Relationship Between Maternal Exposure to Mycotoxins, Birth Outcomes and Stunting in Infants: A Birth Cohort Study in Nepal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,675
- 主要终点
- Change in Height for Age Z-scores (HAZ)
研究概览
简要总结
The study focuses on the causal relationship between mycotoxin exposure (particularly aflatoxin B1), birth outcomes, and height for age among young children in Nepal. Previous studies have shown a strong association of stunting with mycotoxin exposure yet causality has not been proven. Thus, this study will provide a better understanding of the association between maternal and/or early life mycotoxin exposure (rates in the blood and breast milk) and infant and young child growth. This information is essential if we are to more fully understand and effectively address the high rates of stunting in Asia.
详细描述
In 2012, a research prioritization meeting organized by IFPRI and the Bill and Melinda Gates Foundation on food-borne toxins concluded, "While there is solid association of stunting with exposure to mycotoxins, the causality has not been proven and the percentage of stunting attributable to mycotoxins in general or to specific mycotoxins is not known." (IFPRI/BMGF 2012) In other words, the extent of the problem, although widely suspected, has been poorly documented and the biological mechanisms thought to be involved remain poorly understood.
To contribute to a better understanding of the mycotoxin-stunting relationship, the Feed the Future Feed the Future Nutrition Innovation Lab-Asia proposes to explore the impact of mycotoxins, with a focus on mycotoxins on child nutrition in Nepal. Through its PoSHAN study, the Nutrition Innovation Lab-Asia is currently undertaking research in Nepal in collaboration with the Child Health Division of the Ministry of Health and Population and multiple local partners on how investments in agriculture can achieve significant impacts on maternal and child nutrition, and on demonstrating how large-scale programs best incorporate such evidence into cost-effective multi-sectoral interventions. Adding a study component on food safety (mycotoxin contamination of the food supply) will significantly enhance our understanding of nutrition outcomes linked to investments in agriculture. As noted by participants of the IFPRI/BMGF (2012) meeting, "only 35% of stunting of children can be attributed to known factors". This leaves room for research to uncover other suspected contributors to the world's huge nutrition problems, which could then lead testable recommendations for innovative interventions to address newly identified factors. The team will assess current mycotoxin risk so that potential mitigation strategies can be developed.
Given the significant statistical associations shown between mycotoxin exposure in children and height gain in infants and young children, the Nutrition Innovation Lab-Asia will undertake an mycotoxin birth cohort study to further the understanding of the causal relationship between past and current mycotoxin exposure (maternal and infant), birth outcomes and length-for-age in Nepali infants and young children. The study will also seek to validate the use of low cost data collection methods (e.g. dried blood spots versus venous blood samples) for mycotoxin analysis.
The specific aims of this study are:
- To examine the relationship of maternal mycotoxin exposure in pregnancy and birth outcomes, including infant birth weight.
- To examine the relationship of exposure to mycotoxin of infants through breast milk and their linear growth.
- To examine the relationship of exposure to mycotoxin through complementary feeding and linear growth.
- To enumerate the relative contributions of maternal and infant mycotoxin exposures in impairing linear growth, controlling for other potential explanatory factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 49 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women and adolescent girls (less than 30 weeks gestation)
- •Aged 16-49 years
- •Living in the study area
- •Intends to reside in the study area through the study period
- •Intends to deliver in the study area
- •Provides informed consent herself or through a legal guardian
- •Live Birth
- •Single Birth
排除标准
- •Severely malnourished mother <17.5 cm
- •Severely anemic mother hemoglobin<7 g/dL
- •Pregnancy induced hypertension
- •Congenital anomalies
- •Very low birth weight <1500 g
- •Respiratory distress syndrome
- •Severe malnutrition infant ≤-3 WFH z-score (3 months), <11.5 cm MUAC or edema
- •Severe anemia infant (hemoglobin<7 g/dL)
- •Fetal loss
- •Early termination of pregnancy
- •Still births
- •Infant death
- •Relocation of household
结局指标
主要结局
Change in Height for Age Z-scores (HAZ)
时间窗: Measured at birth and when infant turns 3, 6, 9, 12, 18 and 24 months of age
Height for Age Z-scores based on the World Health Organization's 2006 Child Growth Standards, HAZ \< -6 and \> 6
次要结局
- Fumonisin B, Deoxynivalenol (DON) (urine)(Measured when infant turns 18 months of age)
- Aflatoxin B1 (serum)(Measured during pregnancy)
- Change in infant aflatoxin B1(Measured when infant turns 3, 6, 12 and 18 months of age)
- Ochratoxin A (serum)(Measured when infant turns 18 months of age)
- Aflatoxin M1 (breast milk)(Measured when infant is 3 months of age)
- Low birth weight(Measured at birth)
研究者
Patrick Webb
Alexander McFarlane Professor of Nutrition
Tufts University
