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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT01743066
Study type Interventional
Source Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Contact
Status Completed
Phase N/A
Start date October 2010
Completion date June 2011

See also
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Completed NCT03127657 - Effect of Cock's Comb Extract in the Treatment of Arsenical Skin Lesion Phase 2
Completed NCT01726426 - Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics N/A