Clinical trial NCT02468518: Effect of Vitamin E on Skin Aerobic Bacteria in Palmar Arsenical Keratosis
Official title: Randomized, Open Label Trial of Vitamin E on Change of Aerobic Bacterial Pattern
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Arsenic Poisoning
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Identification of aerobic bacteria in five areas of the skin
timeFrame: 0 weeks (baseline), 12 weeks (end)
Secondary outcomes:
measure: Clinical improvement in palmar arsenical keratosis following supplementation
timeFrame: 0 weeks (baseline), 12 weeks (end)
Other outcomes:
Locations:
city: Comilla
country: Bangladesh
facility: Muradnagar Health Complex
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Mir Misbahuddin
role: STUDY_DIRECTOR
References: