title: Short-term safety and efficacy of calcium montmorillonite clay (UPSN) in children.
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.
authors.affiliation: College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, Texas; Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana; Ejura-Sekyedumase District Hospital, Ejura, Ghana.
authors.forename: Nicole J
authors.initials: NJ
authors.lastname: Mitchell
authors.affiliation: College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, Texas; Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana; Ejura-Sekyedumase District Hospital, Ejura, Ghana.
authors.forename: Justice
authors.initials: J
authors.lastname: Kumi
authors.affiliation: College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, Texas; Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana; Ejura-Sekyedumase District Hospital, Ejura, Ghana.
authors.forename: Mildred
authors.initials: M
authors.lastname: Aleser
authors.affiliation: College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, Texas; Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana; Ejura-Sekyedumase District Hospital, Ejura, Ghana.
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Elmore
authors.affiliation: College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, Texas; Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana; Ejura-Sekyedumase District Hospital, Ejura, Ghana.
authors.forename: Kristal A
authors.initials: KA
authors.lastname: Rychlik
authors.affiliation: College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, Texas; Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana; Ejura-Sekyedumase District Hospital, Ejura, Ghana.
authors.forename: Katherine E
authors.initials: KE
authors.lastname: Zychowski
authors.affiliation: College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, Texas; Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana; Ejura-Sekyedumase District Hospital, Ejura, Ghana.
authors.forename: Amelia A
authors.initials: AA
authors.lastname: Romoser
authors.affiliation: College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, Texas; Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana; Ejura-Sekyedumase District Hospital, Ejura, Ghana.
authors.forename: Timothy D
authors.initials: TD
authors.lastname: Phillips
authors.affiliation: College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, Texas; Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana; Ejura-Sekyedumase District Hospital, Ejura, Ghana NAnkrah@noguchi.ug.edu.gh.
authors.forename: Nii-Ayi
authors.initials: NA
authors.lastname: Ankrah
mesh_terms: D000348:Aflatoxins / Q000009:adverse effects* / Q000652:urine; D000538:Aluminum Silicates; D001546:Bentonite / Q000008:administration & dosage* / Q000009:adverse effects; D002118:Calcium / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D000077215:Clay; D004311:Double-Blind Method; D004781:Environmental Exposure; D005260:Female; D005506:Food Contamination / Q000517:prevention & control*; D059022:Food Safety; D005869:Ghana; D006801:Humans; D008297:Male; D008903:Minerals / Q000097:blood; D016896:Treatment Outcome
chemical_list: D000348:Aflatoxins; D000538:Aluminum Silicates; D008903:Minerals; D001546:Bentonite; D002118:Calcium; D000077215:Clay