Aflatoxicosis
Conditions
Keywords
aflatoxin, Kenya
Brief summary
The purpose of this study is to pilot test the effectiveness, acceptability, and palatability of ACCS100 in a high-risk Kenyan population.
Detailed description
Aflatoxins are harmful by-products of the molds Aspergillus flavus and A. parasiticus and are major contaminants of agricultural produce such as maize. Acute aflatoxin exposure (i.e., aflatoxicosis) can lead to jaundice, vomiting, abdominal pain, and liver failure, with documented fatality rates as high as 40%. Kenya experiences extreme aflatoxin exposure and fatal, recurring aflatoxicosis outbreaks. Numerous clinical trials have found heat processed calcium dioctahedral smectite clay \[i.e., Air Classified Calcium Silicate (ACCS100)\] to be safe and effective in binding to aflatoxin to decrease bioavailability and subsequently reduce toxin-induced effects. The investigators propose to pilot test the effectiveness, acceptability, and palatability of ACCS100 in a high-risk Kenyan population. If successful, ACCS100 could be scaled-up for use in Kenya to prevent aflatoxin-associated mortality during high-risk periods. To accomplish this objective, the investigators will recruit fifty health adults into a crossover study. Each participant will spend one week consuming ACCS100 and one week consuming a calcium carbonate placebo. Daily first morning void urine samples will monitor effectiveness in reducing aflatoxin bioavailability, and periodic questionnaires will assess acceptance and palatability.
Interventions
DRUGACCS100
ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate, which is a substance generally recognized as safe by the U.S. FDA.
DRUGCalcium carbonate placebo
Sponsors
Centers for Disease Control and Prevention
Texas A&M University
Kenya Ministry of Health
Kenya Medical Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult ≥18 years of age * Consumes corn- and/or peanut-derived foods at least four times per week * No plans to travel away from the household for more than one day in the next month
Exclusion criteria
* Women who may be pregnant * History of medical illnesses * Presence of protein or glucose in urine using chemstrip * Does not provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of urine aflatoxin M1 levels | Daily during each study arm | Urine samples will be collected at baseline (Day 0) and daily for seven days during Arm 1 (Days 1-7). Urine samples will also be collected at baseline (Day 13) and daily for seven days during Arm 2 (Days 13-19). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum aflatoxin B1-lysine adduct levels | Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20) | Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20). |
| Palatability questionnaire | End of arm 1 (Day 8) and end of arm 2 (Day 20) | End of arm 1 (Day 8) and end of arm 2 (Day 20) |
| Daily diary and adverse event reporting form | Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20) | Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20) |
| Acceptability questionnaire | End of arm 2 (Day 20) | End of arm 2 (Day 20) |
Countries
Kenya
Outcome results
None listed