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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA117111-01 | U.S. NIH Grant/Contract | View source | |
| ROG-06-098-01 | Other Grant/Funding Number | The American Cancer Society |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| American Cancer Society, Inc. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients who receive control (placebo) |
|
| Selenium | Active Comparator | Patients who receive treatment (selenium) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium selenite | Drug | 200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| changes in urinary arsenic levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SETAC Trial Field Office | Kalibari Town | Chandpur District | Bangladesh |
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| ID | Term |
|---|---|
| D020261 | Arsenic Poisoning |
| ID | Term |
|---|---|
| D020260 | Heavy Metal Poisoning, Nervous System |
| D020258 | Neurotoxicity Syndromes |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
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| ID | Term |
|---|---|
| D018038 | Sodium Selenite |
| D012643 | Selenium |
| D020887 | Selenious Acid |
| ID | Term |
|---|---|
| D018036 | Selenium Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D018011 | Chalcogens |
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| placebo | Drug | dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast |
|
The levels of arsenic in patients' urine was measured to determine whether intervention had a differential effect.
| week 0, week 24 and week 48 |
| D064419 | Chemically-Induced Disorders |
| D004602 |
| Elements |
| D008903 | Minerals |