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

Am J Trop Med Hyg. 2014 Oct;91(4):777-85. doi: 10.4269/ajtmh.14-0093. Epub 2014 Aug 18.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Aflatoxins / adverse effects*
  • Aflatoxins / urine
  • Aluminum Silicates
  • Bentonite / administration & dosage*
  • Bentonite / adverse effects
  • Calcium / administration & dosage*
  • Calcium / adverse effects
  • Child
  • Child, Preschool
  • Clay
  • Double-Blind Method
  • Environmental Exposure
  • Female
  • Food Contamination / prevention & control*
  • Food Safety
  • Ghana
  • Humans
  • Male
  • Minerals / blood
  • Treatment Outcome

Substances

  • Aflatoxins
  • Aluminum Silicates
  • Minerals
  • Bentonite
  • Calcium
  • Clay