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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Completed; Phase 2

Conditions: Chronic Arsenic Poisoning

Treatments: Drug: Vitamin E capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT02468518

BSMMU-007-CT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Patients

Experimental group

Description:

Vitamin E capsule 200 IU bd x 12 weeks

Treatment:

Drug: Vitamin E capsule

Arsenic exposed controls

Active Comparator group

Description:

Vitamin E capsule 200 IU bd x 12 weeks

Treatment:

Drug: Vitamin E capsule

Healthy volunteers

Active Comparator group

Description:

Vitamin E capsule 200 IU bd x 12 weeks

Treatment:

Drug: Vitamin E capsule