Safety and Efficacy of Novasil Clay (Calcium Montmorillonite) in Children Exposed to Aflatoxin in Ejura-Sekyedumase District in Ghana

Justice Kumi, Regina Appiah-Opong, Dietrich Rein, Godfred Egbi, Enoch Aninagyei, Alex Boye, Desmond Omane-Acheampong

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

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.

Original languageEnglish
JournalGlobal Pediatric Health
Volume9
DOIs
Publication statusPublished - 2022
Externally publishedYes

Keywords

  • Aflatoxin
  • Children
  • Ghana
  • Novasil

Fingerprint

Dive into the research topics of 'Safety and Efficacy of Novasil Clay (Calcium Montmorillonite) in Children Exposed to Aflatoxin in Ejura-Sekyedumase District in Ghana'. Together they form a unique fingerprint.

Cite this