Short-term safety and efficacy of calcium montmorillonite clay (UPSN) in children.

Recently, an association between childhood growth stunting and aflatoxin (AF) exposure has been identified. In Ghana, homemade nutritional supplements often consist of AF-prone commodities. In this study, children were enrolled in a clinical intervention trial to determine the safety and efficacy of Uniform Particle Size NovaSil (UPSN), a refined calcium montmorillonite known to be safe in adults. Participants ingested 0.75 or 1.5 g UPSN or 1.5 g calcium carbonate placebo per day for 14 days. Hematological and serum biochemistry parameters in the UPSN groups were not significantly different from the placebo-controlled group. Importantly, there were no adverse events attributable to UPSN treatment. A significant reduction in urinary metabolite (AFM1) was observed in the high-dose group compared with placebo. Results indicate that UPSN is safe for children at doses up to 1.5 g/day for a period of 2 weeks and can reduce exposure to AFs, resulting in increased quality and efficacy of contaminated foods.

Reduction in the urinary aflatoxin M1 biomarker as an early indicator of the efficacy of dietary interventions to reduce exposure to aflatoxins.

Aflatoxin B1 is a persistent public health issue in Ghana. Assessment of AFB1 intervention efficacy is currently dependent on long-term biomarkers. This study was designed to determine whether daily AFM1 biomarker levels could be utilized as an early detection method for intervention efficacy. Participants were treated with a refined calcium montmorillonite clay (UPSN) or a placebo (calcium carbonate) in a crossover study. Urine samples were assessed for AFM1 levels daily. UPSN treatment reduced AFM1 biomarkers by 55% compared to the placebo. This is the first study to show that daily urinary AFM1 levels can be used as a biomarker of internal aflatoxin B1 exposure in short-term intervention trials to determine efficacy.

HIV and hepatocellular and esophageal carcinomas related to consumption of mycotoxin-prone foods in sub-Saharan Africa.

BACKGROUND: Promotion of the HIV epidemic by aflatoxin is postulated but not yet established. Sub-Saharan populations commonly consume food contaminated by mycotoxins, particularly aflatoxins (predominantly found in peanut, maize, rice, and cassava) and fumonisins, which occur primarily in maize. Aflatoxin promotes hepatocellular cancer, and fumonisin may promote esophageal cancer. OBJECTIVES: This analysis was undertaken to test the hypotheses that consumption of mycotoxin-prone staple foods is 1) related to the incidence of HIV infection in Africa and 2) related to "signature" cancer rates confirming exposure to aflatoxins and fumonisins. DESIGN: World Health Organization data for causes of death and the Food and Agriculture Organization per capita consumption data for commodities in sub-Saharan Africa were used. Per capita Gross Domestic Product and the percentage of Muslims (%Muslim) were the socioeconomic data sets exploited. Relations between causes of mortality, consumption of mycotoxin-prone foods, and socioeconomic variables were evaluated. Models for HIV transmission as a function of maize consumption and %Muslim were estimated. RESULTS: HIV and esophageal cancer deaths were significantly related to maize but were inversely related to %Muslim and rice consumption. HIV infections were minimized (74 compared with 435/100,000 people; odds ratio: 2.41; 95% CI: 1.73, 3.24; P < or = 0.0001) by the combination of low maize consumption and above-median % Muslim. Hepatocellular cancer deaths were positively related to rice but negatively related to maize consumption. CONCLUSIONS: HIV transmission frequency is positively associated with maize consumption in Africa. The relation between cancer and food suggests that fumonisin contamination rather than aflatoxin is the most likely factor in maize promoting HIV. Changes to the quality of maize may avoid up to 1,000,000 transmissions of HIV annually.

PAH exposure in a Ghanaian population at high risk for aflatoxicosis.

It was postulated that a population in sub-Saharan Africa, known to be at high risk for aflatoxicosis due to frequent ingestion of aflatoxin (AF)-contaminated foods could also be exposed to polycyclic aromatic hydrocarbons (PAHs) from a variety of environmental sources. Previously, participants in this population were shown to be highly exposed to AFs, and this exposure was significantly reduced by intervention with NovaSil clay (NS). Objectives of this study were 1) to assess PAH exposure in participants from the AF study using urinary biomarker 1-hydroxypyrene (1-OHP); 2) examine the effect of NS clay and placebo (cellulose) treatment on 1-OHP levels; and 3) determine potential association(s) between AF and PAH exposures. A clinical trial was conducted in 177 Ghanaians who received either NS capsules as high dose or low dose, or placebo (cellulose) for a period of 3 months. At the start and end of the study, urine samples were analyzed for 1-OHP. Of the 279 total samples, 98.9% had detectable levels of 1-OHP. Median 1-OHP excretion in nonsmokers was 0.64 micromol/mol creatinine at baseline and 0.69 micromol/mol creatinine after 3 months. Samples collected at both time points did not show significant differences between placebo and NS-treated groups. There was no linear correlation between 1-OHP and AF-albumin adduct levels. Results show that this population is highly exposed to PAHs (and AFs), that NS and cellulose treatment had no statistically significant effect on 1-OHP levels, and that this urinary biomarker was not linearly related with AF exposure.

Evaluation of efficacy and safety of a herbal medicine used for the treatment of malaria.

Resistance of Plasmodium falciparum to chloroquine has been reported in several countries. Other anti-malarial drugs in use are expensive and not readily accessible to most people in malaria endemic countries. This has led to renewed interest in the development of herbal medicines that have the potential to treat malaria with little or no side effects. This study obtained a preliminary information on the safety and effectiveness of a plant decoction (AM-1), used in treating malaria. The AM-1 is formulated from Jatropha curcas, Gossypium hirsutum, Physalis angulata and Delonix regia. Patients with suspected malaria attending a herbal clinic were enrolled in the study on voluntary basis. They were hospitalized for treatment, clinical observation, biochemical and haematological monitoring, and parasite clearance while on AM-1. In addition male and female Sprague Dawley rats were used to evaluate the acute and subchronic toxicity effects of AM-1. The AM-1 eliminated malaria parasites (Plasmodium falciparum and Plasmodium malarie) from the peripheral blood of patients with malaria. In addition the AM-1 did not show any undesired effects in the patients as well as in laboratory rats. The AM-1, however, showed differential effect on the activities of selected cytochrome P450 isozymes (7-pentoxyresorufin-O-depentylation, 7-ethoxyresorufin-O-deethylation and p-nitrophenol hydroxylase) in relation to sex of the laboratory rats. These results indicate that AM-1 could be used to treat malaria. However, it could precipitate interactions with other drugs via their biotransformation and elimination. The obtained data warrant further studies in a large number of malaria subjects with monitoring for possible drug interactions.