NCT02468518

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Vitamin E capsule	Capsules will be distributed to each participant free of cost

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2015-06-11
• Last updated: 2016-01-13

Locations

1 site across 1 country: Bangladesh