Registration Dossier
Registration Dossier
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EC number: 274-324-8 | CAS number: 70131-50-9
Endpoint summary
Administrative data
Description of key information
A clinical trial performed with NovaSil clay (naturally occurring calcium montmorillonite) demonstrated that administration of NS capsules ( 1.5 and 3.0 g day) over a 3 month period was apparently safe, as evidenced by physical examinations, hematological and biochemical parameters (Afriyie-Gyaeu et al 2008).
Additional information
A 3 month double blind double blind and placebo controlled, phase IIa clinical trial was conducted in Ghana to investigate the dafety, 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 per day.Physical examinations were performed monthly. Blood and urine samples were collected for laboratory analysis. No significant differences were shown in hematology, liver and kidney function or electrolytes in the three groups. The findings demonstrated that NS clay is apparently safe and practical for the protection of humans against aflatoxines in populations at high risk for aflatoxicosis.
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