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
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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DOI：
10.1186/s12884-016-1103-9
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发表时间：
2016-10-13
影响因子：
3.1
通讯作者：
Roth, Daniel E.
中科院分区：
文献类型：
--
作者：
Morris, Shaun K.;Pell, Lisa G.;Roth, Daniel E.
背景资料：婴儿早期是严重急性呼吸道感染的高风险时期，特别是在卫生系统资源有限的低收入国家。下呼吸道感染（LRTI）通常在上呼吸道感染（URTI）之前发生，并且通常由呼吸道合胞病毒（RSV）、流感和其他常见的社区获得性病毒病原体引起。维生素D状态是宿主抗病毒免疫应答的一个可改变的早期生命决定因素，因此可能影响高危人群中ARI相关发病率的风险。方法/设计：在孟加拉国达卡进行的母体维生素D促进婴儿生长（MDIG）研究中，（NCT 01924013）中，将1300名孕妇随机分为五组之一：安慰剂，4200 IU/周、16，800 IU/周或28，000 IU/周，从第二个三个月到分娩加安慰剂，从产后0-6个月;或产前28，000 IU/周，直至产后6个月。在MDIG试验中嵌套的母体维生素D治疗婴儿ARI（MDARI）子研究中，经过培训的人员每周进行一次产后家访，以询问ARI症状并进行标准化临床评估。当护理人员电话通知新的婴儿症状时，在监测访问之间进行补充家访。中鼻甲鼻拭子样品从符合标准化临床ARI标准的婴儿获得。通过聚合酶链反应（PCR）检测标本中的8种病毒（甲型/B流感病毒、副流感病毒1/2/3、RSV、腺病毒和人偏肺病毒）和肺炎链球菌的鼻携带密度。主要结果是微生物学阳性病毒性ARI的发生率，使用发生率比估计组间差异。我们假设，在0-6个月大的婴儿中，与安慰剂相比，母亲接受高剂量产前/产后维生素D补充剂的婴儿的微生物学证实的病毒性ARI的发病率将显著降低。次要结局包括与特定病原体相关的ARI发生率（流感A或B，RSV），临床ARI，和肺炎球菌携带密度。如果能降低婴儿期病毒性ARI的风险，在南亚，将产妇产前/产后维生素D补充纳入产前保健计划可能是减少ARI负担的可行的一级预防策略，相关的发病率和死亡率的幼儿。
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.