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Completed

NCT Number: NCT02468518

Effect of Vitamin E on Skin Aerobic Bacteria in Palmar Arsenical Keratosis

This study will be conducted to observe any change in aerobic bacterial pattern on the skin of arsenicosis patients before and after administration of vitamin E (200 IU) capsules.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Muradnagar Health Complex

Comilla, Bangladesh

About this study

Arsenicosis has emerged as one of the main and hazardous public health problem in Bangladesh. Melanosis and keratosis are the most common manifestations of arsenicosis. The exact mechanism of development of keratosis is not clear. With chronic ingestion of arsenic contaminated water the excretion of arsenic through skin increases and also the oxidative stress, which in turn cause cellular damage. These changes may influence the growth of normal bacteria and consistency of skin, which may be responsible for keratosis. In different study results shown that, vitamin E, a potential antioxidant that halts lipid peroxidation and maintains cell membrane integrity, also detoxified arsenic from the body. Normal skin bacteria mainly composed of Gram +ve bacteria. In arsenicosis, this pattern changes from Gram +ve bacteria to Gram -ve bacteria. Still now no study have been conducted to see, the effect of vitamin E on skin bacteria in arsenicosis, as skin bacteria changes. Therefore, this study will be conducted to observe any change in aerobic bacterial pattern on the skin of arsenicosis before and after administration of vitamin E capsules. Fifteen patients with skin manifestations, 15 arsenic exposed control, 15 healthy volunteers will be recruited on the basis of inclusion and exclusion criteria. They will be provide vitamin E capsules 200 IU twice daily for 12 weeks without any interruption. Water and nail samples will be collected for confirming the diagnosis. Skin samples will be collected two times (before and after giving vitamin E) for qualitative analysis of bacteria. All the patients, arsenic exposed controls and healthy subjects will be provided with same capsule in same dosage schedule. So, this study will find any change of skin bacteria pattern after administrating vitamin E capsule.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

(Arsenic exposed controls):

  • Family members of the patient
  • History of drinking arsenic contaminated water (>50 µg/L)
  • Those voluntarily agree to participate
  • No sign/symptoms of palmar keratosis

Inclusion criteria

(Healthy volunteers):

  • Drinking arsenic safe water (<50 µg/L)
  • Those voluntarily agree to participate

Exclusion criteria

  • Pregnant and lactating mother
  • Any other chronic disease like tuberculosis, diabetes, asthma
  • Patients under treatment of arsenicosis

Treatment and study plan

Vitamin E capsule

Drug

Capsules will be distributed to each participant free of cost

Other names: E-Cap, Batch No. 461016

Primary outcomes

  1. Identification of aerobic bacteria in five areas of the skin

    Time frame: 0 weeks (baseline), 12 weeks (end)

    Change in Number of aerobic bacteria in five areas (palm, dorsum of the hand, front of the chest, axilla and nare) of the skin of patients in comparison to arsenic exposed controls and healthy volunteers after 12 weeks of supplementation with vitamin E

Secondary outcomes

  1. Clinical improvement in palmar arsenical keratosis following supplementation

    Time frame: 0 weeks (baseline), 12 weeks (end)

    There will be improvement of moderate palmar arsenical keratosis following supplementation with vitamin E

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

Randomized, Open Label Trial of Vitamin E on Change of Aerobic Bacterial Pattern

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 11, 2015
Registry last updated
Jan 13, 2016

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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