Study protocol to assess aflatoxin M1 health risks versus benefits of dairy consumption in Ethiopian children: an epidemiological trial and risk-benefit analysis.

Introduction: In Sidama, Ethiopia, animal-source foods can be difficult to access. Milk has important nutrients for child growth, but carries the risk of aflatoxin M (AFM) contamination. AFM is a metabolite of the mycotoxin aflatoxin B (AFB) in dairy feed; cows secrete AFM in milk when their feed contains AFB produced by fungi in maize, nuts and oilseeds. It is unknown whether AFM compromises child growth and health.

Methods And Analysis: This protocol paper describes our study in Sidama to determine the impact of milk consumption and AFM on child growth in the first 18 months of life. We will collect baseline and end-line data on dairy production, socioeconomic and nutritional factors of 1000 dairy-owning households with children ages 6-18 months at baseline; and gather samples of milk and dairy feed and child anthropometrics. We will conduct phone interviews every 6 months to ascertain changes in practices or child health. Dairy feed will be tested for AFB; milk for AFM, pathogens and nutrients. Controlling for herd size, socioeconomic, nutritional and behavioural factors, we will determine the association between child anthropometrics and milk consumption, as well as AFM exposure. We will examine whether AFM exposure affects child growth in the first 18 months of life, and weigh the benefits and risks of milk consumption.

Ethics And Dissemination: The protocol is approved by the Institutional Review Boards of the Ethiopian Public Health Institute (EPHI-IRB-481-2022), Michigan State University (STUDY00007996) and International Food Policy Research Institute (DSGD-23-0102). Written informed consent will be obtained from all participants, who may withdraw from the study at any time. Confidentiality of collected data will be given high priority during each stage of data handling. The study's findings will be disseminated through stakeholder workshops, local and international conferences, journal articles and technical reports.