Evaluation of the efficacy, acceptability and palatability of calcium montmorillonite clay used to reduce aflatoxin B1 dietary exposure in a crossover study in Kenya.
Acute aflatoxin exposure can cause death and disease (aflatoxicosis) in humans. Aflatoxicosis fatality rates have been documented to be as high as 40% in Kenya. The inclusion in the diet of calcium silicate 100 (ACCS100), a calcium montmorillonite clay, may reduce aflatoxin bioavailability, thus potentially decreasing the risk of aflatoxicosis. We investigated the efficacy, acceptability and palatability of ACCS100 in a population in Kenya with recurring aflatoxicosis outbreaks. Healthy adult participants were enrolled in this double-blinded, crossover clinical trial in 2014. Following informed consent, participants (n = 50) were randomised to receive either ACCS100 (3 g day-1) or placebo (3 g day-1) for 7 days. Treatments were switched following a 5-day washout period. Urine samples were collected daily and assessed for urinary aflatoxin M1 (AFM1). Blood samples were collected at the beginning and end of the trial and assessed for aflatoxin B1-lysine adducts from serum albumin (AFB1-lys). AFM1concentrations in urine were significantly reduced while taking ACCS100 compared with calcium carbonate placebo (β = 0.49, 95% confidence limit = 0.32-0.75). The 20-day interval included both the placebo and ACCS100 treatments as well as a washout period. There were no statistically significant differences in reported taste, aftertaste, appearance, colour or texture by treatment. There were no statistically significant differences in self-reported adverse events by treatment. Most participants would be willing to take ACCS100 (98%) and give it to their children (98%). ACCS100 was effective, acceptable and palatable. More work is needed to test ACCS100 among vulnerable populations and to determine if it remains effective at the levels of aflatoxin exposure that induce aflatoxicosis.
a US Centers for Disease Control and Prevention (CDC), Kenya , Center for Global Health , Nairobi , Kenya.
Abigael O
AO
Awuor
b US Centers for Disease Control and Prevention (CDC) , National Center for Environmental Health , Atlanta , GA , USA.
Ellen
E
Yard
b US Centers for Disease Control and Prevention (CDC) , National Center for Environmental Health , Atlanta , GA , USA.
Johnni H
JH
Daniel
b US Centers for Disease Control and Prevention (CDC) , National Center for Environmental Health , Atlanta , GA , USA.
Collen
C
Martin
c Centre for Microbiology Research Nairobi , Kenya Medical Research Institute , Kisumu , Kenya.
Christine
C
Bii
d College of Veterinary Medicine and Biomedical Sciences , Texas A&M University , College Station , TX , USA.
Amelia
A
Romoser
e Ministry of Health , Field Epidemiology and Laboratory Training Program , Nairobi , Kenya.
Elvis
E
Oyugi
d College of Veterinary Medicine and Biomedical Sciences , Texas A&M University , College Station , TX , USA.
Sarah
S
Elmore
e Ministry of Health , Field Epidemiology and Laboratory Training Program , Nairobi , Kenya.
Samwel
S
Amwayi
f Centre for Public Health Research , Kenya Medical Research Institute , Kisumu , Kenya.
John
J
Vulule
b US Centers for Disease Control and Prevention (CDC) , National Center for Environmental Health , Atlanta , GA , USA.
Nicholas C
NC
Zitomer
b US Centers for Disease Control and Prevention (CDC) , National Center for Environmental Health , Atlanta , GA , USA.
Michael E
ME
Rybak
d College of Veterinary Medicine and Biomedical Sciences , Texas A&M University , College Station , TX , USA.
Timothy D
TD
Phillips
a US Centers for Disease Control and Prevention (CDC), Kenya , Center for Global Health , Nairobi , Kenya.
Joel M
JM
Montgomery
b US Centers for Disease Control and Prevention (CDC) , National Center for Environmental Health , Atlanta , GA , USA.
Lauren S
LS
Lewis
D016604:Aflatoxin B1 / Q000633:toxicity*; D001546:Bentonite / Q000009:adverse effects / Q000737:chemistry*; D018592:Cross-Over Studies; D004032:Diet; D004781:Environmental Exposure; D005260:Female; D006801:Humans; D007630:Kenya; D008297:Male
D001546:Bentonite; D016604:Aflatoxin B1
ACCS100; Kenya; Novasil; aflatoxicosis; aflatoxin; calcium montmorillonite; clay; uniform particle size Novasil (UPSN)