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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 levels

Palatability 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

Page last updated: August 20, 2015

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