Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya

NCT02188953 | Completed Phase 2

• 1 other identifier: SSC Protocol No. 2603
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aflatoxicosis

Keywords

aflatoxin; Kenya

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Serum aflatoxin B1-lysine adduct levels

  Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20)

• Palatability questionnaire

  End of arm 1 (Day 8) and end of arm 2 (Day 20)

• Daily diary and adverse event reporting form

  Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20)

• Acceptability questionnaire

  End of arm 2 (Day 20)

Study Arms (2)

ACCS100

EXPERIMENTAL

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

Calcium carbonate

PLACEBO COMPARATOR

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

Interventions

ACCS100 DRUG

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

Also known as: Air Classified Calcium Silicate

ACCS100

Calcium carbonate placebo DRUG

Calcium carbonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women who may be pregnant
• History of medical illnesses
• Presence of protein or glucose in urine using chemstrip
• Does not provide informed consent

Sponsors & Collaborators

• Kenya Medical Research Institute: lead
• Centers for Disease Control and Prevention: collaborator
• Texas A&M University: collaborator
• Kenya Ministry of Health: collaborator

Study Sites (1)

Makindu Health Center

Makindu, Kenya

Location

Related Publications (5)

• 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.

  PMID: 18478481 BACKGROUND

• 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.

  PMID: 18286403 BACKGROUND

• 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.

  PMID: 18569006 BACKGROUND

• 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.

  PMID: 16019795 BACKGROUND

• 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.

  PMID: 16019794 BACKGROUND

Related Links

• Description of ACCS100 clay

MeSH Terms

Conditions

Aflatoxin Poisoning

Interventions

ACCS100

Condition Hierarchy (Ancestors)

Mycotoxicosis; Poisoning; Chemically-Induced Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Global Health Research

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 14, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

KE (1)