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Completed

NCT Number: NCT01743066

Vitamin E Level in Buccal Cells of Arsenicosis Patients

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin E

Dietary Supplement

vitamin E (200 IU, caplet) daily orally for 20 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 6, 2012
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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