Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
changes in arsenical melanosis
Outcome 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.
Outcome Time Frame:
0 weeks (baseline), 24 weeks, and 48 weeks (end)
Safety Issue:
No
Principal Investigator
Julian E Spallholz, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Texas Tech University
Authority:
Bangladesh: Bangladesh Medical Research Council
Study ID:
TTU-JES-1
NCT ID:
NCT01442727
Start Date:
December 2006
Completion Date:
April 2009
Related Keywords:
- Arsenical Melanosis
- Arsenical Keratosis
- Arsenical Cancers
- Arsenicosis
- Arsenic Exposure
- Arsenic Toxicity
- Arsenic Poisoning
- 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
- Keratosis
- Keratosis, Actinic
- Melanosis
- Poisoning
- Arsenic Poisoning