Effect of Vitamin E on Skin Aerobic Bacteria in Palmar Arsenical Keratosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, Open Label Trial of Vitamin E on Change of Aerobic Bacterial Pattern

Conditions
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Chronic Arsenic Poisoning

Intervention / Treatment
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* Drug: Vitamin E capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Patients): 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 Inclusion Criteria (Arsenic exposed controls): Family members of the patient History of drinking arsenic contaminated water (>50 µg/L) Those voluntarily agree to participate No sign/symptoms of palmar keratosis Inclusion Criteria (Healthy volunteers): Drinking arsenic safe water (<50 µg/L) Those voluntarily agree to participate Exclusion Criteria: Pregnant and lactating mother Any other chronic disease like tuberculosis, diabetes, asthma Patients under treatment of arsenicosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Vitamin E capsule 200 IU bd x 12 weeks | Drug: Vitamin E capsule<br>* Capsules will be distributed to each participant free of cost<br>* Other names: E-Cap, Batch No. 461016;|
| Active Comparator: Arsenic exposed controls<br>Vitamin E capsule 200 IU bd x 12 weeks | Drug: Vitamin E capsule<br>* Capsules will be distributed to each participant free of cost<br>* Other names: E-Cap, Batch No. 461016;|
| Active Comparator: Healthy volunteers<br>Vitamin E capsule 200 IU bd x 12 weeks | Drug: Vitamin E capsule<br>* Capsules will be distributed to each participant free of cost<br>* Other names: E-Cap, Batch No. 461016;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 0 weeks (baseline), 12 weeks (end) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement in palmar arsenical keratosis following supplementation | There will be improvement of moderate palmar arsenical keratosis following supplementation with vitamin E | 0 weeks (baseline), 12 weeks (end) |