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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 January 2016 |
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Main ID: |
NCT02468518 |
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Date of registration:
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27/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Vitamin E on Skin Aerobic Bacteria in Palmar Arsenical Keratosis
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Scientific title:
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Randomized, Open Label Trial of Vitamin E on Change of Aerobic Bacterial Pattern |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02468518 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Mir Misbahuddin |
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Address:
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Telephone:
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Email:
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Affiliation:
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BSMMU |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Arsenic Poisoning
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Intervention(s)
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Drug: Vitamin E capsule
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Primary Outcome(s)
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Identification of aerobic bacteria in five areas of the skin
[Time Frame: 0 weeks (baseline), 12 weeks (end)]
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Secondary Outcome(s)
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Clinical improvement in palmar arsenical keratosis following supplementation
[Time Frame: 0 weeks (baseline), 12 weeks (end)]
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Secondary ID(s)
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BSMMU-007-CT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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