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

## TL;DR

This study will assess the health risks and benefits of milk consumption in Ethiopian children, focusing on aflatoxin M1 contamination and its impact on growth.

## Contribution

The study introduces a novel epidemiological trial to evaluate the risk-benefit balance of dairy consumption in a context of aflatoxin contamination.

## Key findings

- Baseline and end-line data will be collected from 1000 households to assess dairy consumption and child growth.
- AFM1 exposure and its association with child anthropometrics will be analyzed while controlling for socioeconomic and nutritional factors.

## Abstract

In Sidama, Ethiopia, animal-source foods can be difficult to access. Milk has important nutrients for child growth, but carries the risk of aflatoxin M1 (AFM1) contamination. AFM1 is a metabolite of the mycotoxin aflatoxin B1 (AFB1) in dairy feed; cows secrete AFM1 in milk when their feed contains AFB1 produced by Aspergillus fungi in maize, nuts and oilseeds. It is unknown whether AFM1 compromises child growth and health.

This protocol paper describes our study in Sidama to determine the impact of milk consumption and AFM1 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 AFB1; milk for AFM1, 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 AFM1 exposure. We will examine whether AFM1 exposure affects child growth in the first 18 months of life, and weigh the benefits and risks of milk consumption.

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.