Clinical Trial: Selenium in the Treatment of Arsenic Toxicity and Cancers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Selenite in the Detoxification of Arsenic and the Prevention of Arsenical Melanosis and Cancers Amongst Bangladeshi Arsenicosis Patients: A 48-week, Randomized, Double-bli

Brief 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.


Detailed Summary:
Sponsor: Texas Tech University

Current Primary Outcome: changes in arsenical melanosis [ Time Frame: 0 weeks (baseline), 24 weeks, and 48 weeks (end) ]

Arsenical melanosis was recorded in 4 quadrants of each patients' torsos using the Dermlite epiluminescence microscopy system. The images were then scored in a blinded, randomized fashion by a dermatologist.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • changes in blood arsenic levels [ Time Frame: week 0, week 24 and week 48 ]
    The levels of arsenic in patients' blood was measured to determine whether intervention had a differential effect.
  • changes in urinary arsenic levels [ Time Frame: week 0, week 24 and week 48 ]
    The levels of arsenic in patients' urine was measured to determine whether intervention had a differential effect.


Original Secondary Outcome: Same as current

Information By: Texas Tech University

Dates:
Date Received: September 22, 2011
Date Started: December 2006
Date Completion:
Last Updated: October 6, 2011
Last Verified: October 2011