeks
- Children with chronic illness (except for asthma) on parental report which is known to interfere with vitamin D metabolism and increase the risk of respiratory infection
- Children with a sibling participating in the study to reduce clustering effects.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods. Vitamin D levels are alarmingly low in many North American children. Several health issues have been linked with low vitamin D. These include colds caused by viruses and asthma attacks. However, no study has determined whether vitamin D supplementation can reduce the risk of these conditions in young children where they are most common and most severe.
The goals of this study are to determine whether wintertime high dose vitamin D supplementation of preschoolers can prevent colds and asthma attacks. The investigators also aim to work out how much money would be saved by the health care system and society if preschoolers were routinely supplemented with Vitamin D during the winter. The investigators believe that preschoolers receiving 'high dose' vitamin D supplementation during the wintertime will be less likely to have colds, asthma attacks, and low vitamin D levels and will be less likely to use the medical system and keep their parents away from work.
- Conditions
- Respiratory Tract Infections, Asthma, Avitaminosis
- Being tested
- Vitamin D - Cholecalciferol 400 IU, Vitamin D3 - Cholecalciferol 2000 IU
- Keywords
- Vitamin D, Randomized Controlled Trial, Child, Preschool, Dietary Supplements, Respiratory Tract Infections, Asthma
- Medical subject headings
- Respiratory Tract Infections, Asthma, Avitaminosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D - Cholecalciferol 400 IUDrug
Also called Baby Ddrops, Health Canada NPN #80001869
One drop per day (liquid), 400 IU, 4 to 9 months depending on date of enrollment and date of follow-up
Vitamin D3 - Cholecalciferol 2000 IUDrug
Also called Ddrops 2000 IU
One drop per day (liquid), 2000 IU, 4 to 9 months depending on date of enrollment and date of follow-up
| Study group | Role | What they receive |
|---|---|---|
| 2000 IU per day vitamin D | Experimental | Not described Receives: Drug: Vitamin D3 - Cholecalciferol 2000 IU |
| 400 IU per day vitamin D | Active comparator | Not described Receives: Drug: Vitamin D - Cholecalciferol 400 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Laboratory confirmed upper respiratory tract infections
Parents of enrolled children will be asked to obtain a nasal swab from their child and complete a symptom checklist with each URTI. Reverse transcriptase polymerase chain reaction will be performed on each sample. Samples will be tested for 18 common respiratory viruses using the ID-TagTM RVP assay using the Luminex xMAPTM system.
Measured: Up to 8 months
Secondary outcomes (4)
Number of parent reported upper respiratory tract infections
Parental reported URTI symptoms will be defined as two or more of fever, cough, runny nose, sore throat, headache, vomiting, feels unwell, muscle aches, ear ache or infection, poor appetite, not sleeping well, cranky/fussy, low energy or crying more than usual from a validated parent completed symptom checklist.
Measured: Up to 8 months
Number of Asthma exacerbations
Asthma exacerbation will be defined as a wheezing episode in children with asthma as obtained from parent completed symptom checklist based on the International Study of Asthma and Allergies in Childhood (ISAAC).
Measured: Up to 8 months
Serum vitamin D level
Blood for serum levels will be drawn by trained pediatric phlebotomists from for determination of 25-hydroxyvitamin D. Total 25-hydroxyvitamin D will be measured from serum samples using a competitive two-step chemiluminescence assay.
Measured: 5-8months
Direct and indirect economic costs associated with upper respiratory tract infections
Cost-consequence and cost-effectiveness analyses will be conducted using data from this clinical trial. A societal perspective will be employed as both direct health service utilization costs as well as indirect costs to families from URTI will be calculated for the 400 IU per day versus 2000 IU per day groups.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2015
- Study completionOct 2015
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 Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 703 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada, Unity Health Toronto
- Responsible party
- Principal investigator, Jonathon L Maguire, The Hospital for Sick Children
- Investigators
- Jonathon L Maguire, MD, MSc, Principal investigator, St. Michael's Hospital, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419262
- Sponsor's protocol ID
- 1000025147
- Acronym
- DO IT
- Status last verified
- Jun 2019
- First submitted
- 16 Aug 2011
- Last updated
- 14 Jun 2019
- 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 33305842Aglipay M, Birken CS, Parkin PC, Loeb MB, Thorpe K, Chen Y, Laupacis A, Mamdani M, Macarthur C, Hoch JS, Mazzulli T, Maguire JL; TARGet Kids! Collaboration. Effect of High-Dose vs Standard-Dose Wintertime Vitamin D Supplementation on Viral Upper Respiratory Tract Infections in Young Healthy Children. JAMA. 2017 Jul 18;318(3):245-254. doi: 10.1001/jama.2017.8708.
PubMed 28719693
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
- ClinicalTrials.gov ID
- NCT01419262
- Acronym / sponsor ID
- DO IT / 1000025147
- Conditions
- Respiratory Tract Infections, Asthma, Avitaminosis
- Keywords
- Vitamin D, Randomized Controlled Trial, Child, Preschool, Dietary Supplements, Respiratory Tract Infections, Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 703 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada, Unity Health Toronto
- Study start
- Sep 2011
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Aug 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.
Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods. Vitamin D levels are alarmingly low in many North American children. Several health issues have been linked with low vitamin D. These include colds caused by viruses and asthma attacks. However, no study has determined whether vitamin D supplementation can reduce the risk of these conditions in young children where they are most common and most severe.
The goals of this study are to determine whether wintertime high dose vitamin D supplementation of preschoolers can prevent colds and asthma attacks. The investigators also aim to work out how much money would be saved by the health care system and society if preschoolers were routinely supplemented with Vitamin D during the winter. The investigators believe that preschoolers receiving 'high dose' vitamin D supplementation during the wintertime will be less likely to have colds, asthma attacks, and low vitamin D levels and will be less likely to use the medical system and keep their parents away from work.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2000 IU per day vitamin D | Experimental | Drug: Vitamin D3 - Cholecalciferol 2000 IU |
| 400 IU per day vitamin D | Active comparator | Drug: Vitamin D - Cholecalciferol 400 IU |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children by parental report
- Have reached their 1st birthday but not past their 6th birthday
- Present to a TARGet Kids! practice for routine primary healthcare prior to viral season (September through November)
- Parents provide informed consent to participate.
Key exclusion criteria (3 listed)
- Children with gestational age < 32 weeks
- Children with chronic illness (except for asthma) on parental report which is known to interfere with vitamin D metabolism and increase the risk of respiratory infection
- Children with a sibling participating in the study to reduce clustering effects.
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 - Cholecalciferol 400 IUAlso: Baby Ddrops, Health Canada NPN #80001869One drop per day (liquid), 400 IU, 4 to 9 months depending on date of enrollment and date of follow-up | Drug | 400 IU per day vitamin D |
| Vitamin D3 - Cholecalciferol 2000 IUAlso: Ddrops 2000 IUOne drop per day (liquid), 2000 IU, 4 to 9 months depending on date of enrollment and date of follow-up | Drug | 2000 IU per day vitamin D |
Primary outcome
Number of Laboratory confirmed upper respiratory tract infections
Time frame: Up to 8 months
Parents of enrolled children will be asked to obtain a nasal swab from their child and complete a symptom checklist with each URTI. Reverse transcriptase polymerase chain reaction will be performed on each sample. Samples will be tested for 18 common respiratory viruses using the ID-TagTM RVP assay using the Luminex xMAPTM system.
4 secondary outcomes
Number of parent reported upper respiratory tract infections
Time frame: Up to 8 months
Number of Asthma exacerbations
Time frame: Up to 8 months
Serum vitamin D level
Time frame: 5-8months
Direct and indirect economic costs associated with upper respiratory tract infections
Time frame: 16 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 14 Jun 2019.
- 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 28719693Aglipay M, Birken CS, Parkin PC, Loeb MB, Thorpe K, Chen Y, Laupacis A, Mamdani M, Macarthur C, Hoch JS, Mazzulli T, Maguire JL; TARGet Kids! Collaboration. Effect of High-Dose vs Standard-Dose Wintertime Vitamin D Supplementation on Viral Upper Respiratory Tract Infections in Young Healthy Children. JAMA. 2017 Jul 18;318(3):245-254. doi: 10.1001/jama.2017.8708.
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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.
Jonathon L Maguire, MD, MSc principal investigator
St. Michael's Hospital, Toronto, Ontario, Canada
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 testing Vitamin D - Cholecalciferol 400 IU and Vitamin D3 - Cholecalciferol 2000 IU in people with Respiratory Tract Infections and Asthma, run by The Hospital for Sick Children at 2 sites 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 4 inclusion and 3 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 14 Jun 2019. 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 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. 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?
Number of Laboratory confirmed upper respiratory tract infections (time frame: Up to 8 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 NCT01419262, 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 14 Jun 2019.