Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya

Kenya Medical Research Institute (KEMRI)

Status and phase: Completed; Phase 2

Conditions: Aflatoxicosis

Treatments: Drug: ACCS100; Drug: Calcium carbonate placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02188953

SSC Protocol No. 2603

Details and patient eligibility

About

The purpose of this study is to pilot test the effectiveness, acceptability, and palatability of ACCS100 in a high-risk Kenyan population.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

ACCS100

Experimental group

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.

Treatment:

Drug: ACCS100

Calcium carbonate

Placebo Comparator group

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.

Treatment:

Drug: Calcium carbonate placebo