Clinical trial NCT02188953: Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aflatoxicosis
Keywords: aflatoxin
Kenya
Lead sponsor: Kenya Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Texas A&M University
name: Kenya Ministry of Health
First posted: 2014-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of urine aflatoxin M1 levels
timeFrame: Daily during each study arm
Secondary outcomes:
measure: Serum aflatoxin B1-lysine adduct levels
timeFrame: Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20)
measure: Palatability questionnaire
timeFrame: End of arm 1 (Day 8) and end of arm 2 (Day 20)
measure: Daily diary and adverse event reporting form
timeFrame: Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20)
measure: Acceptability questionnaire
timeFrame: End of arm 2 (Day 20)
Other outcomes:
Locations:
city: Makindu
country: Kenya
facility: Makindu Health Center
Study officials:
affiliation: Kenya Medical Research Institute
name: John Vulule, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: U.S. Centers for Disease Control and Prevention
name: Ellen Yard, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: U.S. Centers for Disease Control and Prevention
name: Johnni Daniel, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas A&M University
name: Timothy Philips, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenya Ministry of Public Health and Sanitation
name: Samuel Amwayi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.