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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01442727
Other study ID # TTU-JES-1
Secondary ID 1R21CA117111-01R
Status Completed
Phase Phase 3
First received September 22, 2011
Last updated October 6, 2011
Start date December 2006
Est. completion date April 2009

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Drug:
sodium selenite
200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.
placebo
dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast

Locations

Country Name City State
Bangladesh SETAC Trial Field Office Kalibari town Chandpur District

Sponsors (3)

Lead Sponsor Collaborator
Texas Tech University American Cancer Society, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

Bangladesh, 

Outcome

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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Completed NCT01752972 - Effect of Spirulina on Zinc, Vitamin E and Linoleic Acid Levels in Palm Skin Following Chronic Exposure to Arsenic N/A