Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
| Imethibitishwa Mwisho: | 08/31/2014 |
| Iliyowasilishwa Kwanza: | 07/01/2014 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 07/10/2014 |
| Iliyotumwa Kwanza: | 07/13/2014 |
| Sasisho la Mwisho Liliwasilishwa: | 09/14/2014 |
| Sasisho la Mwisho Lilichapishwa: | 09/15/2014 |
| Tarehe halisi ya kuanza kwa masomo: | 07/31/2014 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 08/31/2014 |
| Tarehe ya Kukamilisha Utafiti: | 08/31/2014 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: ACCS100
Drug: Calcium carbonate
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: 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. | Drug: ACCS100 ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate, which is a substance generally recognized as safe by the U.S. FDA. |
| 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 |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | 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 |
Matokeo
Hatua za Matokeo ya Msingi
1. Change from baseline of urine aflatoxin M1 levels [Daily during each study arm]
Hatua za Matokeo ya Sekondari
1. Serum aflatoxin B1-lysine adduct levels [Baseline of Arm 1 (Day 0) and end of arm 2 (Day 20)]
2. Palatability questionnaire [End of arm 1 (Day 8) and end of arm 2 (Day 20)]
3. Daily diary and adverse event reporting form [Daily during arm 1 (Days 2-8) and arm 2 (Days 14-20)]
4. Acceptability questionnaire [End of arm 2 (Day 20)]
