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

September 15, 2014 updated by: Dr. John Vulule, Kenya Medical Research Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Makindu, Kenya
        • Makindu Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Daily during each study arm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20)
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)
End of arm 1 (Day 8) and end of arm 2 (Day 20)
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)
Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20)
Acceptability questionnaire
Time Frame: End of arm 2 (Day 20)
End of arm 2 (Day 20)
End of arm 2 (Day 20)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kenya Medical Research Institute

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Estimate)

September 16, 2014

Last Update Submitted That Met QC Criteria

September 15, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSC Protocol No. 2603

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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