Vitamin E Level in Buccal Cells of Arsenicosis Patients

NCT ID: NCT01743066

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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

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Chronic Arsenic Poisoning

Keywords

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Arsenic Arsenicosis Buccal cells Serum Vitamin E Cholesterol

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arsenicosis patients

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

Group Type EXPERIMENTAL

Vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

Arsenic exposed controls

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

Group Type ACTIVE_COMPARATOR

Vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

Heathy volunteers

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

Group Type ACTIVE_COMPARATOR

Vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Vitamin E

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Prof. Mir Misbahuddin

Prof. and Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

Other Identifiers

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BSMMU-004-CT

Identifier Type: -

Identifier Source: org_study_id