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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline of urine aflatoxin M1 levels
研究概览
简要总结
The purpose of this study is to pilot test the effectiveness, acceptability, and palatability of ACCS100 in a high-risk Kenyan population.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Women who may be pregnant
- •History of medical illnesses
- •Presence of protein or glucose in urine using chemstrip
- •Does not provide informed consent
研究组 & 干预措施
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.
干预措施: ACCS100 (Drug)
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.
干预措施: Calcium carbonate placebo (Drug)
结局指标
主要结局
Change from baseline of urine aflatoxin M1 levels
时间窗: 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).
次要结局
- Daily diary and adverse event reporting form(Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20))
- Serum aflatoxin B1-lysine adduct levels(Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20))
- Palatability questionnaire(End of arm 1 (Day 8) and end of arm 2 (Day 20))
- Acceptability questionnaire(End of arm 2 (Day 20))
研究者
Dr. John Vulule
Director, Center for Global Health Research
Kenya Medical Research Institute