Lower Respiratory Tract Infections, Upper Respiratory Tract Infections
Conditions
Keywords
Bangladesh, Vitamin D, Acute Respiratory Infections, Infancy, Pregnancy
Brief 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 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: A) 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. B) Lower respiratory tract infection (LRTI) 1. 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) 2. Hospitalized LRTI * Hospitalization with physician diagnosis of pneumonia or bronchiolitis
Interventions
DIETARY_SUPPLEMENTVitamin D3
DIETARY_SUPPLEMENTPlacebo
Sponsors
International Centre for Diarrhoeal Disease Research, Bangladesh
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 26 Weeks
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Mother withdrawn from MDIG trial prior to delivery * Failure to provide consent for participation in sub-study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) | 0 to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| ARI with microbiologically confirmed RSV | 0 to 6 months |
| Clinical URTI and/or LRTI (i.e., no microbiological confirmation) | 0 to 6 months |
| Clinical URTI (i.e., no microbiological confirmation) | 0 to 6 months |
| ARI with microbiologically confirmed influenza A or B | 0 to 6 months |
| Quantitative S. pneumoniae nasal carriage density | 0 to 6 months |
| Pneumonia (non-severe) and severe pneumonia or very severe disease | 2 to 6 months |
| Clinical LRTI (i.e., no microbiological confirmation) | 0 to 6 months |
Countries
Bangladesh
Outcome results
None listed