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Presentation
Three-Month Clinical Intervention Trial with NovaSil Clay in Ghanaians: No Influence on Utilization Vitamins A and E
Society of Toxicology Annual (46th) Meeting (2007)
  • Z. Wang, Texas Tech University
  • Li Xu, Texas Tech University
  • Hongxia Guan, Texas Tech University
  • X. He, Texas Tech University
  • Lili Tang, Texas Tech University
  • Evans Afriyie-Gyawu, Georgia Southern University
  • Henry J. Huebner, Texas A & M University - College Station
  • Nii-Ayi Ankrah, University of Ghana
  • D. Ofori-Adjei, University of Ghana
  • Jonathon H. Williams, University of Georgia
  • Jia-Sheng Wang, Texas Tech University
  • Timothy D. Phillips
Abstract

Dietary exposure to aflatoxins (AF) decreases serum and tissue vitamins (Vit) A and E levels in addition to causing liver damage. NovaSil clay (NS) provides significant protection from the adverse effects of AF in animals. To further evaluate the influence of NS on utilization of these two vitamins in humans, levels of Vit A and E were measured by HPLC methods in 655 serum samples collected at 0, 1, and 3 months from a phase 2a clinical trial carried out in 177 healthy Ghanaian volunteers who either received NS 1.5 g/day (low dose), 3.0 g/day (high dose), or placebo for 3 months. The baseline serum levels of Vit A were comparable (P=0.8702) for groups of the placebo (2.09±0.56 µmol/L), the low dose (2.15±0.74 µmol/L), and the high dose (2.14±0.92 µmol/L). No significance was found among groups of low dose (2.28±0.85 µmol/L), high dose (2.21±0.95 µmol/L) and the placebo (2.21±0.57 µmol/L) in 1 month samples (P=0.7324). No significance was found among groups of low dose (2.22±0.87 µmol/L), high dose (2.30±0.71 µmol/L), and the placebo (2.32±0.83 µmol/L) in 3 months samples (P=0.7305). The baseline serum levels of Vit E were also comparable (P=0.6798) for groups of the placebo (16.07±4.74 µmol/L), the low dose (16.40±5.08 µmol/L), and the high dose (15.64±4.97 µmol/L). No significance was found among groups of low dose (17.9±4.99 µmol/L), high dose (17.08±4.83 µmol/L) and the placebo (17.32±4.97 µmol/L) in 1 month samples (P=0.5868). No significance was found among groups of low dose (17.03±4.71 µmol/L), high dose (17.33±4.21 µmol/L), and the placebo (18.01±6.29 µmol/L) in 3 months samples (P=0.7618). Furthermore, levels of Vit A (P=0.3665) and Vit E (P=0.1543) were not statistically significant among the treated groups and the placebo group in samples collected at 1 month post the trial. These results suggest that NS does not affect utilization of Vit A and E in humans.

Keywords
  • Vitamin A,
  • Vitamin E,
  • Novasil Clay,
  • Ghana,
  • Clinical study
Publication Date
March 25, 2007
Citation Information
Z. Wang, Li Xu, Hongxia Guan, X. He, et al.. "Three-Month Clinical Intervention Trial with NovaSil Clay in Ghanaians: No Influence on Utilization Vitamins A and E" Society of Toxicology Annual (46th) Meeting (2007)
Available at: http://works.bepress.com/evans_afriyie-gyawu/48/