Trial | NCT01442727  Report issue

Title

Selenium in the Treatment of Arsenic Toxicity and Cancers
Selenite in the Detoxification of Arsenic and the Prevention of Arsenical Melanosis and Cancers Amongst Bangladeshi Arsenicosis Patients: A 48-week, Randomized, Double-blinded, Placebo-controlled Phase III Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    selenium ...

  • Study Participants

    819
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.
Study Started
Dec 31
2006
Primary Completion
Apr 30
2009
Study Completion
Apr 30
2009
Last Update
Oct 07
2011
Estimate

Drug sodium selenite

200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.

  • Other names: selenium, selenite

Drug placebo

dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast

Placebo Placebo Comparator

Patients who receive control (placebo)

Selenium Active Comparator

Patients who receive treatment (selenium)

Criteria 

Inclusion Criteria:

Resident of Bangladesh in an arsenic-affected region (Chandpur)
Age between 12 and 55
Exposure to arsenic in home drinking water greater than 50 ug/L.
Arsenical melanosis on the torso confirmed by epiluminescence microscopy

Exclusion Criteria:

Recent history or plans to consume selenium-containing supplements
Anticipated change in home drinking water supply during study period
No Results Posted