Vitamin E Level in Buccal Cells of Arsenicosis Patients

December 4, 2012 updated by: Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

For arsenicosis

  • who drank arsenic contaminated water (>50 µg/L) for more than 6 months
  • having physical signs of moderate degree of melanosis and keratosis

For arsenic exposed control

  • relative or family member of the patient
  • showing no physical signs of melanosis and keratosis
  • share same tube well water for drinking purpose for more than 6 months

For healthy volunteers

  • who drank arsenic safe water (<50 µg/L)
  • live in the same Upazilla
  • have no cutaneous manifestation
  • who voluntarily agree to participate

Exclusion Criteria:

  • tuberculosis, eczema psoriasis, contact dermatitis
  • patients getting treatment of arsenicosis
  • subject who voluntarily do not agree to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arsenicosis patients
Vitamin E (200 IU, caplet) daily orally for 20 weeks
Dietary supplement: Vitamin E
vitamin E (200 IU, caplet) daily orally for 20 weeks
Active Comparator: Arsenic exposed controls
vitamin E (200 IU, caplet) daily orally for 20 weeks
Dietary supplement: Vitamin E
vitamin E (200 IU, caplet) daily orally for 20 weeks
Active Comparator: Heathy volunteers
Vitamin E (200 IU, caplet) daily orally for 20 weeks
Dietary supplement: Vitamin E
vitamin E (200 IU, caplet) daily orally for 20 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 week (baseline), 20 weeks (end)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 week (baseline), 20 weeks (end)
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.
0 week (baseline), 20 weeks (end)
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.
0 week (baseline), 20 weeks (end)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 1, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (Estimate)

December 6, 2012

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSMMU-004-CT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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