CompletedNot Applicable

Vitamin E Level in Buccal Cells of Arsenicosis Patients

Bangladesh60 participantsStarted 2010-10

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the amount of vitamin E in buccal cells

Timeframe: 0 week (baseline), 20 weeks (end)

Trial details

NCT IDNCT01743066

SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-06

View on ClinicalTrials.gov More Chronic Arsenic Poisoning trials