An interventional study of Vitamin E in Chronic Arsenic Poisoning, sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. Completed at 1 site in Bangladesh. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-06.
Sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Not applicable, Interventional, and Basic science
To understand the pathogenesis of chronic arsenic toxicity, the investigators need to know the levels of vitamin E in patients chronically exposed to high concentration of arsenic and if changes are found, what happens when supplemented with vitamin E. The buccal cells and serum of patients will be collected for the estimation of vitamin E both before and after supplementation with vitamin E. Similar samples will be collected from similar number of arsenic exposed controls and healthy volunteers for comparison.
Chronic consumption of arsenic through water (drinking and cooking) and food leads to accumulation of arsenic within the cell. We usually give emphasis on the skin manifestations (melanosis and keratosis) of arsenicosis that is diagnosed first. Other manifestations remain un-diagnosed or diagnosed later. The severe form is the development of cancer in different organs mainly skin, lungs and urinary bladder. To understand the pathophysiology of the development of clinical manifestations appearing in the skin first, we need to understand interior of cells other than skin. One of the dietary supplements, vitamin E is found to be effective in improving the clinical signs/symptoms of melanosis and keratosis. Buccal cells are also exposed to arsenic and easy to collect. To understand the pathogenesis, we need to know the levels of vitamin E in patients of arsenicosis and if changes, what happens when supplemented with vitamin E. The buccal cells and serum of 20 patients will be collected for the estimation of vitamin E both before and after supplementation with vitamin E (200 IU, caplet) daily orally for 20 weeks. Similar samples will be collected from 20 arsenic exposed controls and 20 healthy volunteers for comparison.
209 studies on the registry are indexed under Poisoning; 26 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 104 interventional studies indexed under Poisoning.
Browse Poisoning studies →Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh is the lead sponsor of 126 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For arsenicosis
For arsenic exposed control
For healthy volunteers
Exclusion Criteria:
Vitamin E (200 IU, caplet) daily orally for 20 weeks
Dietary Supplement: Vitamin E
vitamin E (200 IU, caplet) daily orally for 20 weeks
Dietary Supplement: Vitamin E
Vitamin E (200 IU, caplet) daily orally for 20 weeks
Dietary Supplement: Vitamin E
vitamin E (200 IU, caplet) daily orally for 20 weeks
Change in the amount of vitamin E in buccal cells
Changes in the amount of vitamin E in buccal cells of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Time frame: 0 week (baseline), 20 weeks (end)
Changes in the amount of cholesterol in buccal cells
Changes in the amount of cholesterol in buccal cells of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Time frame: 0 week (baseline), 20 weeks (end)
Changes in the concentration of vitamin E in serum
Changes in the concentration of vitamin E in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Time frame: 0 week (baseline), 20 weeks (end)
Changes in the concentration of cholesterol in serum
Changes in the concentration of cholesterol in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Time frame: 0 week (baseline), 20 weeks (end)
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Arsenic Poisoning
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh