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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01743066
Other study ID # BSMMU-004-CT
Secondary ID
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


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
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Completed NCT01726426 - Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics N/A