Vitamin E Level in Buccal Cells of Arsenicosis Patients

Not Applicable

Completed

• Conditions: Chronic Arsenic Poisoning
• Interventions: Dietary Supplement: Vitamin E

• Registration Number: NCT01743066
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

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 Timeline

• Study Start: 2010-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-12
• Study First Submitted: 2012-12-01
• Study First Submitted QC: 2012-12-04
• Last Update Submitted: 2012-12-04
• Study First Posted: 2012-12-06
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arsenicosis patients	Vitamin E	Vitamin E (200 IU, caplet) daily orally for 20 weeks
Arsenic exposed controls	Vitamin E	vitamin E (200 IU, caplet) daily orally for 20 weeks
Heathy volunteers	Vitamin E	Vitamin E (200 IU, caplet) daily orally for 20 weeks

Primary Outcome Measures

Name	Time	Method
Change in the amount of vitamin E in buccal cells	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 Outcome Measures

Name	Time	Method
Changes in the amount of cholesterol in buccal cells	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.
Changes in the concentration of vitamin E in serum	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.
Changes in the concentration of cholesterol in serum	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.

Trial Locations

Locations (1)

Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University; 🇧🇩 Dhaka, Bangladesh