Prenatal ochratoxin A exposure, birth outcomes and infant growth in rural Burkina Faso: a human biomonitoring sub-study from the MISAME-III trial

Mycotoxin exposure during pregnancy has been associated with adverse birth outcomes and poor infant growth in low- and middle-income countries. We assessed multiple biomarkers and metabolites of exposure to mycotoxins during pregnancy and their associations with birth outcomes and infant growth in 305 pregnant participants, between 30 and 34 completed weeks of gestation, in rural Burkina Faso. In this study, whole blood microsamples were analyzed for mycotoxin concentrations using ultra-performance liquid chromatography coupled to tandem mass spectrometry. Unadjusted and adjusted associations between mycotoxin exposure, and birth outcomes and infant growth at 6 months were estimated using linear regression models for continuous outcomes and linear probability models with robust variance estimation for binary outcomes. Infant growth trajectories from birth to 6 months were compared by exposure status using mixed-effects models with random intercept for the individual infant and random slope for the age of the infant. Ochratoxin A (OTA) exposure was detected in 50.8% of the study participants, with aflatoxin G1, aflatoxin M1, cyclopiazonic acid, deoxynivalenol and T-2-toxin being detected in the range of 0.33% and 2.31% of the population. We found no statistically significant (all p ≥ 0.05) associations between OTA exposure, and birth outcomes and infant growth. Despite this, the findings indicate a significant presence of ochratoxin A among pregnant participants. Public health policies and nutrition-sensitive interventions must ensure that OTA exposure is reduced in Burkina Faso. ### Competing Interest Statement The main trial work of MISAME-III received support from the Bill & Melinda Gates Foundation (OPP1175213). The mycotoxins sampling and analysis was supported by Fonds Wetenschappelijk Onderzoek (project No G085921N). MDB received support from the European Research Council through the European Union Horizon 2020 research and innovation program (grant agreement No 946192, HUMYCO). The funders did not participate in the study's design and execution, data collection, management, analysis, or interpretation, nor were they involved in the preparation, review, or approval of the manuscript. ### Funding Statement The main trial work of MISAME-III received support from the Bill & Melinda Gates Foundation (OPP1175213). The mycotoxins sampling and analysis was supported by Fonds Wetenschappelijk Onderzoek (project No G085921N). MDB received support from the European Research Council through the European Union Horizon 2020 research and innovation program (grant agreement No 946192, HUMYCO). The funders did not participate in the study design and execution, data collection, management, analysis, or interpretation, nor were they involved in the preparation, review, or approval of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study protocol received approval from the Ethical Committee of Ghent University Hospital in Belgium (B670201734334) and the Ethical Committee of Institut de Recherche en Sciences de la Santé in Burkina Faso (50-2020/CEIRES). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Due to the sensitive nature of the data, access to the data will be facilitated through a data-sharing agreement. For inquiries, please reach out to carl.lachat@ugent.be and marthe.deboevre@ugent.be. Additionally, supporting study documents such as the study protocol and questionnaires can be accessed publicly on the website: https://misame3.ugent.be (accessed on 07 December 2023).