Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya

Kenya Medical Research Institute50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Aflatoxicosis

Interventions

ACCS100DRUG

ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate, which is a substance generally recognized as safe by the U.S. FDA.

Calcium carbonate placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Makindu Health Center

Makindu, Kenya

Outcomes

Primary Outcomes

Change from baseline of urine aflatoxin M1 levels

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).

Time frame: Daily during each study arm

Secondary Outcomes

Serum aflatoxin B1-lysine adduct levels

Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20).

Time frame: 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)

Time frame: End of arm 1 (Day 8) and end of arm 2 (Day 20)

Daily diary and adverse event reporting form

Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20)

Time frame: Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20)

Acceptability questionnaire

End of arm 2 (Day 20)

Time frame: End of arm 2 (Day 20)

Data from ClinicalTrials.gov

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