Selenium and Arsenic Pharmacodynamics (NCT02377635) | Clinical Trial Compass
CompletedPhase 1/2
Selenium and Arsenic Pharmacodynamics
Bangladesh40 participantsStarted 2015-02-10
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexMALE
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Inclusion criteria
✓. healthy adult (18-65 years of age) male Bangladeshi volunteers from Laksam Upazila,
✓. who are exposed to arsenic through their normal source of drinking water;
✓. who are otherwise healthy except that show some signs of chronic arsenic toxicity (arsenicosis);
✓. have not consumed selenium-containing supplements with last 6 months;
✓. not concurrently participating or have participated in any other clinical trial within at least 30 days of registration to the current trial.
Exclusion criteria
✕. Recent history of consuming selenium, concurrent participation or recent participation in any other clinical trial within at least 30 days of registration to the current trial, and people who recently moved in the area.
✕. Prior clinical trial, recruits will undertake a medical examination by physician. Since chronic kidney disease and alcoholic and viral cirrhosis are common in rural Bangladesh and both conditions might impact selenium and arsenic metabolism, recruits will also be screened through a baseline CMP (Comprehensive Metabolic Panel) , CBC (Complete Blood Count), and INR (International Normalized Ratio of Prothrombin Time as Liver Function Test) panel. Evidence or history of significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, musculoskeletal, immunologic, neurologic or dermatologic disease (including drug allergies that are clinically significant) which, by opinion of investigators, could pose a risk to the safety of the individual or the valid conduct of the study will exclude recruits from the participation.
✕. Current evidence of or history of cancer; evidence of hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection upon serological testing; evidence of active communicable disease or febrile illness (e.g., bronchopulmonary, urinary or gastrointestinal) within 7 days prior to study will exclude recruits from participation.