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
|Condition or disease||Intervention/treatment||Phase|
|Aflatoxicosis||Drug: ACCS100 Drug: Calcium carbonate placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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
- 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).
- 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)
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
|Makindu Health Center|
|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|