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Vitamin E Level in Buccal Cells of Arsenicosis Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01743066
Enrollment
60
Registered
2012-12-06
Start date
2010-10-31
Completion date
2011-06-30
Last updated
2012-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Arsenic Poisoning

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTVitamin E

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

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the amount of vitamin E in buccal cells0 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

MeasureTime frameDescription
Changes in the amount of cholesterol in buccal cells0 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 serum0 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 serum0 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.

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026