TY - JOUR
T1 - Safety and Efficacy of Novasil Clay (Calcium Montmorillonite) in Children Exposed to Aflatoxin in Ejura-Sekyedumase District in Ghana
AU - Kumi, Justice
AU - Appiah-Opong, Regina
AU - Rein, Dietrich
AU - Egbi, Godfred
AU - Aninagyei, Enoch
AU - Boye, Alex
AU - Omane-Acheampong, Desmond
N1 - Publisher Copyright:
© The Author(s) 2022.
PY - 2022
Y1 - 2022
N2 - Background. Aflatoxin levels are very high in animals and humans in places where cereals are poorly stored. In this study, Novasil was evaluated for safety and efficacy in children. Methods. Children (200) aged between 2 and 9 years were put into Novasil and placebo group. Participants received either 1.5 g of Novasil or calcium carbonate in their food. Urine samples were analyzed for AFM1 by HPLC, blood samples were assayed for complete blood count and chemistries. Results. Aflatoxin M1 levels in the Novasil treated group, significantly reduced to 60% compared to an increase of urine AFM1 in the placebo group. Hematological parameters did not change except for an increase in hemoglobin level in the Novasil group. Biochemical parameters remained unchanged except calcium ions. Glutathione levels in the Novasil increased, compared group to the placebo group. Conclusion. Novasil is safe, reduce aflatoxin bioavailability in humans while improving GSH antioxidant capacity as well. The trial has been registered with Pan African Clinical Trial Registry (www.pactr.org). A WHO registry for clinical trials with a unique identification number PACTR202202797930675.
AB - Background. Aflatoxin levels are very high in animals and humans in places where cereals are poorly stored. In this study, Novasil was evaluated for safety and efficacy in children. Methods. Children (200) aged between 2 and 9 years were put into Novasil and placebo group. Participants received either 1.5 g of Novasil or calcium carbonate in their food. Urine samples were analyzed for AFM1 by HPLC, blood samples were assayed for complete blood count and chemistries. Results. Aflatoxin M1 levels in the Novasil treated group, significantly reduced to 60% compared to an increase of urine AFM1 in the placebo group. Hematological parameters did not change except for an increase in hemoglobin level in the Novasil group. Biochemical parameters remained unchanged except calcium ions. Glutathione levels in the Novasil increased, compared group to the placebo group. Conclusion. Novasil is safe, reduce aflatoxin bioavailability in humans while improving GSH antioxidant capacity as well. The trial has been registered with Pan African Clinical Trial Registry (www.pactr.org). A WHO registry for clinical trials with a unique identification number PACTR202202797930675.
KW - Aflatoxin
KW - Children
KW - Ghana
KW - Novasil
UR - http://www.scopus.com/inward/record.url?scp=85138712257&partnerID=8YFLogxK
U2 - 10.1177/2333794X221121243
DO - 10.1177/2333794X221121243
M3 - Article
AN - SCOPUS:85138712257
SN - 2333-794X
VL - 9
JO - Global Pediatric Health
JF - Global Pediatric Health
ER -