Establishing EDI for a Clinical Trial of a Treatment for Chikungunya

Abstract

Ellagic acid (EA) is a polyphenolic compound with antiviral activity against chikungunya, a rapidly spreading new tropical disease transmitted to humans by mosquitoes and now affecting millions worldwide. The most common symptoms of chikungunya virus infection are fever and joint pain. Other manifestations of infection can include encephalitis and an arthritic joint swelling with pain that may persist for months or years after the initial infection. The disease has recently spread to the U.S.A., with locally-transmitted cases of chikungunya virus reported in Florida. There is no approved vaccine to prevent or medicine to treat chikungunya virus infections. In this study, the Estimated Daily Intake (EDI) of EA from the food supply established using the National Health and Nutrition Examination Survey (NHANES) is used to set a maximum dose of an EA formulation for a high priority clinical trial.