Clinical trial NCT01442727: Selenium in the Treatment of Arsenic Toxicity and Cancers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arsenical Melanosis
Arsenical Keratosis
Arsenical Cancers
Arsenicosis
Arsenic Exposure
Arsenic Toxicity
Arsenic Poisoning
Keywords: arsenical melanosis
arsenical melanoses
arsenical keratosis
arsenical keratoses
arsenical cancer
arsenic cancers
arsenic
arsenicosis
arsenic exposure
arsenic toxicity
arsenic poisoning
drinking water
selenium
selenite
sodium selenite
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: American Cancer Society, Inc.
First posted: 2011-09-28
Enrollment: 819
Sex: ALL
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: changes in arsenical melanosis
timeFrame: 0 weeks (baseline), 24 weeks, and 48 weeks (end)
Secondary outcomes:
measure: changes in blood arsenic levels
timeFrame: week 0, week 24 and week 48
measure: changes in urinary arsenic levels
timeFrame: week 0, week 24 and week 48
Other outcomes:
Locations:
city: Kalibari town
country: Bangladesh
facility: SETAC Trial Field Office
state: Chandpur District
Study officials:
affiliation: Texas Tech University
name: Julian E Spallholz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pritzker School of Medicine, The University of Chicago
name: Paul F La Porte, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Child & Mother Health, Dhaka, Bangladesh
name: Selim Ahmed, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
References: