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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


Phase 3
12 Years
55 Years
Not Enrolling
Both
Arsenical Melanosis, Arsenical Keratosis, Arsenical Cancers, Arsenicosis, Arsenic Exposure, Arsenic Toxicity, Arsenic Poisoning

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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

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