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Completed

NCT Number: NCT01752972

Effect of Spirulina on Zinc, Vitamin E and Linoleic Acid Levels in Palm Skin Following Chronic Exposure to Arsenic

Patients of arsenical keratosis may be treated with spirulina. Is this improvement related to the levels of zinc, vitamin E and linoleic acid at the site of the keratosis (palm)? To understand this, patients of palmer arsenical keratosis (n=10), arsenic exposed controls (n=10) and healthy volunteers (n=10) will be treated with spirulina powder 10 g/day orally for 12 weeks. Skin extracts will be collected both before and after supplementation from the palm and dorsum for estimation of zinc, vitamin E and linoleic acid levels.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

About this study

Patients of arsenical keratosis remain untreated due to unavailability of effective drug. To find out an effective drug, the pathogenesis of keratosis should be understood. Spirulina is one of the dietary supplements, that improves the symptoms of keratosis. Is this improvement related to the levels of zinc, vitamin E and linoleic acid at the site of the keratosis (palm)? Ten patients of moderate palmer arsenical keratosis will be treated with spirulina powder 10 g/day orally for 12 weeks. Skin extracts will be collected both before and after supplementation from the palm and dorsum using a mixture of chloroform and ethanol. Zinc, vitamin E and linoleic acid levels will be estimated from the extracts. Similar protocol of spirulina administration and the collection of skin extracts will be done in arsenic exposed controls (n=10) and healthy volunteers (n=10).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

(Patients):

  • moderate palmer keratosis
  • drink arsenic contaminated water (>50 µg/L) for at least 6 months
  • voluntarily agree to participate

Inclusion criteria

(Arsenic exposed controls):

  • no symptoms of keratosis
  • family member of the patient
  • drink arsenic contaminated water (>50 µg/L) for at least 6 months
  • voluntarily agree to participate

Inclusion criteria

(Healthy volunteers):

  • no symptoms of keratosis
  • drink arsenic safe water (<50 µg/L)
  • voluntarily agree to participate

Exclusion criteria

  • pregnancy
  • lactation
  • chronic diseases: diabetes mellitus, rheumatoid arthritis, tuberculosis
  • arsenicosis patients under treatment in the previous 3 months

Treatment and study plan

Spirulina

Dietary Supplement

10 g/day orally for 12 weeks

Primary outcomes

  1. Change in vitamin E levels in skin palm extract following supplementation with spirulina

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

Secondary outcomes

  1. Change in zinc levels in skin palm extract following supplementation with spirulina

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

  2. Change in linoleic acid levels in skin palm extract following supplementation with spirulina

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

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

Effect of Spirulina on the Levels of Zinc, Vitamin E and Linoleic Acid in the Palm Skin Extracts of People With Prolonged Exposure to Arsenic

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 19, 2012
Registry last updated
Dec 19, 2012

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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