Effect of Iron and Folic Acid on Skin Fungal Pattern in Patients With Arsenicosis
Primary Purpose
Chronic Arsenic Poisoning
Status
Completed
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Placebo
Iron 150 mg and Folic acid 0.5 mg
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Arsenic Poisoning
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
Exclusion Criteria:
- Pregnant and lactating mother
- Any other chronic diseases like tuberculosis, diabetes mellitus, asthma
- Patient under treatment of arsenicosis on Criteria:
Sites / Locations
- Laksham Upazilla Health Complex
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Placebo
Iron 150 mg and Folic acid 0.5 mg
Arm Description
21 Patients Placebo Each tablet by mouth once daily for 12 weeks
21 Patients Iron 150 mg and Folic acid 0.5 mg Each tablet by mouth once daily for 12 weeks
Outcomes
Primary Outcome Measures
Changes in the type of fungus in skin surface
Skin swab from five areas of skin (palm, dorsum of the hands, front, back of the chest and axilla) will be taken to see the changes in the type of fungus in skin surface in 12 weeks
Secondary Outcome Measures
Scoring palmar arsenical keratosis
Palmar arsenical keratosis will be scored at 0 week and 12 weeks. The change in the score after 12 weeks following supplementation with folic acid will be examined
Full Information
NCT ID
NCT02908581
First Posted
August 28, 2016
Last Updated
July 11, 2017
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT02908581
Brief Title
Effect of Iron and Folic Acid on Skin Fungal Pattern in Patients With Arsenicosis
Official Title
Randomized, Open Label Trial of Iron and Folic Acid on Change of Fungal Pattern
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
July 2017 (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 fungal pattern on skin of arsenicosis patients before and after administration of iron (150 mg) and folic acid (0.5 mg) tablets.
Detailed Description
Arsenicosis is remaining as a precarious issue in Bangladesh for the last few decades. The fact of resentment is that this perilous condition still remains unresolved worldwide. So, it has become the demand of era to address this issue. Different diseases are manifested in different way. In arsenicosis melanosis and keratosis are the most common manifestations. The actual mechanism of development of keratosis is unclear. Chronic ingestion of arsenic contaminated water causes accumulation of arsenic in keratin rich tissues like skin, hair, nail and producing characteristic skin manifestations like melanosis and keratosis. Metabolism of arsenic depends on folate pathway and dietary deficiency of folic acid reduced the total arsenic excretion and leads to development of cancer. In different study results shown that folic acid reduces the blood arsenic level. As arsenicosis is a chronic disease condition, fungal infection is more common to them. Moreover the skin fungal pattern in arsenicosis yet not known. Therefore, this study will be conducted to determine is there any change in skin fungal pattern in patients with palmar arsenical keratosis before and after administration of iron and folic acid. Forty two patients with palmar arsenical keratosis will be recruited on the basis of inclusion and exclusion criteria. Twenty one patients will be furnished tablet placebo once daily for 12 weeks without any interruption. Another twenty one patients will be furnished iron (150 mg) and folic acid (0.5 mg) once daily for 12 weeks without any interruption. Water and nail samples will be collected for confirming the diagnosis. Skin sample will be collected two times (before and after giving iron and folic acid) for qualitative analysis of fungi. So, this study will determine any change in fungal pattern after administrating tablet iron and folic acid.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
21 Patients Placebo Each tablet by mouth once daily for 12 weeks
Arm Title
Iron 150 mg and Folic acid 0.5 mg
Arm Type
Experimental
Arm Description
21 Patients Iron 150 mg and Folic acid 0.5 mg Each tablet by mouth once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Tablet placebo
Intervention Description
Administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Iron 150 mg and Folic acid 0.5 mg
Other Intervention Name(s)
Tab Ferrous sulfate and Tablet Folic acid
Intervention Description
Iron will be administered with folic acid orally
Primary Outcome Measure Information:
Title
Changes in the type of fungus in skin surface
Description
Skin swab from five areas of skin (palm, dorsum of the hands, front, back of the chest and axilla) will be taken to see the changes in the type of fungus in skin surface in 12 weeks
Time Frame
[0 weeks (baseline), 12 weeks (end)] [Safety Issue: No]
Secondary Outcome Measure Information:
Title
Scoring palmar arsenical keratosis
Description
Palmar arsenical keratosis will be scored at 0 week and 12 weeks. The change in the score after 12 weeks following supplementation with folic acid will be examined
Time Frame
[0 weeks (baseline), 12 weeks (end)] [Safety Issue: No]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Exclusion Criteria:
Pregnant and lactating mother
Any other chronic diseases like tuberculosis, diabetes mellitus, asthma
Patient under treatment of arsenicosis on Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mir Misbahuddin, PhD
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Priyanka Moitra, MBBS
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laksham Upazilla Health Complex
City
Comilla
Country
Bangladesh
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Iron and Folic Acid on Skin Fungal Pattern in Patients With Arsenicosis
We'll reach out to this number within 24 hrs