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

Chronic Arsenic Poisoning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468518
• Other study ID #: BSMMU-007-CT
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2015
• Last updated: January 12, 2016
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arsenic Poisoning
• Chronic Arsenic Poisoning

Intervention

Drug:
• Vitamin E capsule
Capsules will be distributed to each participant free of cost

Locations

Country	Name	City	State
Bangladesh	Muradnagar Health Complex	Comilla

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No