The medicinal properties and applications of a carbohydrate derived fulvic acid

Abstract

Background: Carbohydrate derived fulvic acid (CHD-FA) is a synthetic heavy metal free fulvic acid. Although CHD-FA has been suggested as a nutritional supplement and even a medication, there is currently no data available with regards to the systemic kinetics of CHDFA when ingested orally. Fulvic acid has shown equivalence when compared to diclofenac sodium and betamethasone in a murine hypersensitivity model when applied topically with no adverse side effects. Data from several animal studies indicate that fulvic acid administered topically or orally is safe and effective as an anti-inflammatory agent. Human in vivo safety and efficacy as well as potential in vitro genotoxicity still need to be assessed. Aim: To determine whether carbohydrate derived fulvic acid shows any genotoxic effects and whether it is safe, clinically effective as an anti-inflammatory and attempt to establish a suitable CHD-FA marker for kinetic studies. Methods: Genotoxicity was determined via an in vitro micronucleus assay. Systemic and topical safety and efficacy of CHD-FA was established via two limited participant, double blind, randomised, placebo controlled clinical trials. One to determine safety and efficacy in 30 adult male volunteers with a predetermined atopic hypersensitivity, using a skin prick test, and the second trial to test topical safety and efficacy in 40 patients suffering from atopic dermatitis. LC-MS/MS assays were conducted in order to determine whether a unique or dominant ionic analyte could be found in plasma. Discussion: In the in vitro genotoxicity tests, CHD-FA compared closely to that of the negative control with respect to the number of micronuclei observed. All tested in vivo safety parameters proved to remain constant throughout both the clinical trials. A significant decrease in flare was observed in CHD-FA treated patients following a skin prick challenge. Due to the complexity of the mass spectral fingerprints of both plasma and the fulvic acid no suitable CHD-FA markers were found. Conclusion: No genotoxicity was observed for CHD-FA treated cells. No severe adverse events occurred in either the oral or topically administered CHD-FA trials, proving CHD-FA to be systemically and topically safe. A significant decrease in wheal formation in the skin prick test, and a significant clinical improvement in atopic dermatitis compared to placebo were observed implicating that CHD-FA may act as an anti-inflammatory agent in vivo in humans. No suitable CHD-FA markers for pharmacokinetic studies in human plasma could be identified.