Acute BronchitisPhase 3VitDBR2012NCT01875757
Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life
A Phase 3 study testing Vitamin D3 in people with Acute Bronchitis and Upper Respiratory Tract Infection, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
A phase III multicenter randomized double blind clinical trial will be conducted. After obtaining written consent the infant will be randomized, during the first two weeks of life, to a study group to receive either 400 IU or 1,000 IU / day of vitamin D to the year of age. Read more about this study
- Who is it for?
- Ages Up to 19 days
- Conditions the study is for
- Acute Bronchitis, Upper Respiratory Tract Infection, Acute Bronchiolitis
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2013to Dec 2016
- 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 Up to 19 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy term born infants of appropriate size for gestational age
- Parents provide informed consent to participate
Who cannot join
- Infants with small size for gestational age
- Infants with gestational age < 37 weeks
- Infants with congenital anomalies
- Infants with chronic gastrointestinal tract, liver, kidney, heart, or neurological diseases
- Infants with disorders of vitamin D or calcium metabolism or others inborn errors of metabolism
Trial locations and contacts
1 site in 1 country.
About this study
A phase III multicenter randomized double blind clinical trial will be conducted. After obtaining written consent the infant will be randomized, during the first two weeks of life, to a study group to receive either 400 IU or 1,000 IU / day of vitamin D to the year of age.
Baseline and all follow up visits (2, 6, and 12 months of life) will include anthropometric measurements and a questionnaire about health issues. A blood sample will be obtained at baseline for analysis of 25OH vitamin D, and at 6 and 12 months for analysis of 25 OH vitamin D, and calcium.
Read more
Healthy term born infants of appropriate size for gestational age will be included. We will need to include 359 children in each group.
The primary objective of the study is to decrease the proportion of infants with acute bronchitis during the first year of life by supplementation of 1,000 IU/day vitamin D. Secondary otcomes are: To check that the administration of 1,000 IU/day vitamin D decreases the proportion of infants with upper respiratory tract infections, the proportion of children under one year of age hospitalized for acute bronchiolitis, and the demand on the healthcare system due to respiratory infections and absences from work for parents and achieves a higher proportion of children with adequate blood levels 25 OH vitamin D.
- Being tested
- Vitamin D3, Placebo
- Keywords
- Vitamin D, Acute bronchitis, Upper respiratory tract infection, Recurrent bronchitis, Acute bronchiolitis, Infants
- Medical subject headings
- Bronchitis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 1000 IU/day | Experimental | Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 1.000 IU/day during the first year of life, taking into account the vitamin D received with artificial milk Receives: Drug: Vitamin D3; Drug: Placebo |
| Vitamin D3 400 IU/day | Active comparator | Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 400 IU/day during the first year of life, taking into account the vitamin D received with artificial milk Receives: Drug: Vitamin D3; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children with acute bronchitis
Check that the administration of a vitamin D dose of 1,000 U / day decreases the percentage of children with acute bronchitis during the first year of life
Measured: 1 year
Secondary outcomes (1)
Number of episodes of upper respiratory infections reported by parents in the first year of life
Check that the supplementation of vitamin D of 1,000 units / day decreases the number of upper respiratory infections
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute BronchitisStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Moreno, MD, PhD, Study chair, Hospital Universitari Vall d'hebron Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875757
- Sponsor's protocol ID
- 2012-001152-19
- Other IDs
- 2012-001152-19
- Acronym
- VitDBR2012
- Status last verified
- Mar 2017
- First submitted
- 10 Jun 2013
- Last updated
- 22 Mar 2017
- Results posted
- No
Publications
Camargo CA Jr, Ingham T, Wickens K, Thadhani R, Silvers KM, Epton MJ, Town GI, Pattemore PK, Espinola JA, Crane J; New Zealand Asthma and Allergy Cohort Study Group. Cord-blood 25-hydroxyvitamin D levels and risk of respiratory infection, wheezing, and asthma. Pediatrics. 2011 Jan;127(1):e180-7. doi: 10.1542/peds.2010-0442. Epub 2010 Dec 27.
PubMed 21187313Belderbos ME, Houben ML, Wilbrink B, Lentjes E, Bloemen EM, Kimpen JL, Rovers M, Bont L. Cord blood vitamin D deficiency is associated with respiratory syncytial virus bronchiolitis. Pediatrics. 2011 Jun;127(6):e1513-20. doi: 10.1542/peds.2010-3054. Epub 2011 May 9.
PubMed 21555499Karatekin G, Kaya A, Salihoglu O, Balci H, Nuhoglu A. Association of subclinical vitamin D deficiency in newborns with acute lower respiratory infection and their mothers. Eur J Clin Nutr. 2009 Apr;63(4):473-7. doi: 10.1038/sj.ejcn.1602960. Epub 2007 Nov 21.
PubMed 18030309Urashima M, Segawa T, Okazaki M, Kurihara M, Wada Y, Ida H. Randomized trial of vitamin D supplementation to prevent seasonal influenza A in schoolchildren. Am J Clin Nutr. 2010 May;91(5):1255-60. doi: 10.3945/ajcn.2009.29094. Epub 2010 Mar 10.
PubMed 20219962Devereux G, Litonjua AA, Turner SW, Craig LC, McNeill G, Martindale S, Helms PJ, Seaton A, Weiss ST. Maternal vitamin D intake during pregnancy and early childhood wheezing. Am J Clin Nutr. 2007 Mar;85(3):853-9. doi: 10.1093/ajcn/85.3.853.
PubMed 17344509Camargo CA Jr, Rifas-Shiman SL, Litonjua AA, Rich-Edwards JW, Weiss ST, Gold DR, Kleinman K, Gillman MW. Maternal intake of vitamin D during pregnancy and risk of recurrent wheeze in children at 3 y of age. Am J Clin Nutr. 2007 Mar;85(3):788-95. doi: 10.1093/ajcn/85.3.788.
PubMed 17344501
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life
- ClinicalTrials.gov ID
- NCT01875757
- Acronym / sponsor ID
- VitDBR2012 / 2012-001152-19
- Keywords
- Vitamin D, Acute bronchitis, Upper respiratory tract infection, Recurrent bronchitis, Acute bronchiolitis, Infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Jun 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.
A phase III multicenter randomized double blind clinical trial will be conducted. After obtaining written consent the infant will be randomized, during the first two weeks of life, to a study group to receive either 400 IU or 1,000 IU / day of vitamin D to the year of age.
Baseline and all follow up visits (2, 6, and 12 months of life) will include anthropometric measurements and a questionnaire about health issues. A blood sample will be obtained at baseline for analysis of 25OH vitamin D, and at 6 and 12 months for analysis of 25 OH vitamin D, and calcium.
Healthy term born infants of appropriate size for gestational age will be included. We will need to include 359 children in each group.
The primary objective of the study is to decrease the proportion of infants with acute bronchitis during the first year of life by supplementation of 1,000 IU/day vitamin D. Secondary otcomes are: To check that the administration of 1,000 IU/day vitamin D decreases the proportion of infants with upper respiratory tract infections, the proportion of children under one year of age hospitalized for acute bronchiolitis, and the demand on the healthcare system due to respiratory infections and absences from work for parents and achieves a higher proportion of children with adequate blood levels 25 OH vitamin D.
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 |
|---|---|---|
| Vitamin D3 1000 IU/day | Experimental | Drug: Vitamin D3, Drug: PlaceboInfants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 1.000 IU/day during the first year of life, taking into account the vitamin D received with artificial milk |
| Vitamin D3 400 IU/day | Active comparator | Drug: Vitamin D3, Drug: PlaceboInfants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 400 IU/day during the first year of life, taking into account the vitamin D received with artificial milk |
Who may qualify
- Ages
- Up to 19 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy term born infants of appropriate size for gestational age
- Parents provide informed consent to participate
Key exclusion criteria (5 listed)
- Infants with small size for gestational age
- Infants with gestational age < 37 weeks
- Infants with congenital anomalies
- Infants with chronic gastrointestinal tract, liver, kidney, heart, or neurological diseases
- Infants with disorders of vitamin D or calcium metabolism or others inborn errors of metabolism
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 | Drug | Vitamin D3 1000 IU/day, Vitamin D3 400 IU/day |
| Placebo | Drug | Vitamin D3 1000 IU/day, Vitamin D3 400 IU/day |
Primary outcome
Percentage of children with acute bronchitis
Time frame: 1 year
Check that the administration of a vitamin D dose of 1,000 U / day decreases the percentage of children with acute bronchitis during the first year of life
1 secondary outcome
Number of episodes of upper respiratory infections reported by parents in the first year of life
Time frame: 1 year
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 22 Mar 2017.
- Background: PubMed 21187313Camargo CA Jr, Ingham T, Wickens K, Thadhani R, Silvers KM, Epton MJ, Town GI, Pattemore PK, Espinola JA, Crane J; New Zealand Asthma and Allergy Cohort Study Group. Cord-blood 25-hydroxyvitamin D levels and risk of respiratory infection, wheezing, and asthma. Pediatrics. 2011 Jan;127(1):e180-7. doi: 10.1542/peds.2010-0442. Epub 2010 Dec 27.
- Background: PubMed 21555499Belderbos ME, Houben ML, Wilbrink B, Lentjes E, Bloemen EM, Kimpen JL, Rovers M, Bont L. Cord blood vitamin D deficiency is associated with respiratory syncytial virus bronchiolitis. Pediatrics. 2011 Jun;127(6):e1513-20. doi: 10.1542/peds.2010-3054. Epub 2011 May 9.
- Background: PubMed 18030309Karatekin G, Kaya A, Salihoglu O, Balci H, Nuhoglu A. Association of subclinical vitamin D deficiency in newborns with acute lower respiratory infection and their mothers. Eur J Clin Nutr. 2009 Apr;63(4):473-7. doi: 10.1038/sj.ejcn.1602960. Epub 2007 Nov 21.
- Background: PubMed 20219962Urashima M, Segawa T, Okazaki M, Kurihara M, Wada Y, Ida H. Randomized trial of vitamin D supplementation to prevent seasonal influenza A in schoolchildren. Am J Clin Nutr. 2010 May;91(5):1255-60. doi: 10.3945/ajcn.2009.29094. Epub 2010 Mar 10.
- Background: PubMed 17344509Devereux G, Litonjua AA, Turner SW, Craig LC, McNeill G, Martindale S, Helms PJ, Seaton A, Weiss ST. Maternal vitamin D intake during pregnancy and early childhood wheezing. Am J Clin Nutr. 2007 Mar;85(3):853-9. doi: 10.1093/ajcn/85.3.853.
- Background: PubMed 17344501Camargo CA Jr, Rifas-Shiman SL, Litonjua AA, Rich-Edwards JW, Weiss ST, Gold DR, Kleinman K, Gillman MW. Maternal intake of vitamin D during pregnancy and risk of recurrent wheeze in children at 3 y of age. Am J Clin Nutr. 2007 Mar;85(3):788-95. doi: 10.1093/ajcn/85.3.788.
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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.
Antonio Moreno, MD, PhD study chair
Hospital Universitari Vall d'hebron Barcelona, Spain
1 site 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 D3 in people with Acute Bronchitis and Upper Respiratory Tract Infection, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 5 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 22 Mar 2017. 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 Spain. 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?
Percentage of children with acute bronchitis (time frame: 1 year). 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 NCT01875757, which also lists 6 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 22 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.