Clinical Trials Directory

Trials / Completed

CompletedNCT01743066

Vitamin E Level in Buccal Cells of Arsenicosis Patients

Vitamin E Level in Buccal Cells of Arsenicosis Patients Following Vitamin E Supplementation

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

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 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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTVitamin Evitamin E (200 IU, caplet) daily orally for 20 weeks

Timeline

Start date
2010-10-01
Primary completion
2011-06-01
Completion
2011-06-01
First posted
2012-12-06
Last updated
2012-12-06

Locations

1 site across 1 country: Bangladesh

Source: ClinicalTrials.gov record NCT01743066. Inclusion in this directory is not an endorsement.