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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02188953 |
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Date of registration:
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02/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya
ACCS100 |
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Scientific title:
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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 |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02188953 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 2
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Johnni Daniel, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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U.S. Centers for Disease Control and Prevention |
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Name:
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John Vulule, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kenya Medical Research Institute |
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Name:
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Samuel Amwayi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kenya Ministry of Public Health and Sanitation |
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Name:
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Timothy Philips, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Texas A&M University |
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Name:
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Ellen Yard, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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U.S. Centers for Disease Control and Prevention |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aflatoxicosis
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Intervention(s)
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Drug: Calcium carbonate placebo
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Drug: ACCS100
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Primary Outcome(s)
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Change from baseline of urine aflatoxin M1 levels
[Time Frame: Daily during each study arm]
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Secondary Outcome(s)
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Acceptability questionnaire
[Time Frame: End of arm 2 (Day 20)]
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Serum aflatoxin B1-lysine adduct levels
[Time Frame: Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20)]
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Palatability questionnaire
[Time Frame: End of arm 1 (Day 8) and end of arm 2 (Day 20)]
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Daily diary and adverse event reporting form
[Time Frame: Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20)]
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Secondary ID(s)
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SSC Protocol No. 2603
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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