Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arsenical Cancers | — | UNRESOLVED | — |
| Arsenical Keratosis | — | UNRESOLVED | — |
| Arsenical Melanosis | — | UNRESOLVED | — |
| Arsenic Exposure | — | UNRESOLVED | — |
| Arsenicosis | — | UNRESOLVED | — |
| Arsenic Poisoning | — | UNRESOLVED | — |
| Arsenic Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Drug | — | UNRESOLVED |
| sodium selenite | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients who receive control (placebo)
- interventionNames
- Drug: placebo
- type
- ACTIVE_COMPARATOR
- label
- Selenium
- description
- Patients who receive treatment (selenium)
- interventionNames
- Drug: sodium selenite
Primary outcomes (1)
- measure
- changes in arsenical melanosis
- timeFrame
- 0 weeks (baseline), 24 weeks, and 48 weeks (end)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available