Selenium and Arsenic Pharmacodynamics

Summary

This clinical trial should prove that selenium can treat arsenic exposure in humans by promoting excretion. The new trial differs from previous trials in that participants will be maintained in a local clinic and provided with food and water from their home villages. The purpose of this study to determine the fate of selenium supplements in feces, urine and blood of volunteers living in conditions of high arsenic load in drinking water. The use of a clinic will enable monitoring of all intake and excretion of both arsenic and selenium, and will ensure that participants take their selenium doses or placebo as appropriate. This proof of concept is absolutely essential groundwork for any remediation strategy involving selenium supplements.

Conditions

• Arsenic Poisoning Chronic

Interventions

DIETARY_SUPPLEMENT

Anhydrous selenite

40 volunteer sufferers will be housed in a local private in-patient clinic where they will follow a fixed, communal diet consisting of drinking water and meals from their village. On a 6th day we will give a single dose of placebo (sodium chloride) or anhydrous sodium selenite (0.8mg selenium) labelled with a non-radioactive naturally occurring isotope (77Se), to distinguish it from selenium already in the body.

DIETARY_SUPPLEMENT

Sodium chloride

40 volunteer sufferers will be housed in a local private in-patient clinic where they will follow a fixed, communal diet consisting of drinking water and meals from their village. On a 6th day we will give a single dose of placebo (sodium chloride) or anhydrous sodium selenite (0.8mg selenium) labelled with a non-radioactive naturally occurring isotope (77Se), to distinguish it from selenium already in the body.

Sponsors & Collaborators

• University of Chicago

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• Emory University

  collaborator OTHER

• Wagner College, Staten Island, NY, USA

  collaborator UNKNOWN

• Applied Speciation and Consulting LLC, WA, USA

  collaborator UNKNOWN

• University of Saskatchewan

  lead OTHER

Principal Investigators

• Graham N George, D.Phil. · University of Saskatchewan

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-02-10

Primary Completion

2016-12-19

Completion

2017-01-19

Countries

• Bangladesh

Study Locations