Chronic Arsenic PoisoningNCT01743066
Vitamin E Level in Buccal Cells of Arsenicosis Patients
A study testing Vitamin E in people with Chronic Arsenic Poisoning, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Arsenic Poisoning
- What is being tested?
- Vitamin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- Oct 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- tuberculosis, eczema psoriasis, contact dermatitis
- patients getting treatment of arsenicosis
- subject who voluntarily do not agree to participate
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University
Dhaka
About this study
Official title: Vitamin E Level in Buccal Cells of Arsenicosis Patients Following Vitamin E Supplementation
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.
Read the 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.
- Conditions
- Chronic Arsenic Poisoning
- Being tested
- Vitamin E
- Keywords
- Arsenic, Arsenicosis, Buccal cells, Serum, Vitamin E, Cholesterol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDietary supplement
vitamin E (200 IU, caplet) daily orally for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arsenicosis patients | Experimental | Vitamin E (200 IU, caplet) daily orally for 20 weeks Receives: Dietary Supplement: Vitamin E |
| Arsenic exposed controls | Active comparator | vitamin E (200 IU, caplet) daily orally for 20 weeks Receives: Dietary Supplement: Vitamin E |
| Heathy volunteers | Active comparator | Vitamin E (200 IU, caplet) daily orally for 20 weeks Receives: Dietary Supplement: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 week (baseline), 20 weeks (end)
Secondary outcomes (3)
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.
Measured: 0 week (baseline), 20 weeks (end)
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.
Measured: 0 week (baseline), 20 weeks (end)
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.
Measured: 0 week (baseline), 20 weeks (end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Arsenic PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743066
- Sponsor's protocol ID
- BSMMU-004-CT
- Status last verified
- Dec 2012
- First submitted
- 1 Dec 2012
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin E Level in Buccal Cells of Arsenicosis Patients Following Vitamin E Supplementation
- ClinicalTrials.gov ID
- NCT01743066
- Acronym / sponsor ID
- BSMMU-004-CT
- Conditions
- Chronic Arsenic Poisoning
- Keywords
- Arsenic, Arsenicosis, Buccal cells, Serum, Vitamin E, Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arsenicosis patients | Experimental | Dietary Supplement: Vitamin EVitamin E (200 IU, caplet) daily orally for 20 weeks |
| Arsenic exposed controls | Active comparator | Dietary Supplement: Vitamin Evitamin E (200 IU, caplet) daily orally for 20 weeks |
| Heathy volunteers | Active comparator | Dietary Supplement: Vitamin EVitamin E (200 IU, caplet) daily orally for 20 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- tuberculosis, eczema psoriasis, contact dermatitis
- patients getting treatment of arsenicosis
- subject who voluntarily do not agree to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin Evitamin E (200 IU, caplet) daily orally for 20 weeks | Dietary supplement | Arsenic exposed controls, Arsenicosis patients, Heathy volunteers |
Primary outcome
Change in the amount of vitamin E in buccal cells
Time frame: 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.
3 secondary outcomes
Changes in the amount of cholesterol in buccal cells
Time frame: 0 week (baseline), 20 weeks (end)
Changes in the concentration of vitamin E in serum
Time frame: 0 week (baseline), 20 weeks (end)
Changes in the concentration of cholesterol in serum
Time frame: 0 week (baseline), 20 weeks (end)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin E in people with Chronic Arsenic Poisoning, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the amount of vitamin E in buccal cells (time frame: 0 week (baseline), 20 weeks (end)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.