Effect of Iron and Folic Acid on Skin Fungal Pattern in Patients With Arsenicosis

Chronic Arsenic Poisoning Clinical Trial

Official title:

Randomized, Open Label Trial of Iron and Folic Acid on Change of Fungal Pattern

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908581
• Other study ID #: BSMMU-010-CT
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2016
• Last updated: July 11, 2017
• Start date: June 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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:

Related Conditions & MeSH terms

• Arsenic Poisoning
• Chronic Arsenic Poisoning
• Poisoning

Intervention

Drug:
• Placebo
Administered orally once daily
• Iron 150 mg and Folic acid 0.5 mg
Iron will be administered with folic acid orally

Locations

Country	Name	City	State
Bangladesh	Laksham Upazilla Health Complex	Comilla

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	[0 weeks (baseline), 12 weeks (end)] [Safety Issue: No]
Secondary	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	[0 weeks (baseline), 12 weeks (end)] [Safety Issue: No]