SETAC Trial Field Office
Kalibari Town, Chandpur District, Bangladesh
NCT Number: NCT01442727
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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Notify Me12 year–55 year
All sexes
Interventional
Phase 3
Kalibari Town, Chandpur District, Bangladesh
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.
Other names: selenium, selenite
dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast
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.
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.
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.
Texas Tech University
Other
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
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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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