Clinical Trial: Effect of Folic Acid on Skin Fungal Pattern in Patients With Arsenicosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized, Open Label Trial of Folic Acid on Change of Fungal Pattern

Brief Summary: This study will be conducted to observe any change in fungal pattern on skin of arsenicosis patients before and after administration of folic acid (5 mg) tablets.

Detailed Summary: 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 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 folic acid (5 mg) and iron (200 mg) once daily for 12 weeks without any interruption. Another twenty one patients will be furnished iron (200 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 folic acid.
Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Current Primary Outcome: Changes in the type of fungus in skin surface [ Time Frame: [0 weeks (baseline), 12 weeks (end)] [Safety Issue: No] ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Scoring palmar arsenical keratosis [ Time Frame: [0 weeks (baseline), 12 weeks (end)] [Safety Issue: No] ]

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


Original Secondary Outcome: Same as current

Information By: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Dates:
Date Received: August 28, 2016
Date Started: June 2016
Date Completion: July 2017
Last Updated: September 17, 2016
Last Verified: September 2016