Phase 1 clinical study of the acute and subacute safety and proof-of-concept efficacy of carbohydrate-derived fulvic acid

Abstract

BackgroundThe purpose of this research was to determine the acute and subacute safety and proof-of-concept efficacy of carbohydrate-derived fulvic acid (CHD-FA).MethodsIn this double-blind study, 30 male volunteers with predetermined atopy were randomly assigned to either Group A or Group B, each consisting of 15 participants. In part 1 of the study, the groups were administered increasing amounts of CHD-FA, ranging from 5 mL to 40 mL, provided that no adverse events had occurred at the previous dosage. In part 2, Group A participants received 20 mL of 3.8% CHD-FA twice daily for 3 days and were monitored for a week. Because no adverse events occurred, Group B received 40 mL of 3.8% CHD-FA twice daily for a period of 3 days. In part 3, both groups received either 40 mL of 3.8% CHD-FA or placebo twice daily for a period of one week, followed by a one-week washout period before crossover to the alternative treatment schedule. Parameters used to establish safety were electrocardiography, a physical examination, a health questionnaire, and hematology and biochemistry, determined at baseline, during regular calculated intervals, and at the end of each part of the study. A skin prick test was done as part of the screening process and, from the result, the allergen the participant was most allergic to was then selected, along with the positive histamine and negative control to be repeated at the start and end of each respective stage.ResultsSafety parameters remained constant throughout the trial. A significant decrease in skin prick test results was observed.ConclusionNo severe adverse events occurred, establishing that CHD-FA to be safe at doses up to 40 mL twice daily for a week and that at this dosage CHD-FA acts as an anti-inflammatory agent. These findings confirm earlier animal data.

A Comprehensive Toxicological Assessment of Fulvic Acid

“…Interestingly, oral administration of FA ≥100 mg/kg effectively reduced carrageenan-induced paw edema in rats [ 32 ]. In another study, carbohydrate-derived FA showed potent activity against fungal pathogens with lower minimum inhibitory concentration (MIC) values (equal or less than 5 mg/mL), while the cytokine interleukin 6 mediated-inflammation response was significantly inhibited [ 14 ]. In the human clinical toxicity assessment study, FA is indicated to be safe in humans at a daily dosage of 1.8 g (equal to purified FA at 30 mg/BW/day) [ 5 ].…”

“…Fulvic acid (FA), one fraction of HA, has a lower molecular weight and a higher oxygen content than other HA components [ 3 ]. Several studies showed that FA is a potential safe natural active ingredient of HA [ 14 , 15 ]. As a dietary supplementation, FA can be found in a liquid form as a component of mineral colloids.…”

“…In animal production, many reports indicated that the FA could be used as a feed additive, protect against infections and poisoning, and improve utilization of nutrients, growth performance, and meat quality of producing animals [ 19 – 21 ]. Besides, FA could also be used to treat the infections caused by drug-resistant pathogens [ 14 , 15 , 22 ]. Although the previous studies had shown that HA may have the potential genotoxicity through in vitro testing [ 23 , 24 ], there is very little information on the toxicological effect of FA.…”

The Antiinflammatory Properties of Humic Substances: A Mini Review

“…A significant decrease in the skin prick test was observed (Table ). It was concluded that this product was safe at these dosages (Gandy et al, ).…”

New strategic insights into managing fungal biofilms

“…An initial randomized double blind controlled trial indicated that fulvic acid was well-tolerated in patients with eczema, where side effects were minimal and severity and erythema were significantly reduced compared with the placebo control ( Gandy et al, 2011 ). A subsequent phase 1 clinical study carried out to determine the safety profile of CHD-FA, showed that this agent was able to elicit anti-inflammatory properties in addition to being non-toxic when used as an oral formulation ( Gandy et al, 2012 ). This anti-inflammatory activity was also shown in a rat wound model, where the use of a topical cream enhanced wound healing and was non-toxic during both acute and chronic treatments ( Sabi et al, 2012 ).…”