Chronic Arsenic PoisoningPhase 2NCT02468518
Effect of Vitamin E on Skin Aerobic Bacteria in Palmar Arsenical Keratosis
A Phase 2 study testing Vitamin E capsule in people with Chronic Arsenic Poisoning, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
This study will be conducted to observe any change in aerobic bacterial pattern on the skin of arsenicosis patients before and after administration of vitamin E (200 IU) capsules. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Arsenic Poisoning
- What is being tested?
- Vitamin E capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBangladesh
- Study dates
- Mar 2015to Jan 2016
- Phase
- Phase 2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- History of drinking arsenic contaminated water (>50 µg/L) for more than 6 months
- Patients having moderate palmar keratosis
- Patients those voluntarily agree to participate
- Family members of the patient
- History of drinking arsenic contaminated water (>50 µg/L)
- Those voluntarily agree to participate
Show all 9Show fewer
- No sign/symptoms of palmar keratosis
- Drinking arsenic safe water (<50 µg/L)
- Those voluntarily agree to participate
Who cannot join
- Pregnant and lactating mother
- Any other chronic disease like tuberculosis, diabetes, asthma
- Patients under treatment of arsenicosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open Label Trial of Vitamin E on Change of Aerobic Bacterial Pattern
This study will be conducted to observe any change in aerobic bacterial pattern on the skin of arsenicosis patients before and after administration of vitamin E (200 IU) capsules.
Read the detailed description
Arsenicosis has emerged as one of the main and hazardous public health problem in Bangladesh. Melanosis and keratosis are the most common manifestations of arsenicosis. The exact mechanism of development of keratosis is not clear. With chronic ingestion of arsenic contaminated water the excretion of arsenic through skin increases and also the oxidative stress, which in turn cause cellular damage. These changes may influence the growth of normal bacteria and consistency of skin, which may be responsible for keratosis. In different study results shown that, vitamin E, a potential antioxidant that halts lipid peroxidation and maintains cell membrane integrity, also detoxified arsenic from the body. Normal skin bacteria mainly composed of Gram +ve bacteria. In arsenicosis, this pattern changes from Gram +ve bacteria to Gram -ve bacteria. Still now no study have been conducted to see, the effect of vitamin E on skin bacteria in arsenicosis, as skin bacteria changes. Therefore, this study will be conducted to observe any change in aerobic bacterial pattern on the skin of arsenicosis before and after administration of vitamin E capsules. Fifteen patients with skin manifestations, 15 arsenic exposed control, 15 healthy volunteers will be recruited on the basis of inclusion and exclusion criteria. They will be provide vitamin E capsules 200 IU twice daily for 12 weeks without any interruption. Water and nail samples will be collected for confirming the diagnosis. Skin samples will be collected two times (before and after giving vitamin E) for qualitative analysis of bacteria. All the patients, arsenic exposed controls and healthy subjects will be provided with same capsule in same dosage schedule. So, this study will find any change of skin bacteria pattern after administrating vitamin E capsule.
- Conditions
- Chronic Arsenic Poisoning
- Being tested
- Vitamin E capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin E capsuleDrug
Also called E-Cap, Batch No. 461016
Capsules will be distributed to each participant free of cost
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Vitamin E capsule 200 IU bd x 12 weeks Receives: Drug: Vitamin E capsule |
| Arsenic exposed controls | Active comparator | Vitamin E capsule 200 IU bd x 12 weeks Receives: Drug: Vitamin E capsule |
| Healthy volunteers | Active comparator | Vitamin E capsule 200 IU bd x 12 weeks Receives: Drug: Vitamin E capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of aerobic bacteria in five areas of the skin
Change in Number of aerobic bacteria in five areas (palm, dorsum of the hand, front of the chest, axilla and nare) of the skin of patients in comparison to arsenic exposed controls and healthy volunteers after 12 weeks of supplementation with vitamin E
Measured: 0 weeks (baseline), 12 weeks (end)
Secondary outcomes (1)
Clinical improvement in palmar arsenical keratosis following supplementation
There will be improvement of moderate palmar arsenical keratosis following supplementation with vitamin E
Measured: 0 weeks (baseline), 12 weeks (end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionJan 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 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
- Investigators
- Mir Misbahuddin, Study director, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468518
- Sponsor's protocol ID
- BSMMU-007-CT
- Status last verified
- Jan 2016
- First submitted
- 27 Jan 2015
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label Trial of Vitamin E on Change of Aerobic Bacterial Pattern
- ClinicalTrials.gov ID
- NCT02468518
- Acronym / sponsor ID
- BSMMU-007-CT
- Conditions
- Chronic Arsenic Poisoning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Jun 2015 (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.
This study will be conducted to observe any change in aerobic bacterial pattern on the skin of arsenicosis patients before and after administration of vitamin E (200 IU) capsules.
Detailed description
Arsenicosis has emerged as one of the main and hazardous public health problem in Bangladesh. Melanosis and keratosis are the most common manifestations of arsenicosis. The exact mechanism of development of keratosis is not clear. With chronic ingestion of arsenic contaminated water the excretion of arsenic through skin increases and also the oxidative stress, which in turn cause cellular damage. These changes may influence the growth of normal bacteria and consistency of skin, which may be responsible for keratosis. In different study results shown that, vitamin E, a potential antioxidant that halts lipid peroxidation and maintains cell membrane integrity, also detoxified arsenic from the body. Normal skin bacteria mainly composed of Gram +ve bacteria. In arsenicosis, this pattern changes from Gram +ve bacteria to Gram -ve bacteria. Still now no study have been conducted to see, the effect of vitamin E on skin bacteria in arsenicosis, as skin bacteria changes. Therefore, this study will be conducted to observe any change in aerobic bacterial pattern on the skin of arsenicosis before and after administration of vitamin E capsules. Fifteen patients with skin manifestations, 15 arsenic exposed control, 15 healthy volunteers will be recruited on the basis of inclusion and exclusion criteria. They will be provide vitamin E capsules 200 IU twice daily for 12 weeks without any interruption. Water and nail samples will be collected for confirming the diagnosis. Skin samples will be collected two times (before and after giving vitamin E) for qualitative analysis of bacteria. All the patients, arsenic exposed controls and healthy subjects will be provided with same capsule in same dosage schedule. So, this study will find any change of skin bacteria pattern after administrating vitamin E capsule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Drug: Vitamin E capsuleVitamin E capsule 200 IU bd x 12 weeks |
| Arsenic exposed controls | Active comparator | Drug: Vitamin E capsuleVitamin E capsule 200 IU bd x 12 weeks |
| Healthy volunteers | Active comparator | Drug: Vitamin E capsuleVitamin E capsule 200 IU bd x 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- History of drinking arsenic contaminated water (>50 µg/L) for more than 6 months
- Patients having moderate palmar keratosis
- Patients those voluntarily agree to participate
- Family members of the patient
- History of drinking arsenic contaminated water (>50 µg/L)
Key exclusion criteria (3 listed)
- Pregnant and lactating mother
- Any other chronic disease like tuberculosis, diabetes, asthma
- Patients under treatment of arsenicosis
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 E capsuleAlso: E-Cap, Batch No. 461016Capsules will be distributed to each participant free of cost | Drug | Arsenic exposed controls, Healthy volunteers, Patients |
Primary outcome
Identification of aerobic bacteria in five areas of the skin
Time frame: 0 weeks (baseline), 12 weeks (end)
Change in Number of aerobic bacteria in five areas (palm, dorsum of the hand, front of the chest, axilla and nare) of the skin of patients in comparison to arsenic exposed controls and healthy volunteers after 12 weeks of supplementation with vitamin E
1 secondary outcome
Clinical improvement in palmar arsenical keratosis following supplementation
Time frame: 0 weeks (baseline), 12 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 13 Jan 2016.
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.
Mir Misbahuddin study director
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin E capsule 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 9 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 13 Jan 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Identification of aerobic bacteria in five areas of the skin (time frame: 0 weeks (baseline), 12 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 13 Jan 2016.