search
Back to results

Selenium in the Treatment of Arsenic Toxicity and Cancers (SETAC)

Primary Purpose

Arsenical Melanosis, Arsenical Keratosis, Arsenical Cancers

Status
Completed
Phase
Phase 3
Locations
Bangladesh
Study Type
Interventional
Intervention
sodium selenite
placebo
Sponsored by
Texas Tech University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arsenical Melanosis focused on measuring 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

Eligibility Criteria

12 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SETAC Trial Field Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Selenium

Arm Description

Patients who receive control (placebo)

Patients who receive treatment (selenium)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

changes in blood arsenic levels
The levels of arsenic in patients' blood was measured to determine whether intervention had a differential effect.
changes in urinary arsenic levels
The levels of arsenic in patients' urine was measured to determine whether intervention had a differential effect.

Full Information

First Posted
September 22, 2011
Last Updated
October 6, 2011
Sponsor
Texas Tech University
Collaborators
National Cancer Institute (NCI), American Cancer Society, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01442727
Brief Title
Selenium in the Treatment of Arsenic Toxicity and Cancers
Acronym
SETAC
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

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University
Collaborators
National Cancer Institute (NCI), American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
819 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients who receive control (placebo)
Arm Title
Selenium
Arm Type
Active Comparator
Arm Description
Patients who receive treatment (selenium)
Intervention Type
Drug
Intervention Name(s)
sodium selenite
Other Intervention Name(s)
selenium, selenite
Intervention Description
200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast
Primary Outcome Measure Information:
Title
changes in arsenical melanosis
Description
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
0 weeks (baseline), 24 weeks, and 48 weeks (end)
Secondary Outcome Measure Information:
Title
changes in blood arsenic levels
Description
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
Title
changes in urinary arsenic levels
Description
The levels of arsenic in patients' urine was measured to determine whether intervention had a differential effect.
Time Frame
week 0, week 24 and week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian E Spallholz, PhD
Organizational Affiliation
Texas Tech University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul F La Porte, PhD
Organizational Affiliation
Pritzker School of Medicine, The University of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Selim Ahmed, MBBS, FCPS
Organizational Affiliation
Institute of Child & Mother Health, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
SETAC Trial Field Office
City
Kalibari town
State/Province
Chandpur District
Country
Bangladesh

12. IPD Sharing Statement

Learn more about this trial

Selenium in the Treatment of Arsenic Toxicity and Cancers

We'll reach out to this number within 24 hrs