Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya

Study Overview
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Brief Summary
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The purpose of this study is to pilot test the effectiveness, acceptability, and palatability of ACCS100 in a high-risk Kenyan population.

Detailed Description
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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.

Official Title
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Evaluation of the Effectiveness, Acceptability, and Palatability of Air Classified Calcium Silicate (ACCS100) Clay to Reduce Aflatoxin Exposure in a High-risk Community in Kenya

Conditions
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Aflatoxicosis

Intervention / Treatment
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* Drug: ACCS100
* Drug: Calcium carbonate placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACCS100<br>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<br>* ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate, which is a substance generally recognized as safe by the U.S. FDA.<br>* Other names: Air Classified Calcium Silicate;|
| Placebo Comparator: Calcium carbonate<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Daily during each study arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aflatoxin, Kenya