Sanitation Hygiene Infant Nutrition Efficacy (SHINE)
Sub-study with the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Characterizing Pregnancy Exposure to Multiple Mycotoxins and its Relation to Birth Outcomes (Zimbabwe)
The SHINE Trial, funded by the Bill & Melinda Gates Foundation, is a community-based trial in rural Zimbabwe recruiting women during the first trimester of pregnancy to investigate the independent and combined effects of improved water, sanitation and hygiene and/or improved infant feeding on child stunting and anemia at 18 months of age. Birth outcomes such as miscarriage, stillbirth, prematurity, small-for-gestational age and stunted-for-gestational age are being measured, and there is strong evidence that mycotoxin exposures are prevalent and significant in this study population. Mycotoxins (including AF, FUM and DON) pose a threat to the safety of the global food supply, and may adversely affect the health of mothers and the health and development of their children. HRCI is supporting a sub-study within the larger SHINE trial to characterize pregnancy exposure to multiple mycotoxins and its relation to birth outcomes in SHINE. The over-arching hypothesis is that AF exposure, alone or in combination with FUM and DON, is an important cause of adverse birth outcomes globally.
The specific study aims are as follows:
- To describe the prevalence and severity of multiple mycotoxin exposures in a large representative sample of pregnant women in rural Zimbabwe.
- To characterize the relationship between maternal serum aflatoxin-albumin concentration during pregnancy and adverse birth outcomes preterm birth, low birth weight (LBW), small-for-gestational age (SGA) and short-for-gestational age in HIV-negative mothers. Pregnancy loss will also be explored as an outcome variable, but with less robust statistical power.
- To explore the joint exposures of FUM, DON and AF in relation to risk of preterm birth.
This sub-study will generate novel knowledge about the burden of multiple mycotoxins (AF, FUM, DON) during pregnancy and the potential contribution of mycotoxin exposure to adverse birth outcomes. Our long-term goal is to understand the effect of mycotoxin exposure on maternal and child health in Zimbabwe and by doing so, to inform the development of more effective child health interventions and food safety policy globally. Preliminary results show that AFM1 was detected in 30% of pregnant women (median of exposed, 162.5 pg AFM1/mg creatinine; range 30-6046 pg AFM1/mg). Lab analysis and data analysis are ongoing.