<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02188953</url>
  </required_header>
  <id_info>
    <org_study_id>SSC Protocol No. 2603</org_study_id>
    <nct_id>NCT02188953</nct_id>
  </id_info>
  <brief_title>Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya</brief_title>
  <acronym>ACCS100</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kenya Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Texas A&amp;M University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kenya Ministry of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kenya Medical Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to pilot test the effectiveness, acceptability, and palatability&#xD;
      of ACCS100 in a high-risk Kenyan population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aflatoxins are harmful by-products of the molds Aspergillus flavus and A. parasiticus and are&#xD;
      major contaminants of agricultural produce such as maize. Acute aflatoxin exposure (i.e.,&#xD;
      aflatoxicosis) can lead to jaundice, vomiting, abdominal pain, and liver failure, with&#xD;
      documented fatality rates as high as 40%. Kenya experiences extreme aflatoxin exposure and&#xD;
      fatal, recurring aflatoxicosis outbreaks. Numerous clinical trials have found heat processed&#xD;
      calcium dioctahedral smectite clay [i.e., Air Classified Calcium Silicate (ACCS100)] to be&#xD;
      safe and effective in binding to aflatoxin to decrease bioavailability and subsequently&#xD;
      reduce toxin-induced effects. The investigators propose to pilot test the effectiveness,&#xD;
      acceptability, and palatability of ACCS100 in a high-risk Kenyan population. If successful,&#xD;
      ACCS100 could be scaled-up for use in Kenya to prevent aflatoxin-associated mortality during&#xD;
      high-risk periods. To accomplish this objective, the investigators will recruit fifty health&#xD;
      adults into a crossover study. Each participant will spend one week consuming ACCS100 and one&#xD;
      week consuming a calcium carbonate placebo. Daily first morning void urine samples will&#xD;
      monitor effectiveness in reducing aflatoxin bioavailability, and periodic questionnaires will&#xD;
      assess acceptance and palatability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of urine aflatoxin M1 levels</measure>
    <time_frame>Daily during each study arm</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum aflatoxin B1-lysine adduct levels</measure>
    <time_frame>Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20)</time_frame>
    <description>Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palatability questionnaire</measure>
    <time_frame>End of arm 1 (Day 8) and end of arm 2 (Day 20)</time_frame>
    <description>End of arm 1 (Day 8) and end of arm 2 (Day 20)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily diary and adverse event reporting form</measure>
    <time_frame>Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20)</time_frame>
    <description>Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability questionnaire</measure>
    <time_frame>End of arm 2 (Day 20)</time_frame>
    <description>End of arm 2 (Day 20)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Aflatoxicosis</condition>
  <arm_group>
    <arm_group_label>ACCS100</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calcium carbonate</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACCS100</intervention_name>
    <description>ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate, which is a substance generally recognized as safe by the U.S. FDA.</description>
    <arm_group_label>ACCS100</arm_group_label>
    <other_name>Air Classified Calcium Silicate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium carbonate placebo</intervention_name>
    <arm_group_label>Calcium carbonate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult ≥18 years of age&#xD;
&#xD;
          -  Consumes corn- and/or peanut-derived foods at least four times per week&#xD;
&#xD;
          -  No plans to travel away from the household for more than one day in the next month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who may be pregnant&#xD;
&#xD;
          -  History of medical illnesses&#xD;
&#xD;
          -  Presence of protein or glucose in urine using chemstrip&#xD;
&#xD;
          -  Does not provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Vulule, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kenya Medical Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ellen Yard, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>U.S. Centers for Disease Control and Prevention</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Johnni Daniel, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>U.S. Centers for Disease Control and Prevention</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Timothy Philips, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas A&amp;M University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samuel Amwayi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kenya Ministry of Public Health and Sanitation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Makindu Health Center</name>
      <address>
        <city>Makindu</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>18478481</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18286403</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18569006</PMID>
  </reference>
  <reference>
    <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. doi: 10.1080/02652030500111129.</citation>
    <PMID>16019795</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16019794</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kenya Medical Research Institute</investigator_affiliation>
    <investigator_full_name>Dr. John Vulule</investigator_full_name>
    <investigator_title>Director, Center for Global Health Research</investigator_title>
  </responsible_party>
  <keyword>aflatoxin</keyword>
  <keyword>Kenya</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Calcium Carbonate</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02188953
org study id: SSC Protocol No. 2603
nct id: NCT02188953
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to pilot test the effectiveness, acceptability, and palatability
      of ACCS100 in a high-risk Kenyan population.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline of urine aflatoxin M1 levels
time frame: Daily during each study arm
description: 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).
measure: Serum aflatoxin B1-lysine adduct levels
time frame: Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20)
description: Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20).
measure: Palatability questionnaire
time frame: End of arm 1 (Day 8) and end of arm 2 (Day 20)
description: End of arm 1 (Day 8) and end of arm 2 (Day 20)
measure: Daily diary and adverse event reporting form
time frame: Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20)
description: Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20)
measure: Acceptability questionnaire
time frame: End of arm 2 (Day 20)
description: End of arm 2 (Day 20)
arm group label: ACCS100
arm group type: Experimental
description: 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.
arm group label: Calcium carbonate
arm group type: Placebo Comparator
description: 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 type: Drug
intervention name: ACCS100
description: ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate, which is a substance generally recognized as safe by the U.S. FDA.
arm group label: ACCS100
other name: Air Classified Calcium Silicate
intervention type: Drug
intervention name: Calcium carbonate placebo
arm group label: Calcium carbonate
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: John Vulule, PhD
role: Principal Investigator
affiliation: Kenya Medical Research Institute
last name: Ellen Yard, PhD
role: Principal Investigator
affiliation: U.S. Centers for Disease Control and Prevention
last name: Johnni Daniel, MPH
role: Principal Investigator
affiliation: U.S. Centers for Disease Control and Prevention
last name: Timothy Philips, PhD
role: Principal Investigator
affiliation: Texas A&M University
last name: Samuel Amwayi, MD
role: Principal Investigator
affiliation: Kenya Ministry of Public Health and Sanitation
facility: 
country: Kenya
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.
PMID: 18478481
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.
PMID: 18286403
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.
PMID: 18569006
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. doi: 10.1080/02652030500111129.
PMID: 16019795
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Kenya Medical Research Institute
investigator full name: Dr. John Vulule
investigator title: Director, Center for Global Health Research
mesh term: Calcium, Dietary
mesh term: Calcium Carbonate
mesh term: Calcium