Respiratory InfectionNCT01705314
A Randomized Trial of Vitamin D to Reduce Respiratory Infection
A study testing vitamin D supplements in people with Respiratory Infection, run by McMaster University at 1 site in Vietnam.
Trial summary
The goal of this study is to assess the effectiveness of vitamin D in reducing laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha Commune, Thanh Liem District, Ha Nam Province, Vietnam will be… Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Infection
- What is being tested?
- vitamin D supplements
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,300 participants
- Where
- 1 siteVietnam
- Study dates
- Dec 2014to May 2016
- 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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between the ages of 3 and 17
- Residing in Thanh Liem District, Ha Nam Province, Vietnam
Who cannot join
- Born prematurely at less than 32 weeks gestation
- Any chronic illness (except asthma)
- Currently using medication known to interfere with vitamin D metabolism
- Children with a sibling participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vitamin D3 Supplementation to Reduce Respiratory Infections in Children and Adolescents in Vietnam: A Blinded, Placebo-controlled Randomized Controlled Trial
The goal of this study is to assess the effectiveness of vitamin D in reducing laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly vitamin D supplements or placebo. Participants who develop acute respiratory infection over a 12-month period, will be tested for influenza, the co-primary outcome, and other respiratory viruses, the other co-primary outcome, by RT-PCR.
- Conditions
- Respiratory Infection
- Being tested
- vitamin D supplements, placebo
- Keywords
- human influenza children
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D supplementsDietary supplement
Participants will receive 7mls of D-drops (14,000U/week of vitamin D)
placeboDietary supplement
7mls of placebo drops per week for 8 months.
| Study group | Role | What they receive |
|---|---|---|
| vitamin D supplements | Experimental | children and adolescents that are randomized to the intervention will receive 7 mls of D-drops (14,000U/week of vitamin D) for eight months Receives: Dietary Supplement: vitamin D supplements |
| vitamin D placebo | Placebo comparator | children and adolescents that are randomized to placebo will receive 7 mls of placebo drops for eight months Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory-confirmed non-influenza infection
Measured: 12 months
Laboratory-confirmed influenza infection
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startDec 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Loeb, MD, Principal investigator, McMaster University, Hamilton, ON, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705314
- Sponsor's protocol ID
- VitD2012
- Status last verified
- Oct 2016
- First submitted
- 9 Oct 2012
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D3 Supplementation to Reduce Respiratory Infections in Children and Adolescents in Vietnam: A Blinded, Placebo-controlled Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01705314
- Acronym / sponsor ID
- VitD2012
- Conditions
- Respiratory Infection
- Keywords
- human influenza children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 Oct 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.
The goal of this study is to assess the effectiveness of vitamin D in reducing laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly vitamin D supplements or placebo. Participants who develop acute respiratory infection over a 12-month period, will be tested for influenza, the co-primary outcome, and other respiratory viruses, the other co-primary outcome, by RT-PCR.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D supplements | Experimental | Dietary Supplement: vitamin D supplementschildren and adolescents that are randomized to the intervention will receive 7 mls of D-drops (14,000U/week of vitamin D) for eight months |
| vitamin D placebo | Placebo comparator | Dietary Supplement: placebochildren and adolescents that are randomized to placebo will receive 7 mls of placebo drops for eight months |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Between the ages of 3 and 17
- Residing in Thanh Liem District, Ha Nam Province, Vietnam
Key exclusion criteria (4 listed)
- Born prematurely at less than 32 weeks gestation
- Any chronic illness (except asthma)
- Currently using medication known to interfere with vitamin D metabolism
- Children with a sibling participating in the study
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 supplementsParticipants will receive 7mls of D-drops (14,000U/week of vitamin D) | Dietary supplement | vitamin D supplements |
| placebo7mls of placebo drops per week for 8 months. | Dietary supplement | vitamin D placebo |
Primary outcome
Laboratory-confirmed non-influenza infection
Time frame: 12 months
Laboratory-confirmed influenza infection
Time frame: 12 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 26 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Mark Loeb, MD principal investigator
McMaster University, Hamilton, ON, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D supplements in people with Respiratory Infection, run by McMaster University at 1 site in Vietnam.
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 2 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 26 Oct 2016. 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 Vietnam. 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 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?
Laboratory-confirmed non-influenza infection (time frame: 12 months). 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 26 Oct 2016.