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

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ClinicalTrials.gov Identifier: NCT02188953
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : September 16, 2014
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE July 2, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date September 16, 2014
Study Start Date  ICMJE August 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
  • 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).
  • 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)
  • 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)
  • Acceptability questionnaire [ Time Frame: End of arm 2 (Day 20) ]
    End of arm 2 (Day 20)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya
Official Title  ICMJE 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
Brief Summary The purpose of this study is to pilot test the effectiveness, acceptability, and palatability of ACCS100 in a high-risk Kenyan population.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Aflatoxicosis
Intervention  ICMJE
  • 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
  • Drug: Calcium carbonate placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: ACCS100
  • 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.
    Intervention: Drug: Calcium carbonate placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188953
Other Study ID Numbers  ICMJE SSC Protocol No. 2603
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. John Vulule, Kenya Medical Research Institute
Study Sponsor  ICMJE Kenya Medical Research Institute
Collaborators  ICMJE
  • Centers for Disease Control and Prevention
  • Texas A&M University
  • Kenya Ministry of Health
Investigators  ICMJE
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
PRS Account Kenya Medical Research Institute
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP