Selenium in the Treatment of Arsenic Toxicity and Cancers
Selenium in the Treatment of Arsenic Toxicity and Cancers
NCT ID: NCT01442727 Phase: PHASE3 Status: COMPLETED Enrollment: 819 Completion: 2009-04
Conditions
Arsenical Melanosis, Arsenical Keratosis, Arsenical Cancers, Arsenicosis, Arsenic Exposure, Arsenic Toxicity, Arsenic Poisoning
Interventions
sodium selenite, placebo
Summary
Context: Approximately 100 million people throughout the world consume water contaminated with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected regions. There are no proven therapies for treating chronic arsenic toxicity or for preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a variety of animal models. The investigators have recently shown in animals and humans that this effect is mediated by the formation of [(GS)2AsSe]- , the seleno-bis(S-glutathionyl) arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two Phase II studies in China and Bangladesh have suggested clinical benefit to selenium supplementation in arsenicosis patients.
Objective: To assess whether daily selenium supplementation counters arsenic toxicity in patients exposed to drinking water arsenic. If proven effective, selenium supplementation might be safely and cost-effectively implemented in the worst-affected localities.
Primary Outcome
changes in arsenical melanosis