A double-blinded, placebo controlled clinical trial was conducted to investigate the safety and tolerance of dietary NovaSil (NS) in human populations in Ghana over a period of three-months. Volunteers (507 subjects, ages from 18 – 58 yrs) were clinically screened to evaluate their general health, pregnancy status, and levels of blood AFB1-Albumin adducts. Of these subjects, 177 (101 males, 76 females) were randomly assigned to 3 groups: high-dose (HD), low-dose (LD) and placebo-contro (PL) groups receiving 3.0, 1.5 and 0 g NS/day in capsules. These were administeredto each participant under the supervision of trained study monitors prior to meals. Blood and urine samples were collected for laboratory analysis. Physical examinations were performed monthly and follow-up was taken to record any side effects daily. Ninety-four percent of the participants (166 of 177) completed the study and compliance rate was 97.4%, 96.4%, and 98.5% for HD, LD, and PL, respectively. Mild to moderate side effects were recorded in some participants. Throughout the study duration, the total reported side effects with respect to possible complaints were 0.66%, 0.68%, and 0.48% for HD, LD, and PL, respectively. Symptoms included nausea, vomiting, diarrhea, flatulence, abdominal discomfort, heartburn and dizziness. These side effects were neither dose-dependent nor statistically significant among the three groups. Also, some participants (in all groups) reported having increased appetite in the course of the study. Overall, 99.4% of person time during the study reported no side effects. No significant differences were shown in hematology, liver and kidney function, electrolytes, and vital signs in the three groups. These findings demonstrate that NS clay for the protection of humans at high risk for aflatoxicosis is practical and economically feasible. (Supported by USAID LAG-G-00-96-90013-00).
- Novasil clay,
Available at: http://works.bepress.com/evans_afriyie-gyawu/44/