Upper Respiratory Tract InfectionsPhase 3MDARINCT02388516
Maternal Vitamin D for Acute Respiratory Infections in Infancy
A Phase 3 study testing Vitamin D3 in people with Upper Respiratory Tract Infections and Lower Respiratory Tract Infections, run by The Hospital for Sick Children at 1 site in Bangladesh.
Trial summary
There is a growing body of data suggesting that vitamin D modulates the host's immune response to acute respiratory infection (ARI). The primary aim of this study is to determine whether maternal vitamin D3 supplementation versus placebo decreases the incidence rate of microbiologically confirmed viral-associated ARI… Read more about this study
- Who is it for?
- Ages 1 day to 26 weeksHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections, Lower Respiratory Tract Infections
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,214 participants
- Where
- 1 siteBangladesh
- Study dates
- Dec 2014to 21 Aug 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 1 day to 26 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants born to women enrolled in the MDIG trial (NCT01924013).
- Maternal inclusion criteria (at time of enrolment) will be:
- At least 18 years of age
- 17 to 24 completed weeks of gestation
- Intends to permanently reside in the trial catchment area for at least 18 months
- Family plans to reside in catchment area for the first 6 months postnatal
- Provides written informed consent for participation
Who cannot join
- Mother withdrawn from MDIG trial prior to delivery
- Failure to provide consent for participation in sub-study
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangldesh
Dhaka
About this study
Official title: Maternal Vitamin D for Acute Respiratory Infections in Infancy (MDARI): a Nested Sub-study in a Randomized Controlled Trial of Vitamin D Supplementation During Pregnancy and Lactation in Dhaka, Bangladesh
There is a growing body of data suggesting that vitamin D modulates the host's immune response to acute respiratory infection (ARI). The primary aim of this study is to determine whether maternal vitamin D3 supplementation versus placebo decreases the incidence rate of microbiologically confirmed viral-associated ARI among infants in Dhaka, Bangladesh. Secondary outcomes include: A) incidence of ARI associated with specific major pathogens, B) incidence of clinical ARI (without the need for positive microbiology), and C) quantitative density of pneumococcal carriage. Infants will be followed from birth until 6 months of life. Among infants who meet at least one of the specific case definitions for ARI (see 'Detailed Description' section), nasal swab specimens will be collected. Respiratory samples will be analyzed by real-time polymerase chain reaction (qPCR) to identify a 7-virus panel (influenza A and B, respiratory syncytial virus, human metapneumovirus, adenovirus, and parainfluenza types 1, 2, and 3) plus quantitative density of S. pneumonia.
Read the detailed description
In this study, an acute respiratory infection (URTI and/or LRTI) has been clinically defined as:
- Upper respiratory tract infection (URTI)
A new-onset illness consisting of at least two of the following clinical criteria at any time during a surveillance week:
- Caregiver-reported cough;
- Caregiver-reported rhinorrhea;
- Caregiver-reported nasal congestion; and,
- Measured axillary temperature greater than or equal to 37.5°C.
- Lower respiratory tract infection (LRTI)
- New onset clinically-diagnosed LRTI:
- Caregiver-reported cough AND/OR difficulty breathing during a surveillance week; AND,
- Observed lower chest wall indrawing AND/OR elevated respiratory rate (60 breaths per minute or greater for infant up to 59 days of age, or 50 breaths per minute or greater for infant 60 days of age or older)
- Hospitalized LRTI
- Hospitalization with physician diagnosis of pneumonia or bronchiolitis
- Being tested
- Vitamin D3, Placebo
- Keywords
- Bangladesh, Vitamin D, Acute Respiratory Infections, Infancy, Pregnancy
- 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 D3Dietary supplement
Also called Cholecalciferol
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Prenatal Period 0 IU; Postpartum Period 0 IU (placebo) Overall: The Prenatal Period will start at enrolment (17-24 weeks gestation) and last until delivery. The Postpartum Period will last from delivery until 6 months postpartum. Receives: Dietary Supplement: Placebo |
| Group B | Experimental | Prenatal Period 4,200 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo) Receives: Dietary Supplement: Vitamin D3 |
| Group C | Experimental | Prenatal Period 16,800 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo) Receives: Dietary Supplement: Vitamin D3 |
| Group D | Experimental | Prenatal Period 28,000 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo) Receives: Dietary Supplement: Vitamin D3 |
| Group E | Experimental | Prenatal Period 28,000 IU/week of vitamin D3; Postpartum Period 28,000 IU/week Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI)
Measured: 0 to 6 months
Secondary outcomes (7)
ARI with microbiologically confirmed influenza A or B
Measured: 0 to 6 months
ARI with microbiologically confirmed RSV
Measured: 0 to 6 months
Clinical URTI and/or LRTI (i.e., no microbiological confirmation)
Measured: 0 to 6 months
Clinical URTI (i.e., no microbiological confirmation)
Measured: 0 to 6 months
Clinical LRTI (i.e., no microbiological confirmation)
Measured: 0 to 6 months
Quantitative S. pneumoniae nasal carriage density
Measured: 0 to 6 months
Pneumonia (non-severe) and severe pneumonia or very severe disease
Measured: 2 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 posted17 Mar 2015 (estimated)
- Study startDec 2014
- Primary completion21 Aug 2016
- Study completion21 Aug 2016
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 Upper 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
- 1,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Principal investigator, Daniel Roth, The Hospital for Sick Children
- Investigators
- Shaun K Morris, MD, MPH, Principal investigator, The Hospital for Sick ChildrenDaniel Roth, MD, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388516
- Sponsor's protocol ID
- 1000039072-ARI
- Acronym
- MDARI
- Status last verified
- Apr 2017
- First submitted
- 9 Mar 2015
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Taghivand M, Pell LG, Rahman MZ, Mahmud AA, Ohuma EO, Pullangyeum EM, Ahmed T, Hamer DH, Zlotkin SH, Gubbay JB, Morris SK, Roth DE. Effect of maternal vitamin D supplementation on nasal pneumococcal acquisition, carriage dynamics and carriage density in infants in Dhaka, Bangladesh. BMC Infect Dis. 2022 Jan 13;22(1):52. doi: 10.1186/s12879-022-07032-y.
PubMed 35026987Morris SK, Pell LG, Rahman MZ, Dimitris MC, Mahmud A, Islam MM, Ahmed T, Pullenayegum E, Kashem T, Shanta SS, Gubbay J, Papp E, Science M, Zlotkin S, Roth DE. Maternal vitamin D supplementation during pregnancy and lactation to prevent acute respiratory infections in infancy in Dhaka, Bangladesh (MDARI trial): protocol for a prospective cohort study nested within a randomized controlled trial. BMC Pregnancy Childbirth. 2016 Oct 13;16(1):309. doi: 10.1186/s12884-016-1103-9.
PubMed 27737646
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Vitamin D for Acute Respiratory Infections in Infancy (MDARI): a Nested Sub-study in a Randomized Controlled Trial of Vitamin D Supplementation During Pregnancy and Lactation in Dhaka, Bangladesh
- ClinicalTrials.gov ID
- NCT02388516
- Acronym / sponsor ID
- MDARI / 1000039072-ARI
- Keywords
- Bangladesh, Vitamin D, Acute Respiratory Infections, Infancy, Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,214 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Dec 2014
- Primary completion
- 21 Aug 2016 (actual)
- Study completion
- 21 Aug 2016 (actual)
- First posted
- 17 Mar 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.
There is a growing body of data suggesting that vitamin D modulates the host's immune response to acute respiratory infection (ARI). The primary aim of this study is to determine whether maternal vitamin D3 supplementation versus placebo decreases the incidence rate of microbiologically confirmed viral-associated ARI among infants in Dhaka, Bangladesh. Secondary outcomes include: A) incidence of ARI associated with specific major pathogens, B) incidence of clinical ARI (without the need for positive microbiology), and C) quantitative density of pneumococcal carriage. Infants will be followed from birth until 6 months of life. Among infants who meet at least one of the specific case definitions for ARI (see 'Detailed Description' section), nasal swab specimens will be collected. Respiratory samples will be analyzed by real-time polymerase chain reaction (qPCR) to identify a 7-virus panel (influenza A and B, respiratory syncytial virus, human metapneumovirus, adenovirus, and parainfluenza types 1, 2, and 3) plus quantitative density of S. pneumonia.
Detailed description
In this study, an acute respiratory infection (URTI and/or LRTI) has been clinically defined as:
- Upper respiratory tract infection (URTI)
A new-onset illness consisting of at least two of the following clinical criteria at any time during a surveillance week:
- Caregiver-reported cough;
- Caregiver-reported rhinorrhea;
- Caregiver-reported nasal congestion; and,
- Measured axillary temperature greater than or equal to 37.5°C.
- Lower respiratory tract infection (LRTI)
- New onset clinically-diagnosed LRTI:
- Caregiver-reported cough AND/OR difficulty breathing during a surveillance week; AND,
- Observed lower chest wall indrawing AND/OR elevated respiratory rate (60 breaths per minute or greater for infant up to 59 days of age, or 50 breaths per minute or greater for infant 60 days of age or older)
- Hospitalized LRTI
- Hospitalization with physician diagnosis of pneumonia or bronchiolitis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Dietary Supplement: PlaceboPrenatal Period 0 IU; Postpartum Period 0 IU (placebo) Overall: The Prenatal Period will start at enrolment (17-24 weeks gestation) and last until delivery. The Postpartum Period will last from delivery until 6 months postpartum. |
| Group B | Experimental | Dietary Supplement: Vitamin D3Prenatal Period 4,200 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo) |
| Group C | Experimental | Dietary Supplement: Vitamin D3Prenatal Period 16,800 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo) |
| Group D | Experimental | Dietary Supplement: Vitamin D3Prenatal Period 28,000 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo) |
| Group E | Experimental | Dietary Supplement: Vitamin D3Prenatal Period 28,000 IU/week of vitamin D3; Postpartum Period 28,000 IU/week |
Who may qualify
- Ages
- 1 day to 26 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infants born to women enrolled in the MDIG trial (NCT01924013).
- Maternal inclusion criteria (at time of enrolment) will be:
- At least 18 years of age
- 17 to 24 completed weeks of gestation
- Intends to permanently reside in the trial catchment area for at least 18 months
Key exclusion criteria (2 listed)
- Mother withdrawn from MDIG trial prior to delivery
- Failure to provide consent for participation in sub-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 D3Also: Cholecalciferol | Dietary supplement | Group B, Group C, Group D, Group E |
| Placebo | Dietary supplement | Group A |
Primary outcome
Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI)
Time frame: 0 to 6 months
7 secondary outcomes
ARI with microbiologically confirmed influenza A or B
Time frame: 0 to 6 months
ARI with microbiologically confirmed RSV
Time frame: 0 to 6 months
Clinical URTI and/or LRTI (i.e., no microbiological confirmation)
Time frame: 0 to 6 months
Clinical URTI (i.e., no microbiological confirmation)
Time frame: 0 to 6 months
Clinical LRTI (i.e., no microbiological confirmation)
Time frame: 0 to 6 months
Quantitative S. pneumoniae nasal carriage density
Time frame: 0 to 6 months
Pneumonia (non-severe) and severe pneumonia or very severe disease
Time frame: 2 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 Apr 2017.
- Derived from this study: PubMed 35026987Taghivand M, Pell LG, Rahman MZ, Mahmud AA, Ohuma EO, Pullangyeum EM, Ahmed T, Hamer DH, Zlotkin SH, Gubbay JB, Morris SK, Roth DE. Effect of maternal vitamin D supplementation on nasal pneumococcal acquisition, carriage dynamics and carriage density in infants in Dhaka, Bangladesh. BMC Infect Dis. 2022 Jan 13;22(1):52. doi: 10.1186/s12879-022-07032-y.
- Derived from this study: PubMed 27737646Morris SK, Pell LG, Rahman MZ, Dimitris MC, Mahmud A, Islam MM, Ahmed T, Pullenayegum E, Kashem T, Shanta SS, Gubbay J, Papp E, Science M, Zlotkin S, Roth DE. Maternal vitamin D supplementation during pregnancy and lactation to prevent acute respiratory infections in infancy in Dhaka, Bangladesh (MDARI trial): protocol for a prospective cohort study nested within a randomized controlled trial. BMC Pregnancy Childbirth. 2016 Oct 13;16(1):309. doi: 10.1186/s12884-016-1103-9.
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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.
Shaun K Morris, MD, MPH principal investigator
The Hospital for Sick Children
Daniel Roth, MD, PhD principal investigator
The Hospital for Sick Children
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 Upper Respiratory Tract Infections and Lower Respiratory Tract Infections, run by The Hospital for Sick Children at 1 site in Bangladesh.
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 7 inclusion and 2 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 Apr 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 Bangladesh. 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 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?
Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) (time frame: 0 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 NCT02388516, 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 Apr 2017.