Clinical Trial: Vitamin E Level in Buccal Cells of Arsenicosis Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Vitamin E Level in Buccal Cells of Arsenicosis Patients Following Vitamin E Supplementation

Brief 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.

Detailed Summary: 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.
Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Current Primary Outcome: Change in the amount of vitamin E in buccal cells [ Time Frame: 0 week (baseline), 20 weeks (end) ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in the amount of cholesterol in buccal cells [ Time Frame: 0 week (baseline), 20 weeks (end) ]
    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.
  • Changes in the concentration of vitamin E in serum [ Time Frame: 0 week (baseline), 20 weeks (end) ]
    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.
  • Changes in the concentration of cholesterol in serum [ Time Frame: 0 week (baseline), 20 weeks (end) ]
    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.


Original Secondary Outcome: Same as current

Information By: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Dates:
Date Received: December 1, 2012
Date Started: October 2010
Date Completion:
Last Updated: December 4, 2012
Last Verified: December 2012