Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya

Aflatoxicosis Clinical Trial

— ACCS100  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188953
• Other study ID #: SSC Protocol No. 2603
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2014
• Last updated: September 15, 2014
• Start date: August 2014
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Kenya Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review CommitteeKenya: Pharmacy and Poisons BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aflatoxicosis

Intervention

Drug:
• ACCS100
ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate, which is a substance generally recognized as safe by the U.S. FDA.
• Calcium carbonate placebo

Locations

Country	Name	City	State
Kenya	Makindu Health Center	Makindu

Sponsors (4)

Lead Sponsor	Collaborator
Kenya Medical Research Institute	Centers for Disease Control and Prevention, Kenya Ministry of Health, Texas A&M University

Country where clinical trial is conducted

Kenya, 

References & Publications (5)

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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	Palatability questionnaire	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)	No
Secondary	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)	No
Secondary	Acceptability questionnaire	End of arm 2 (Day 20)	End of arm 2 (Day 20)	No

External Links

•   Description of ACCS100 clay