Arsenical Keratosis Clinical Trial
— SETACOfficial 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
| Verified date | October 2011 |
| Source | Texas Tech University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Bangladesh: Bangladesh Medical Research Council |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 819 |
| Est. completion date | April 2009 |
| Est. primary completion date | April 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years to 55 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Bangladesh | SETAC Trial Field Office | Kalibari town | Chandpur District |
| Lead Sponsor | Collaborator |
|---|---|
| Texas Tech University | American Cancer Society, Inc., National Cancer Institute (NCI) |
Bangladesh,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | changes in arsenical melanosis | 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. | 0 weeks (baseline), 24 weeks, and 48 weeks (end) | No |
| Secondary | changes in blood arsenic levels | The levels of arsenic in patients' blood was measured to determine whether intervention had a differential effect. | week 0, week 24 and week 48 | No |
| Secondary | changes in urinary arsenic levels | The levels of arsenic in patients' urine was measured to determine whether intervention had a differential effect. | week 0, week 24 and week 48 | No |
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