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Randomized Controlled Trial
. 2016 Oct 13;16(1):309.
doi: 10.1186/s12884-016-1103-9.

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

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Randomized Controlled Trial

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

Shaun K Morris et al. BMC Pregnancy Childbirth. .
Free PMC article


Background: Early infancy is a high-risk period for severe acute respiratory infection (ARI), particularly in low-income countries with resource-limited health systems. Lower respiratory tract infection (LRTI) is commonly preceded by upper respiratory infection (URTI), and often caused by respiratory syncytial virus (RSV), influenza and other common community-acquired viral pathogens. Vitamin D status is a candidate modifiable early-life determinant of the host antiviral immune response and thus may influence the risk of ARI-associated morbidity in high-risk populations.

Methods/design: In the Maternal Vitamin D for Infant Growth (MDIG) study in Dhaka, Bangladesh (NCT01924013), 1300 pregnant women are randomized to one of five groups: placebo, 4200 IU/week, 16,800 IU/week, or 28,000 IU/week from 2nd trimester to delivery plus placebo from 0-6 months postpartum; or, 28,000 IU/week prenatal and until 6-months postpartum. In the Maternal Vitamin D for ARI in Infancy (MDARI) sub-study nested within the MDIG trial, trained personnel conduct weekly postnatal home visits to inquire about ARI symptoms and conduct a standardized clinical assessment. Supplementary home visits between surveillance visits are conducted when caregivers make phone notifications of new infant symptoms. Mid-turbinate nasal swab samples are obtained from infants who meet standardized clinical ARI criteria. Specimens are tested by polymerase chain reaction (PCR) for 8 viruses (influenza A/B, parainfluenza 1/2/3, RSV, adenovirus, and human metapneumovirus), and nasal carriage density of Streptococcus pneumoniae. The primary outcome is the incidence rate of microbiologically-positive viral ARI, using incidence rate ratios to estimate between-group differences. We hypothesize that among infants 0-6 months of age, the incidence of microbiologically-confirmed viral ARI will be significantly lower in infants whose mothers received high-dose prenatal/postpartum vitamin D supplements versus placebo. Secondary outcomes include incidence of ARI associated with specific pathogens (influenza A or B, RSV), clinical ARI, and density of pneumococcal carriage.

Discussion: If shown to reduce the risk of viral ARI in infancy, integration of maternal prenatal/postpartum vitamin D supplementation into antenatal care programs in South Asia may be a feasible primary preventive strategy to reduce the burden of ARI-associated morbidity and mortality in young infants.

Trial registration: NCT02388516 , registered March 9, 2015.

Keywords: Acute respiratory infection; Bangladesh; Infant; Influenza; Pneumonia; Pregnancy; Respiratory syncytial virus; Streptococcus pneumoniae; Vitamin D.


Fig. 1
Fig. 1
Maternal Vitamin D Acute Respiratory Infection (MDARI) trial flow diagram

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