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NCT Number: NCT02908581

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Laksham Upazilla Health Complex

Comilla, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

Treatment and study plan

Placebo

Drug

Administered orally once daily

Other names: Tablet placebo

Iron 150 mg and Folic acid 0.5 mg

Drug

Iron will be administered with folic acid orally

Other names: Tab Ferrous sulfate and Tablet Folic acid

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2016
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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