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

December 17, 2012 updated by: Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Palmer arsenical keratosis
Spirulina 10 g/day orally for 12 weeks
Dietary supplement: Spirulina
10 g/day orally for 12 weeks
ACTIVE_COMPARATOR: Arsenic exposed controls
Spirulina 10 g/day orally for 12 weeks
Dietary supplement: Spirulina
10 g/day orally for 12 weeks
ACTIVE_COMPARATOR: Heathy volunteers
Spirulina 10 g/day orally for 12 weeks
Dietary supplement: Spirulina
10 g/day orally for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in vitamin E levels in skin palm extract following supplementation with spirulina
Time Frame: 0 week (baseline), 12 weeks (end)
0 week (baseline), 12 weeks (end)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in zinc levels in skin palm extract following supplementation with spirulina
Time Frame: 0 week (baseline), 12 weeks (end)
0 week (baseline), 12 weeks (end)
Change in linoleic acid levels in skin palm extract following supplementation with spirulina
Time Frame: 0 week (baseline), 12 weeks (end)
0 week (baseline), 12 weeks (end)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

December 17, 2012

First Submitted That Met QC Criteria

December 17, 2012

First Posted (ESTIMATE)

December 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 19, 2012

Last Update Submitted That Met QC Criteria

December 17, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSMMU-006-CT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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