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

NCT02908581 | Completed Phase 2

• 1 other identifier: BSMMU-010-CT
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Arsenic Poisoning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Scoring palmar arsenical keratosis

  [0 weeks (baseline), 12 weeks (end)] [Safety Issue: No]

Study Arms (2)

Placebo

ACTIVE COMPARATOR

21 Patients Placebo Each tablet by mouth once daily for 12 weeks

Drug: Placebo

Iron 150 mg and Folic acid 0.5 mg

EXPERIMENTAL

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

Interventions

Placebo DRUG

Administered orally once daily

Also known as: Tablet placebo

Placebo

Iron 150 mg and Folic acid 0.5 mg DRUG

Iron will be administered with folic acid orally

Also known as: Tab Ferrous sulfate and Tablet Folic acid

Iron 150 mg and Folic acid 0.5 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnant and lactating mother
• Any other chronic diseases like tuberculosis, diabetes mellitus, asthma
• Patient under treatment of arsenicosis on Criteria:

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Laksham Upazilla Health Complex

Comilla, Bangladesh

Location

MeSH Terms

Interventions

Iron; Folic Acid; ferrous sulfate

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mir Misbahuddin, PhD

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  STUDY DIRECTOR

• Priyanka Moitra, MBBS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2016
• First Posted: September 21, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 13, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)