Short-term safety and efficacy of calcium montmorillonite clay (UPSN) in children

Abstract

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 (AFM1) 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.

Figure 1.

Correlation of log-transformed total bilirubin and log-transformed AFM₁ values for all participants at day 0.

Figure 2.

Comparison of urinary AFM₁ levels for placebo and low- and high-dose treatment groups. AFM₁ data for each group were pooled for days 7 and 15. *Indicates statistical significance (P < 0.05).