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Selenium in the Treatment of Arsenic Toxicity and Cancers

NCT ID: NCT01442727

Last Updated: 2011-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

819 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Arsenical Melanosis Arsenical Keratosis Arsenical Cancers Arsenicosis Arsenic Exposure Arsenic Toxicity Arsenic Poisoning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Patients who receive control (placebo)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast

Selenium

Patients who receive treatment (selenium)

Group Type ACTIVE_COMPARATOR

sodium selenite

Intervention Type DRUG

200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.

Interventions

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sodium selenite

200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.

Intervention Type DRUG

placebo

dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast

Intervention Type DRUG

Other Intervention Names

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selenium selenite

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Texas Tech University

OTHER

Sponsor Role lead

Responsible Party

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Julian Spallholz

Professor of Nutrition & Biochemistry, Division of Nutritional Sciences, College of Human Sciences, Texas Tech University.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julian E Spallholz, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University

Paul F La Porte, PhD

Role: PRINCIPAL_INVESTIGATOR

Pritzker School of Medicine, The University of Chicago

Selim Ahmed, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Institute of Child & Mother Health, Dhaka, Bangladesh

Locations

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SETAC Trial Field Office

Kalibari Town, Chandpur District, Bangladesh

Site Status

Countries

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Bangladesh

Other Identifiers

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1R21CA117111-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ROG-06-098-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TTU-JES-1

Identifier Type: -

Identifier Source: org_study_id