Vitamin E Level in Buccal Cells of Arsenicosis Patients

Chronic Arsenic Poisoning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743066
• Other study ID #: BSMMU-004-CT
• Status: Completed
• Phase: N/A
• First received: December 1, 2012
• Last updated: December 4, 2012
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2012
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arsenic Poisoning
• Chronic Arsenic Poisoning

Intervention

Dietary Supplement:
• Vitamin E
vitamin E (200 IU, caplet) daily orally for 20 weeks

Locations

Country	Name	City	State
Bangladesh	Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Changes in the amount of cholesterol in buccal cells	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)	No
Secondary	Changes in the concentration of vitamin E in serum	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)	No
Secondary	Changes in the concentration of cholesterol in serum	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)	No