A Phase 2 interventional study of ACCS100 and Calcium carbonate placebo in Aflatoxicosis, sponsored by Kenya Medical Research Institute. Completed at 1 site in Kenya. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-16.
Sponsored by Kenya Medical Research Institute · Phase 2, Interventional, and Prevention
The purpose of this study is to pilot test the effectiveness, acceptability, and palatability of ACCS100 in a high-risk Kenyan population.
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.
Kenya Medical Research Institute is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will consume 1 gram of ACCS100 at each meal (up to three times per day) for seven days. The ACCS100 will be administered by mixing a powder sachet into water.
Drug: ACCS100
Participants will consume 1 gram of calcium carbonate at each meal (up to three times per day) for seven days. The calcium carbonate will be administered by mixing a powder sachet into water.
Drug: Calcium carbonate placebo
ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate, which is a substance generally recognized as safe by the U.S. FDA.
Also known as: Air Classified Calcium Silicate
Change from baseline of urine aflatoxin M1 levels
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).
Time frame: Daily during each study arm
Serum aflatoxin B1-lysine adduct levels
Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20).
Time frame: 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)
Time frame: 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)
Time frame: Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20)
Acceptability questionnaire
End of arm 2 (Day 20)
Time frame: End of arm 2 (Day 20)
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Aflatoxin Poisoning
Kenya Medical Research Institute