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|Title: ||NovaSil clay intervention in Ghanaians at high risk for aflatoxicosis. I. Study design and clinical outcomes|
|Authors: ||Phillips, T. D.|
Williams, J. H.
Ellis, William Otoo
Jolly, P. E.
Johnson, N. M.
Huebner, H. J.
|Keywords: ||clinical outcomes|
|Issue Date: ||29-Nov-2007|
|Publisher: ||Food Additives & Contaminants|
|Citation: ||Food Additives & Contaminants:ISSN: 1944-0049 (Print) 1944-0057|
|Abstract: ||A 3-month double-blind and placebo-controlled, phase IIa clinical trial was conducted in Ghana to investigate the safety,
tolerance and aflatoxin-sorption efficacy of dietary NovaSil (NS). Volunteers (507 subjects) were clinically screened to
evaluate their general health, pregnancy status and blood AFB1–albumin adduct levels. Of these subjects, 177 were
randomly assigned to three groups: high-dose (HD), low-dose (LD) and placebo-control (PL) groups receiving 3.0, 1.5 and
0 g NS day 1 in capsules. Trained study-monitors supervised NS capsule administration to participants and recorded sideeffects
daily. Physical examinations were performed monthly. Blood and urine samples were collected for laboratory
analysis. Approximately 92% of the participants (162 of 177) completed the study and compliance rate was over 97%.
Overall, 99.5% of person time reported no side-effects throughout the study. Mild to moderate health events ( 0.5% of
person time) were recorded in some participants. Symptoms included nausea, diarrhea, heartburn and dizziness. These
side-effects were statistically similar among all three groups. No significant differences were shown in hematology, liver and
kidney function or electrolytes in the three groups. These findings demonstrate that NS clay is apparently safe and practical
for the protection of humans against aflatoxins in populations at high risk for aflatoxicosis.|
|Description: ||This Article was published by Food Additives & Contaminants:ISSN: 1944-0049 (Print) 1944-0057|
|Appears in Collections:||College of Science|
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