Vitamin E Level in Buccal Cells of Arsenicosis Patients

NCT01743066 | Completed

• 1 other identifier: BSMMU-004-CT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Arsenic Poisoning

Keywords

Arsenic; Arsenicosis; Buccal cells; Serum; Vitamin E; Cholesterol

Outcome Measures

Primary Outcomes (1)

• Change in the amount of vitamin E in buccal cells

  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 Outcomes (3)

• Changes in the amount of cholesterol in buccal cells

  0 week (baseline), 20 weeks (end)

• Changes in the concentration of vitamin E in serum

  0 week (baseline), 20 weeks (end)

• Changes in the concentration of cholesterol in serum

  0 week (baseline), 20 weeks (end)

Study Arms (3)

Arsenicosis patients

EXPERIMENTAL

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

Dietary Supplement: Vitamin E

Arsenic exposed controls

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin E

Heathy volunteers

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin E

Interventions

Vitamin E DIETARY_SUPPLEMENT

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

Arsenic exposed controls; Arsenicosis patients; Heathy volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

Location

MeSH Terms

Interventions

Vitamin E

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. and Chairman

Study Record Dates

• First Submitted: December 1, 2012
• First Posted: December 6, 2012
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

BA (1)