NovaSil clay does not affect the concentrations of vitamins A and E and nutrient minerals in serum samples from Ghanaians at high risk for aflatoxicosis

Abstract

To assess the potential interference of NovaSil (NS) clay with micronutrients in humans, vitamins A and E and minerals (15 nutrient and 15 non-nutrient minerals) were measured in serum samples from a 3-month intervention trial with NS. Participants (n = 177) were randomly divided into three groups that received 3.0 g NS day⁻¹ (high dose, HD), 1.5 g NS day⁻¹ (low dose, LD), or placebo (PL). Levels of vitamins A and E in serum were comparable among the three study groups at baseline, 1 month and 3 months of NS intervention. Gender-stratified non-parametric mixed-effect model analysis showed no significant effects of dose and dose–time interaction for levels of vitamins A and E. A significant time effect was detected; however, it was limited to an increase in vitamin E in the male participants over the course of the study. No significant differences were found in levels of the nutrient and non-nutrient minerals between the HD and PL groups at baseline and 3 months of NS intervention, except for strontium levels. Strontium was significantly increased (p < 0.001) in the HD group (male = 113.65 ± 28.00 µg l⁻¹; female = 116.40 ± 24.26 µg l⁻¹) compared with the PL group (male = 83.55 ± 39.90 µg l⁻¹; female = 90.47 ± 25.68 µg l⁻¹) following the 3-month intervention with NS. These results, combined with safety and efficacy data, confirm that NS clay is highly effective in reducing aflatoxin exposure and acts as a selective enterosorbent that does not affect the serum concentrations of important vitamins and nutrient minerals in humans.

Keywords:

• NovaSil clay
• aflatoxin
• enterosorbent
• micronutrients
• vitamin A
• vitamin E
• minerals
• heavy metals

Acknowledgements

The authors would like to express their appreciation to the District Health Director, Dr Amponsah-Achiano, the on-site physicians, technicians, and other health personnel at Ejura District Hospital for their assistance during the physical examinations and blood collections. Special thanks are extended to the volunteers and study subjects whose participation made this study possible. They appreciate Abraham Robinson for editing the manuscript. This work was supported by a research grant from the US Agency for International Development (USAID; Grant No. LAG-G-00-96-90013-00) through Peanut CRSP of the University of Georgia. E. Afriyie-Gyawu and Z. Wang made equal contributions to the study.