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

Primary Purpose

Arsenical Keratosis

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Spirulina
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arsenical Keratosis focused on measuring Arsenic, Keratosis, Linoleic acid, Palm, Spirulina, Vitamin E, Zinc

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bangabandhu Sheikh Mujib Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Palmer arsenical keratosis

Arsenic exposed controls

Heathy volunteers

Arm Description

Spirulina 10 g/day orally for 12 weeks

Spirulina 10 g/day orally for 12 weeks

Spirulina 10 g/day orally for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2012
Last Updated
December 17, 2012
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT01752972
Brief Title
Effect of Spirulina on Zinc, Vitamin E and Linoleic Acid Levels in Palm Skin Following Chronic Exposure to Arsenic
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arsenical Keratosis
Keywords
Arsenic, Keratosis, Linoleic acid, Palm, Spirulina, Vitamin E, Zinc

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palmer arsenical keratosis
Arm Type
Experimental
Arm Description
Spirulina 10 g/day orally for 12 weeks
Arm Title
Arsenic exposed controls
Arm Type
Active Comparator
Arm Description
Spirulina 10 g/day orally for 12 weeks
Arm Title
Heathy volunteers
Arm Type
Active Comparator
Arm Description
Spirulina 10 g/day orally for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Spirulina
Intervention Description
10 g/day orally for 12 weeks
Primary Outcome Measure Information:
Title
Change in vitamin E levels in skin palm extract following supplementation with spirulina
Time Frame
0 week (baseline), 12 weeks (end)
Secondary Outcome Measure Information:
Title
Change in zinc levels in skin palm extract following supplementation with spirulina
Time Frame
0 week (baseline), 12 weeks (end)
Title
Change in linoleic acid levels in skin palm extract following supplementation with spirulina
Time Frame
0 week (baseline), 12 weeks (end)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mir Misbahuddin, MBBS, PhD
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bangabandhu Sheikh Mujib Medical University
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Learn more about this trial

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

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