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 and Childbirth

Study Protocol

Abdullah Mahmud¹  Michelle C. Dimitris²  Lisa G. Pell²  Eszter Papp²  Tahmid Kashem³  M. Munirul Islam³  Tahmeed Ahmed³  Shaila S. Shanta³  Eleanor Pullenayegum⁴  Stanley Zlotkin⁵  Daniel E. Roth⁵  Shaun K. Morris⁶  Michelle Science⁷  Jonathan Gubbay⁸  Mohammed Ziaur Rahman⁹ 

[1] Centre for Child and Adolescent Health, icddr,b, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, 1212, Dhaka, Bangladesh;Centre for Global Child Health, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada;Centre for Nutrition and Food Security, icddr,b, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, 1212, Dhaka, Bangladesh;Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada;Department of Paediatrics, University of Toronto and the Hospital for Sick Children, 555 University Avenue, Toronto, ON, Canada;Centre for Global Child Health, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada;Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada;Department of Paediatrics, University of Toronto and the Hospital for Sick Children, 555 University Avenue, Toronto, ON, Canada;Centre for Global Child Health, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada;Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada;Division of Infectious Diseases, Hospital for Sick Children, 555 University Avenue, M5G1X8, Toronto, ON, Canada;Department of Paediatrics, University of Toronto and the Hospital for Sick Children, 555 University Avenue, Toronto, ON, Canada;Division of Infectious Diseases, Hospital for Sick Children, 555 University Avenue, M5G1X8, Toronto, ON, Canada;Department of Paediatrics, University of Toronto and the Hospital for Sick Children, 555 University Avenue, Toronto, ON, Canada;Public Health Ontario, 661 University Ave., Toronto, ON, Canada;Zoonotic Diseases Research Group, Centre for Communicable Diseases, icddr,b, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, 1212, Dhaka, Bangladesh;

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

DOI  :  10.1186/s12884-016-1103-9

 received in 2016-02-16, accepted in 2016-10-08,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundEarly 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/DesignIn 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.DiscussionIf 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 registrationNCT02388516, registered March 9, 2015.

【 授权许可】

CC BY   
© The Author(s). 2016