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Conventional chemotherapy has only limited efficacy, suffers from non-specific toxicity and the induction of chemoresistance. A WHO registry for clinical trials with a unique identification number PACTR202202797930675.Ĭancer remains one of the deadliest diseases, and its effective diagnosis and treatment remains challenging therefore, progress in earlier detection and improved therapeutics are urgently required. The trial has been registered with Pan African Clinical Trial Registry ( ). Novasil is safe, reduce aflatoxin bioavailability in humans while improving GSH antioxidant capacity as well. Glutathione levels in the Novasil increased, compared group to the placebo group. Biochemical parameters remained unchanged except calcium ions. Hematological parameters did not change except for an increase in hemoglobin level in the Novasil group. Aflatoxin M1 levels in the Novasil treated group, significantly reduced to 60% compared to an increase of urine AFM1 in the placebo group. Urine samples were analyzed for AFM1 by HPLC, blood samples were assayed for complete blood count and chemistries. Participants received either 1.5 g of Novasil or calcium carbonate in their food. Children (200) aged between 2 and 9 years were put into Novasil and placebo group. In this study, Novasil was evaluated for safety and efficacy in children. Aflatoxin levels are very high in animals and humans in places where cereals are poorly stored. 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.īackground. A significant reduction in urinary metabolite (AFM1) was observed in the high-dose group compared with placebo.
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Importantly, there were no adverse events attributable to UPSN treatment. Hematological and serum biochemistry parameters in the UPSN groups were not significantly different from the placebo-controlled group. Participants ingested 0.75 or 1.5 g UPSN or 1.5 g calcium carbonate placebo per day for 14 days. 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. In Ghana, homemade nutritional supplements often consist of AF-prone commodities. Recently, an association between childhood growth stunting and aflatoxin (AF) exposure has been identified.
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