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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

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



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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188953


Locations
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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
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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
Additional Information:
Publications:

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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    Key Record Dates
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:
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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