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

January 12, 2016 updated by: Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Comilla, Bangladesh
        • Muradnagar Health Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of aerobic bacteria in five areas of the skin
Time Frame: 0 weeks (baseline), 12 weeks (end)
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
Time Frame: 0 weeks (baseline), 12 weeks (end)
There will be improvement of moderate palmar arsenical keratosis following supplementation with vitamin E
0 weeks (baseline), 12 weeks (end)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

  • Study Director: Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 11, 2015

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSMMU-007-CT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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