Selenium in the Treatment of Arsenic Toxicity and Cancers

Phase 3

Completed

• Conditions: Arsenical Melanosis; Arsenical Keratosis; Arsenical Cancers; Arsenicosis; Arsenic Exposure; Arsenic Toxicity; Arsenic Poisoning
• Interventions: Drug: placebo; Drug: sodium selenite

• Registration Number: NCT01442727
• Lead Sponsor: Texas Tech University

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 Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-06
• Last Update Posted: 2011-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 819

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Patients who receive control (placebo)
Selenium	sodium selenite	Patients who receive treatment (selenium)

Primary Outcome Measures

Name	Time	Method
changes in arsenical melanosis	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.

Secondary Outcome Measures

Name	Time	Method
changes in blood arsenic levels	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	week 0, week 24 and week 48	The levels of arsenic in patients' urine was measured to determine whether intervention had a differential effect.

Trial Locations

Locations (1)

SETAC Trial Field Office; 🇧🇩 Kalibari town, Chandpur District, Bangladesh