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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Arsenic Poisoning
• Intervention / Treatment: Drug: Placebo; Drug: Iron 150 mg and Folic acid 0.5 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bangladesh
  • Comilla, Bangladesh
    • Laksham Upazilla Health Complex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Placebo; 21 Patients Placebo Each tablet by mouth once daily for 12 weeks	Drug: Placebo; Administered orally once daily; Other Names: Tablet placebo
Experimental: Iron 150 mg and Folic acid 0.5 mg; 21 Patients Iron 150 mg and Folic acid 0.5 mg Each tablet by mouth once daily for 12 weeks	Drug: Iron 150 mg and Folic acid 0.5 mg; Iron will be administered with folic acid orally; Other Names: Tab Ferrous sulfate and Tablet Folic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Investigators: Principal Investigator: Priyanka Moitra, MBBS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 28, 2016
• First Submitted That Met QC Criteria: September 17, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Nervous System Diseases; Neurotoxicity Syndromes; Heavy Metal Poisoning, Nervous System; Poisoning; Arsenic Poisoning; Physiological Effects of Drugs; Micronutrients; Vitamins; Hematinics; Folic Acid; Vitamin B Complex
• Other Study ID Numbers: BSMMU-010-CT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No