Selenium in the Treatment of Arsenic Toxicity and Cancers (SETAC)
This study has been completed.
Sponsor:
Texas Tech University
Collaborators:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Julian Spallholz, Texas Tech University
ClinicalTrials.gov Identifier:
NCT01442727
First received: September 22, 2011
Last updated: October 6, 2011
Last verified: October 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Arsenical Melanosis Arsenical Keratosis Arsenical Cancers Arsenicosis Arsenic Exposure Arsenic Toxicity Arsenic Poisoning |
Drug: sodium selenite Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Texas Tech University:
Primary Outcome Measures:
- changes in arsenical melanosis [ Time Frame: 0 weeks (baseline), 24 weeks, and 48 weeks (end) ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- changes in blood arsenic levels [ Time Frame: week 0, week 24 and week 48 ] [ Designated as safety issue: No ]The levels of arsenic in patients' blood was measured to determine whether intervention had a differential effect.
- changes in urinary arsenic levels [ Time Frame: week 0, week 24 and week 48 ] [ Designated as safety issue: No ]The levels of arsenic in patients' urine was measured to determine whether intervention had a differential effect.
| Enrollment: | 819 |
| Study Start Date: | December 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Patients who receive control (placebo)
|
Drug: placebo
dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast
|
|
Active Comparator: Selenium
Patients who receive treatment (selenium)
|
Drug: sodium selenite
200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.
Other Names:
|
Eligibility| Ages Eligible for Study: | 12 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442727
Locations
| Bangladesh | |
| SETAC Trial Field Office | |
| Kalibari town, Chandpur District, Bangladesh | |
Sponsors and Collaborators
Texas Tech University
American Cancer Society, Inc.
Investigators
| Principal Investigator: | Julian E Spallholz, PhD | Texas Tech University |
| Principal Investigator: | Paul F La Porte, PhD | Pritzker School of Medicine, The University of Chicago |
| Principal Investigator: | Selim Ahmed, MBBS, FCPS | Institute of Child & Mother Health, Dhaka, Bangladesh |
More Information
Additional Information:
No publications provided
| Responsible Party: | Julian Spallholz, Professor of Nutrition & Biochemistry, Division of Nutritional Sciences, College of Human Sciences, Texas Tech University., Texas Tech University |
| ClinicalTrials.gov Identifier: | NCT01442727 History of Changes |
| Other Study ID Numbers: | TTU-JES-1, 1R21CA117111-01, ROG-06-098-01 |
| Study First Received: | September 22, 2011 |
| Last Updated: | October 6, 2011 |
| Health Authority: | Bangladesh: Bangladesh Medical Research Council |
Keywords provided by Texas Tech University:
|
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 |
Additional relevant MeSH terms:
|
Keratosis Keratosis, Actinic Melanosis Poisoning Arsenic Poisoning Skin Diseases Precancerous Conditions Neoplasms Hyperpigmentation Pigmentation Disorders Substance-Related Disorders Heavy Metal Poisoning, Nervous System |
Neurotoxicity Syndromes Nervous System Diseases Selenium Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013