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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Texas A&M University | OTHER |
| Kenya Ministry of Health | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACCS100 | Experimental | 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. |
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| Calcium carbonate | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACCS100 | Drug | ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate, which is a substance generally recognized as safe by the U.S. FDA. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Vulule, PhD | Kenya Medical Research Institute | Principal Investigator |
| Ellen Yard, PhD | Centers for Disease Control and Prevention | Principal Investigator |
| Johnni Daniel, MPH | Centers for Disease Control and Prevention | Principal Investigator |
| Timothy Philips, PhD | Texas A&M University | Principal Investigator |
| Samuel Amwayi, MD | Kenya Ministry of Public Health and Sanitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makindu Health Center | Makindu | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18478481 | Background | Wang P, Afriyie-Gyawu E, Tang Y, Johnson NM, Xu L, Tang L, Huebner HJ, Ankrah NA, Ofori-Adjei D, Ellis W, Jolly PE, Williams JH, Wang JS, Phillips TD. NovaSil clay intervention in Ghanaians at high risk for aflatoxicosis: II. Reduction in biomarkers of aflatoxin exposure in blood and urine. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2008 May;25(5):622-34. doi: 10.1080/02652030701598694. | |
| 18286403 |
| Label | URL |
|---|---|
| Description of ACCS100 clay | View source |
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| ID | Term |
|---|---|
| D000096702 | Aflatoxin Poisoning |
| ID | Term |
|---|---|
| D015651 | Mycotoxicosis |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C000615779 | ACCS100 |
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| Calcium carbonate placebo | Drug |
|
| 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) |
| Background |
| Phillips TD, Afriyie-Gyawu E, Williams J, Huebner H, Ankrah NA, Ofori-Adjei D, Jolly P, Johnson N, Taylor J, Marroquin-Cardona A, Xu L, Tang L, Wang JS. Reducing human exposure to aflatoxin through the use of clay: a review. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2008 Feb;25(2):134-45. doi: 10.1080/02652030701567467. |
| 18569006 | Background | Afriyie-Gyawu E, Wang Z, Ankrah NA, Xu L, Johnson NM, Tang L, Guan H, Huebner HJ, Jolly PE, Ellis WO, Taylor R, Brattin B, Ofori-Adjei D, Williams JH, Wang JS, Phillips TD. NovaSil clay does not affect the concentrations of vitamins A and E and nutrient minerals in serum samples from Ghanaians at high risk for aflatoxicosis. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2008 Jul;25(7):872-84. doi: 10.1080/02652030701854758. |
| 16019795 | Background | Wang JS, Luo H, Billam M, Wang Z, Guan H, Tang L, Goldston T, Afriyie-Gyawu E, Lovett C, Griswold J, Brattin B, Taylor RJ, Huebner HJ, Phillips TD. Short-term safety evaluation of processed calcium montmorillonite clay (NovaSil) in humans. Food Addit Contam. 2005 Mar;22(3):270-9. doi: 10.1080/02652030500111129. |
| 16019794 | Background | Afriyie-Gyawu E, Mackie J, Dash B, Wiles M, Taylor J, Huebner H, Tang L, Guan H, Wang JS, Phillips T. Chronic toxicological evaluation of dietary NovaSil clay in Sprague-Dawley rats. Food Addit Contam. 2005 Mar;22(3):259-69. doi: 10.1080/02652030500110758. |