Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya
Information source: Kenya Medical Research Institute
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aflatoxicosis
Intervention: ACCS100 (Drug); Calcium carbonate placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Kenya Medical Research Institute Official(s) and/or principal investigator(s): John Vulule, PhD, Principal Investigator, Affiliation: Kenya Medical Research Institute Ellen Yard, PhD, Principal Investigator, Affiliation: U.S. Centers for Disease Control and Prevention Johnni Daniel, MPH, Principal Investigator, Affiliation: U.S. Centers for Disease Control and Prevention Timothy Philips, PhD, Principal Investigator, Affiliation: Texas A&M University Samuel Amwayi, MD, Principal Investigator, Affiliation: Kenya Ministry of Public Health and Sanitation
Summary
The purpose of this study is to pilot test the effectiveness, acceptability, and
palatability of ACCS100 in a high-risk Kenyan population.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Change from baseline of urine aflatoxin M1 levels
Secondary outcome: Serum aflatoxin B1-lysine adduct levelsPalatability questionnaire Daily diary and adverse event reporting form Acceptability questionnaire
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Makindu Health Center, Makindu, Kenya
Additional Information
Description of ACCS100 clay
Related publications: 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. 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. Review. 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. 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. 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.
Starting date: August 2014
Last updated: September 15, 2014
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