Safety and Efficacy of Calcium Montmorillonite Clay (Novasil) in Children at Risk of Aflatoxin Related Diseases in Ejura Sekyedumase District, Ghana

Abstract

The use of novasil clay as an intervention technique to prevent aflatoxin poisoning in animals and humans has proven to be effective. In this study, evaluation of the safety and efficacy of novasil clay was carried out in 60 days in children in the Ejura Sekyedumase District, Ashanti Region, Ghana. Also, the relationship between growth indicators and aflatoxin in children was investigated. Stratified cluster sampling was used to recruit participants into the study. Healthy (200 children) within the age bracket of 2-9 years were put into two arms of study, which include 100 test group and 100 placebo group. One arm received 1.5g of novasil (test material) whiles the other arm received calcium sulphate as placebo. Full blood count, reduced glutathione, liver, kidney biomarkers, aflatoxin M1 and growth indicators were measured. Out of the total population of 200 children, 26 (13%) were Stunting 6 (3 %) were underweight. Change in serum biochemistry parameters and calcium levels between the placebo and novasil groups were not statistically significant (P > 0.05). At the end of the treatment cycle, reduced blood glutathione levels increased significantly in the novasil treated group. Aflatoxin M1 excretion in urine showed a significant reduction (P = 0.033) from a mean of 811.2 AFM1pg/mg creatinine to 329.1AFM1pg/mg creatinine at the end of the novasil treatment, representing a 60.7 % reduction. The placebo group demonstrated a significant increase (P = 0.02) of 44 % AFM1 excretion in urine from a mean of 801.3 to 1801.2 AFM1pg/mg creatinine. At the end of the 60 day intervention study, novasil was safe with no adverse effect and caused a reduction of aflatoxin bioavailability in children.