Short-Term Safety and Efficacy of Calcium Montmorillonite Clay (UPSN) in Children

作者:Mitchell Nicole J; Kumi Justice; Aleser Mildred; Elmore Sarah E; Rychlik Kristal A; Zychowski Katherine E; Romoser Amelia A; Phillips Timothy D; Ankrah Nii Ayi*
来源:The American Journal of Tropical Medicine and Hygiene, 2014, 91(4): 777-785.
DOI:10.4269/ajtmh.14-0093

摘要

Recently, an association between childhood growth stunting and aflatoxin (AF) exposure has been identified. In Ghana, homemade nutritional supplements often consist of AF-prone commodities. In this study, children were enrolled in a clinical intervention trial to determine the safety and efficacy of Uniform Particle Size NovaSil (UPSN), a refined calcium montmorillonite known to be safe in adults. Participants ingested 0.75 or 1.5 g UPSN or 1.5 g calcium carbonate placebo per day for 14 days. Hematological and serum biochemistry parameters in the UPSN groups were not significantly different from the placebo-controlled group. Importantly, there were no adverse events attributable to UPSN treatment. A significant reduction in urinary metabolite (AFM(1)) was observed in the high-dose group compared with placebo. Results indicate that UPSN is safe for children at doses up to 1.5 g/day for a period of 2 weeks and can reduce exposure to AFs, resulting in increased quality and efficacy of contaminated foods.