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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,214
- 试验地点
- 1
- 主要终点
- Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 26 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Mother withdrawn from MDIG trial prior to delivery
- •Failure to provide consent for participation in sub-study
结局指标
主要结局
Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI)
时间窗: 0 to 6 months
次要结局
- 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)
- Clinical LRTI (i.e., no microbiological confirmation)(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)
- ARI with microbiologically confirmed influenza A or B(0 to 6 months)
- ARI with microbiologically confirmed RSV(0 to 6 months)
研究者
Daniel Roth
Clinician-Scientist
The Hospital for Sick Children