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

NCT ID: NCT01752972

Last Updated: 2012-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Arsenical Keratosis

Keywords

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Arsenic Keratosis Linoleic acid Palm Spirulina Vitamin E Zinc

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Palmer arsenical keratosis

Spirulina 10 g/day orally for 12 weeks

Group Type EXPERIMENTAL

Spirulina

Intervention Type DIETARY_SUPPLEMENT

10 g/day orally for 12 weeks

Arsenic exposed controls

Spirulina 10 g/day orally for 12 weeks

Group Type ACTIVE_COMPARATOR

Spirulina

Intervention Type DIETARY_SUPPLEMENT

10 g/day orally for 12 weeks

Heathy volunteers

Spirulina 10 g/day orally for 12 weeks

Group Type ACTIVE_COMPARATOR

Spirulina

Intervention Type DIETARY_SUPPLEMENT

10 g/day orally for 12 weeks

Interventions

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Spirulina

10 g/day orally for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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


* 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


* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Prof. Mir Misbahuddin

Prof. and Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mir Misbahuddin, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

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Bangabandhu Sheikh Mujib Medical University

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

Other Identifiers

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BSMMU-006-CT

Identifier Type: -

Identifier Source: org_study_id