Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44,567
- 试验地点
- 2
- 主要终点
- Infant Mortality Through 6 mo of Age
研究概览
简要总结
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh.
详细描述
Maternal deficiency in multiple essential micronutrients is likely to be a major public health problem in low-income countries. Supplementing mothers with certain individual micronutrients has been shown to confer health benefits, although the evidence is not clear for multiple micronutrients. We aim to test, in a cluster-randomized, double-masked, controlled trial whether giving a daily multiple micronutrient supplement (similar in composition to the UNICEF antenatal supplement) will enhance infant survival and birth outcomes such as birth weight and gestational duration in a rural population in Bangladesh. Over the duration of 2-3 years a community-surveillance in the northwestern, rural Districts of Gaibandha and Southern Rangpur, the trial plans to identify and recruit 45,000 pregnant women based on 5-weekly histories of amenorrhea confirmed by urine-testing, and supplement them with either a multiple micronutrient supplement or an iron-folic acid supplement (as the standard of care control for pregnancy) and monitor pregnancy health, birth outcomes and vital status and health of liveborn infants through 6 months of age. In a ~3% sub-sample of mothers, additional measures of nutritional and health status will be evaluated in the 1st and 3rd trimesters of pregnancy, and at 3 months postpartum (with infants), that include anthropometric and body composition (bioelectrical impedance) assessment, collection of biospecimens (eg, phlebotomy and breast milk sampling for micronutrient and other analyte concentration determinations), and other clinical assessments. The trial will generate evidence from which to examine the safety and efficacy of an antenatal through postnatal maternal micronutrient supplement intervention in order to inform and guide antenatal nutrition policies and programs in South Asia.
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
- 12 Years 至 45 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant and consents to participate
排除标准
- •Not interviewed for consent within 12 consecutive weeks after being ascertained as pregnant by urine testing
研究组 & 干预措施
1
Iron (27 mg) and folic acid (600 ug)
干预措施: Iron (27 mg) - folic acid (600 ug) (Dietary Supplement)
2
Multiple micronutrient
干预措施: Multiple micronutrient (Dietary Supplement)
结局指标
主要结局
Infant Mortality Through 6 mo of Age
时间窗: 6-months post-birth
Infant Mortality to Age 6 months (180 days from birth)
次要结局
- Low Birth Weight(Measured at delivery/birth)
- Neonatal Mortality(1 month post-birth)
- Preterm Birth(Up to 37 weeks of gestation)
- Very Pre-term(Between 27 and 33 weeks of gestation)
- Small for Gestation Age(At delivery/birth)
- Post-neonatal Mortality(1-6 months post-birth)
- Extremely Pre-term(Up to 28 weeks of gestation)
- Moderate to Late Preterm(Between 31 and 38 weeks of gestation)
- Still Birth Rates(24 weeks gestation to delivery)
