Recurrent Respiratory Tract InfectionsPhase 4NCT02617771
Impact of Vitamin D Supplementation on Recurrent Respiratory Infections in Paediatric Primary Care.
A Phase 4 study testing Vitamin D3 in people with Recurrent Respiratory Tract Infections, run by Policlinico Hospital.
Trial summary
Up to date, some clinical trial have evaluated the efficacy and safety of Vitamin D supplementation in children with RRI, with no conclusive information. Therefore, the investigators designed a prospective, single-blind, clinical trial to evaluate whether oral supplementation with vitamin D from October to April… Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Recurrent Respiratory Tract Infections
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Nov 2015
- 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 6 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients diagnosed the seasons before with: ≥ 6 respiratory infections per annum
- ≥ 1 respiratory infections per month involving the upper airways from September to April
- ≥ 3 respiratory infections per annum involving the lower airways
Who cannot join
- patients with findings suggestive of an immunodeficiency on history and physical examination
About this study
Official title: Impact of Vitamin D Supplementation on Recurrent Respiratory Infections in Paediatric
Up to date, some clinical trial have evaluated the efficacy and safety of Vitamin D supplementation in children with RRI, with no conclusive information.
Therefore, the investigators designed a prospective, single-blind, clinical trial to evaluate whether oral supplementation with vitamin D from October to April reduces the global health burden of recurrent respiratory tract infections in a primary care setting.
Read more
The primary outcome was evaluated if Vitamin D supplementation during autumn and winter can reduce the number of respiratory tract infections in children diagnosed with recurrent respiratory tract infections the seasons before.
Secondary objectives was the assessment of Vitamin D supplementation benefits on global socioeconomic burden of recurrent respiratory tract infections in a primary care setting, according to number of visits to the primary care paediatrician and use of antibiotics due to respiratory tract infections.
Read the detailed description
The University study personnel randomly allocated patients to receive, from October to March, a Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year) or not.
Randomization was performed using a free web-based service that offers random assignment; patients were randomized considering gender and age class (up to 12 months; beyond 1 years). The primary care practitioner was blinded regarding the study group allocation.
Inclusion criteria were: a) patients diagnosed the seasons before with: ≥ 6 respiratory infections per annum OR ≥ 1 respiratory infections per month involving the upper airways from September to April OR ≥ 3 respiratory infections per annum involving the lower airways. b) patients with no findings suggestive of an immunodeficiency on history and physical examination.
From the recruitment, parents recorded number and type of diagnosed respiratory tract infections, number of ambulatory visits, use of antibiotics and duration of symptoms in a structured diary.
Upper Respiratory Tract Infections (URTIs) comprehends diagnosis of acute otitis media, acute rhinosinusitis and acute pharyngotonsillitis. Lower Respiratory Tract Infections (LRTIs) comprehend diagnosis of bronchiolitis and pneumonia.
All parents had a close telephone contact to help them in the diary compilation. Adverse events related to the protocol were monitored. Missing data were recovered through the information system of the primary care practitioner.
Quantitative data were expressed as mean and standard deviation. To compare the mean between the two groups, Student's t-test for unpaired was used. The frequency of each visits to the pediatricians and use of antibiotics in the two group was calculated and expressed as a percentage. The χ² test was used to compare the percentages between the two groups. For all tests, P-values <0.05 were considered significant.
Since Italian National Health System covers all costs for pediatrician visits and antibiotics, cost assessment was made analysing the costs regarding the frequency of each parameters in treated and nontreated group. We considered as direct cost National Health System: Medical examination (20,66 euros for each examination, as provided by the Italian Ministry of Health) and use of Antibiotics (the cost was as in the list of the National Drug Authority).
- Conditions
- Recurrent Respiratory Tract Infections
- Being tested
- Vitamin D3
- 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 D3Drug
from October to March, a Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year
| Study group | Role | What they receive |
|---|---|---|
| Vit D | Active comparator | Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year) from October to March Receives: Drug: Vitamin D3 |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of recurrent respiratory tract infections for each months of study
reduction of the number of respiratory tract infections in children diagnosed with recurrent respiratory tract infections the seasons before
Measured: From October 1, 2014, and March 31, 2015, up to 6 months
Secondary outcomes (1)
Cost assessment in euros according to antibiotics, paediatric visits and vitamin D supplementation
Secondary objectives was the assessment of Vitamin D supplementation benefits on global socioeconomic burden of recurrent respiratory tract infections in a primary care setting, according to number of visits to the primary care paediatrician and use of antibiotics due to respiratory tract infections.
Measured: From October 1, 2014, and March 31, 2015, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionNov 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 Recurrent Respiratory Tract InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Maria Elisabetta Baldassarre, Policlinico Hospital
- Investigators
- Maria Elisabetta Baldassarre, MD, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617771
- Sponsor's protocol ID
- VITDBA1
- Status last verified
- Mar 2019
- First submitted
- 23 Nov 2015
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
de Sa Del Fiol F, Barberato-Filho S, Lopes LC, de Cassia Bergamaschi C. Vitamin D and respiratory infections. J Infect Dev Ctries. 2015 Apr 15;9(4):355-61. doi: 10.3855/jidc.5711.
PubMed 25881523Zittermann A, Gummert JF. Nonclassical vitamin D action. Nutrients. 2010 Apr;2(4):408-25. doi: 10.3390/nu2040408. Epub 2010 Mar 25.
PubMed 22254030
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D Supplementation on Recurrent Respiratory Infections in Paediatric
- ClinicalTrials.gov ID
- NCT02617771
- Acronym / sponsor ID
- VITDBA1
- Conditions
- Recurrent Respiratory Tract Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Dec 2015 (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.
Up to date, some clinical trial have evaluated the efficacy and safety of Vitamin D supplementation in children with RRI, with no conclusive information.
Therefore, the investigators designed a prospective, single-blind, clinical trial to evaluate whether oral supplementation with vitamin D from October to April reduces the global health burden of recurrent respiratory tract infections in a primary care setting.
The primary outcome was evaluated if Vitamin D supplementation during autumn and winter can reduce the number of respiratory tract infections in children diagnosed with recurrent respiratory tract infections the seasons before.
Secondary objectives was the assessment of Vitamin D supplementation benefits on global socioeconomic burden of recurrent respiratory tract infections in a primary care setting, according to number of visits to the primary care paediatrician and use of antibiotics due to respiratory tract infections.
Detailed description
The University study personnel randomly allocated patients to receive, from October to March, a Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year) or not.
Randomization was performed using a free web-based service that offers random assignment; patients were randomized considering gender and age class (up to 12 months; beyond 1 years). The primary care practitioner was blinded regarding the study group allocation.
Inclusion criteria were: a) patients diagnosed the seasons before with: ≥ 6 respiratory infections per annum OR ≥ 1 respiratory infections per month involving the upper airways from September to April OR ≥ 3 respiratory infections per annum involving the lower airways. b) patients with no findings suggestive of an immunodeficiency on history and physical examination.
From the recruitment, parents recorded number and type of diagnosed respiratory tract infections, number of ambulatory visits, use of antibiotics and duration of symptoms in a structured diary.
Upper Respiratory Tract Infections (URTIs) comprehends diagnosis of acute otitis media, acute rhinosinusitis and acute pharyngotonsillitis. Lower Respiratory Tract Infections (LRTIs) comprehend diagnosis of bronchiolitis and pneumonia.
All parents had a close telephone contact to help them in the diary compilation. Adverse events related to the protocol were monitored. Missing data were recovered through the information system of the primary care practitioner.
Quantitative data were expressed as mean and standard deviation. To compare the mean between the two groups, Student's t-test for unpaired was used. The frequency of each visits to the pediatricians and use of antibiotics in the two group was calculated and expressed as a percentage. The χ² test was used to compare the percentages between the two groups. For all tests, P-values <0.05 were considered significant.
Since Italian National Health System covers all costs for pediatrician visits and antibiotics, cost assessment was made analysing the costs regarding the frequency of each parameters in treated and nontreated group. We considered as direct cost National Health System: Medical examination (20,66 euros for each examination, as provided by the Italian Ministry of Health) and use of Antibiotics (the cost was as in the list of the National Drug Authority).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vit D | Active comparator | Drug: Vitamin D3Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year) from October to March |
| Control | No intervention | – |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patients diagnosed the seasons before with: ≥ 6 respiratory infections per annum
- ≥ 1 respiratory infections per month involving the upper airways from September to April
- ≥ 3 respiratory infections per annum involving the lower airways
Key exclusion criteria (1 listed)
- patients with findings suggestive of an immunodeficiency on history and physical examination
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 D3from October to March, a Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year | Drug | Vit D |
Primary outcome
Number of recurrent respiratory tract infections for each months of study
Time frame: From October 1, 2014, and March 31, 2015, up to 6 months
reduction of the number of respiratory tract infections in children diagnosed with recurrent respiratory tract infections the seasons before
1 secondary outcome
Cost assessment in euros according to antibiotics, paediatric visits and vitamin D supplementation
Time frame: From October 1, 2014, and March 31, 2015, up to 6 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 20 Mar 2019.
- Background: PubMed 25881523de Sa Del Fiol F, Barberato-Filho S, Lopes LC, de Cassia Bergamaschi C. Vitamin D and respiratory infections. J Infect Dev Ctries. 2015 Apr 15;9(4):355-61. doi: 10.3855/jidc.5711.
- Results publication: PubMed 22254030Zittermann A, Gummert JF. Nonclassical vitamin D action. Nutrients. 2010 Apr;2(4):408-25. doi: 10.3390/nu2040408. Epub 2010 Mar 25.
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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.
Maria Elisabetta Baldassarre, MD principal investigator
University of Bari
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D3 in people with Recurrent Respiratory Tract Infections, run by Policlinico Hospital.
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 3 inclusion and 1 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 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Number of recurrent respiratory tract infections for each months of study (time frame: From October 1, 2014, and March 31, 2015, up to 6 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 NCT02617771, 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 20 Mar 2019.