Clinical trial NCT02908581: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Arsenic Poisoning
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

Primary outcomes:
measure: Changes in the type of fungus in skin surface
timeFrame: [0 weeks (baseline), 12 weeks (end)] [Safety Issue: No]
Secondary outcomes:
measure: Scoring palmar arsenical keratosis
timeFrame: [0 weeks (baseline), 12 weeks (end)] [Safety Issue: No]
Other outcomes:
Locations:
city: Comilla
country: Bangladesh
facility: Laksham Upazilla Health Complex
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Mir Misbahuddin, PhD
role: STUDY_DIRECTOR
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Priyanka Moitra, MBBS
role: PRINCIPAL_INVESTIGATOR
References: