Phillips Erica, Ngure Francis M, Kassim Neema, Turner Paul C, Makule Edna, Smith Laura E, Makori Nyabasi, Cramer Benedikt, Humpf Hans-Ulrich, Nelson Rebecca J, Stoltzfus Rebecca J
Division of Nutritional Sciences, Cornell University, Ithaca, NY, United States; University of Wisconsin-Madison, Department of Nutritional Sciences, Madison, Wisconsin, United States.
Division of Nutritional Sciences, Cornell University, Ithaca, NY, United States.
Am J Clin Nutr. 2025 Feb;121(2):333-342. doi: 10.1016/j.ajcnut.2024.11.022. Epub 2024 Nov 26.
Linear growth faltering continues to negatively affect children in low- and middle-income countries and is associated with poor cognitive, developmental, and educational outcomes. Laboratory and observational data suggest that aflatoxin (AF) is a contributor to stunting.
The Mycotoxin Mitigation Trial was a cluster-randomized, community-based 2-group trial conducted in Kongwa District, Tanzania, between 2018 and 2020. The trial assessed whether a 12-mo intervention to reduce AF consumption increased length-for-age z-scores (LAZ) at 18 mo.
Low-AF maize and groundnut flours were provided to the intervention group each month; skin lotion was distributed to the control group monthly. Infant and young child feeding education was delivered equally in 52 health facilities (clusters). Anthropometry and the AF blood biomarker serum AF-albumin (AF-alb) were assessed at 6, 12, and 18 mo of age. Outcomes were analyzed as intention-to-treat and per-protocol using linear mixed-effects models.
Two thousand eight hundred forty-two maternal-infant dyads were recruited into the study. The intervention did not create a contrast in AF-alb. At 18 mo, 36% (n = 186/520) of infants had detectable levels of AF-alb compared with 54% (n = 195/364) at baseline, with no difference between groups. Mean LAZ in the intervention group at 18 mo was -1.83 (n = 1231, 95% CI: -1.93, -1.73) compared to -1.90 (n = 1287, 95% CI: -1.99, -1.82) in the control group (P = 0.28).
An intervention to reduce AF exposure did not alter AF-alb nor anthropometric measures between treatment groups. Drought and agricultural data indicated less favorable conditions for toxin production, resulting in low levels of exposure in both trial arms. Annual, seasonal, and geographic heterogeneity of AF contamination make it difficult to study in an ethically designed trial. Our formative research and early trial data indicate that stunting and intermittent AF exposure continue to be a problem in this region. However, the low-AF exposure levels during the trial led to inconclusive results.
NCT03940547 (ClinicalTrials.org).
在低收入和中等收入国家，线性生长发育迟缓持续对儿童产生负面影响，并与认知、发育和教育不良后果相关。实验室和观察数据表明，黄曲霉毒素（AF）是导致发育迟缓的一个因素。
黄曲霉毒素缓解试验是一项于2018年至2020年在坦桑尼亚孔瓜区进行的整群随机、基于社区的两组试验。该试验评估了为期12个月的减少AF摄入量的干预措施是否会提高18个月时的年龄别身长Z评分（LAZ）。
每月向干预组提供低AF的玉米粉和花生粉；每月向对照组分发护肤液。在52个卫生设施（群组）中平等地开展婴幼儿喂养教育。在6、12和18月龄时评估人体测量指标以及AF血液生物标志物血清AF-白蛋白（AF-alb）。使用线性混合效应模型按意向性分析和符合方案分析对结果进行分析。
2842对母婴二元组被纳入研究。干预措施并未使AF-alb出现差异。在18月龄时，36%（n = 186/520）的婴儿AF-alb水平可检测到，而基线时为54%（n = 195/364），两组之间无差异。干预组18月龄时的平均LAZ为-1.83（n = 1231，95%CI：-1.93，-1.73），对照组为-1.90（n = 1287，95%CI：-1.99，-1.82）（P = 0.28）。
减少AF暴露的干预措施未改变治疗组之间的AF-alb及人体测量指标。干旱和农业数据表明毒素产生的条件不太有利，导致两个试验组的暴露水平都较低。AF污染的年度性、季节性和地理异质性使得在一项设计符合伦理的试验中进行研究变得困难。我们的形成性研究和早期试验数据表明，发育迟缓和间歇性AF暴露在该地区仍然是一个问题。然而，试验期间低AF暴露水平导致结果不明确。
NCT03940547（ClinicalTrials.org）。
