International Centre for Diarrhoeal Disease Research, Bangldesh
Dhaka, Bangladesh
NCT Number: NCT02388516
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.
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All sexes
Interventional
Phase 3
Dhaka, Bangladesh
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:
B) Lower respiratory tract infection (LRTI)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Cholecalciferol
Time frame: 0 to 6 months
Time frame: 0 to 6 months
Time frame: 0 to 6 months
Time frame: 0 to 6 months
Time frame: 0 to 6 months
Time frame: 0 to 6 months
Time frame: 0 to 6 months
Time frame: 2 to 6 months
The Hospital for Sick Children
Other
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
Acronym: MDARI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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