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Completed

NCT Number: NCT01442727

Selenium in the Treatment of Arsenic Toxicity and Cancers

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.

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Key information

Age range

12 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SETAC Trial Field Office

Kalibari Town, Chandpur District, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sodium selenite

Drug

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

Other names: selenium, selenite

Placebo

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Collaborators

  • American Cancer Society, Inc.
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: SETAC

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 28, 2011
Registry last updated
Oct 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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