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

Primary Purpose

Chronic Arsenic Poisoning

Status
Completed
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Vitamin E capsule
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Arsenic Poisoning

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Muradnagar Health Complex

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Patients

Arsenic exposed controls

Healthy volunteers

Arm Description

Vitamin E capsule 200 IU bd x 12 weeks

Vitamin E capsule 200 IU bd x 12 weeks

Vitamin E capsule 200 IU bd x 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical improvement in palmar arsenical keratosis following supplementation
There will be improvement of moderate palmar arsenical keratosis following supplementation with vitamin E

Full Information

First Posted
January 27, 2015
Last Updated
January 12, 2016
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT02468518
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Arsenic Poisoning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Vitamin E capsule 200 IU bd x 12 weeks
Arm Title
Arsenic exposed controls
Arm Type
Active Comparator
Arm Description
Vitamin E capsule 200 IU bd x 12 weeks
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
Vitamin E capsule 200 IU bd x 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vitamin E capsule
Other Intervention Name(s)
E-Cap, Batch No. 461016
Intervention Description
Capsules will be distributed to each participant free of cost
Primary Outcome Measure Information:
Title
Identification of aerobic bacteria in five areas of the skin
Description
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
Time Frame
0 weeks (baseline), 12 weeks (end)
Secondary Outcome Measure Information:
Title
Clinical improvement in palmar arsenical keratosis following supplementation
Description
There will be improvement of moderate palmar arsenical keratosis following supplementation with vitamin E
Time Frame
0 weeks (baseline), 12 weeks (end)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mir Misbahuddin
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Study Director
Facility Information:
Facility Name
Muradnagar Health Complex
City
Comilla
Country
Bangladesh

12. IPD Sharing Statement

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

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