Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya (ACCS100)

• ClinicalTrials.gov Identifier: NCT02188953
• Recruitment Status: Completed
• First Posted: July 14, 2014
• Last Update Posted: September 16, 2014
• Sponsor: Kenya Medical Research Institute
• Collaborators: Centers for Disease Control and Prevention; Texas A&M University; Kenya Ministry of Health
• Information provided by (Responsible Party): Dr. John Vulule, Kenya Medical Research Institute

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Aflatoxicosis	Drug: ACCS100; Drug: Calcium carbonate placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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 Start Date: August 2014
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: September 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: ACCS100; 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; ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate, which is a substance generally recognized as safe by the U.S. FDA.; Other Name: Air Classified Calcium Silicate
Placebo Comparator: Calcium carbonate; 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

Outcome Measures

Primary Outcome Measures :

1. Change from baseline of urine aflatoxin M1 levels [ Time Frame: Daily during each study arm ]
   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).

Secondary Outcome Measures :

1. Serum aflatoxin B1-lysine adduct levels [ Time Frame: 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).
2. Palatability questionnaire [ Time Frame: 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)
3. Daily diary and adverse event reporting form [ Time Frame: 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)
4. Acceptability questionnaire [ Time Frame: End of arm 2 (Day 20) ]
   End of arm 2 (Day 20)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Kenya

Makindu Health Center

Makindu, Kenya

Sponsors and Collaborators

Kenya Medical Research Institute

Centers for Disease Control and Prevention

Texas A&M University

Kenya Ministry of Health

Investigators

• Principal Investigator: John Vulule, PhD; Kenya Medical Research Institute
• Principal Investigator: Ellen Yard, PhD; U.S. Centers for Disease Control and Prevention
• Principal Investigator: Johnni Daniel, MPH; U.S. 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

More Information

Additional Information:

Description of ACCS100 clay 

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.

• Responsible Party: Dr. John Vulule, Director, Center for Global Health Research, Kenya Medical Research Institute
• ClinicalTrials.gov Identifier: NCT02188953
• Other Study ID Numbers: SSC Protocol No. 2603
• First Posted: July 14, 2014
• Last Update Posted: September 16, 2014
• Last Verified: September 2014

Keywords provided by Dr. John Vulule, Kenya Medical Research Institute:

aflatoxin; Kenya

Additional relevant MeSH terms:

Calcium, Dietary; Calcium Carbonate; Calcium; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Antacids; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents