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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468518
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

Condition or disease Intervention/treatment Phase
Chronic Arsenic Poisoning Drug: Vitamin E capsule Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open Label Trial of Vitamin E on Change of Aerobic Bacterial Pattern
Study Start Date : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016


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 Name: 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 Name: 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 Name: E-Cap, Batch No. 461016




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468518


Locations
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Bangladesh
Muradnagar Health Complex
Comilla, Bangladesh
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
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Study Director: Mir Misbahuddin BSMMU
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Responsible Party: Prof. Mir Misbahuddin, Prof. and Chairman, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT02468518    
Other Study ID Numbers: BSMMU-007-CT
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Arsenic Poisoning
Poisoning
Chemically-Induced Disorders
Heavy Metal Poisoning, Nervous System
Neurotoxicity Syndromes
Nervous System Diseases
Vitamin E
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents