Effect of Spirulina on Zinc, Vitamin E and Linoleic Acid Levels in Palm Skin Following Chronic Exposure to Arsenic
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 17, 2012
CompletedFirst Posted
Study publicly available on registry
December 19, 2012
CompletedDecember 19, 2012
December 1, 2012
8 months
December 17, 2012
December 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in vitamin E levels in skin palm extract following supplementation with spirulina
0 week (baseline), 12 weeks (end)
Secondary Outcomes (2)
Change in zinc levels in skin palm extract following supplementation with spirulina
0 week (baseline), 12 weeks (end)
Change in linoleic acid levels in skin palm extract following supplementation with spirulina
0 week (baseline), 12 weeks (end)
Study Arms (3)
Palmer arsenical keratosis
EXPERIMENTALSpirulina 10 g/day orally for 12 weeks
Arsenic exposed controls
ACTIVE COMPARATORSpirulina 10 g/day orally for 12 weeks
Heathy volunteers
ACTIVE COMPARATORSpirulina 10 g/day orally for 12 weeks
Interventions
10 g/day orally for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnancy
- lactation
- chronic diseases: diabetes mellitus, rheumatoid arthritis, tuberculosis
- arsenicosis patients under treatment in the previous 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mir Misbahuddin, MBBS, PhD
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. and Chairman
Study Record Dates
First Submitted
December 17, 2012
First Posted
December 19, 2012
Study Start
April 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
December 19, 2012
Record last verified: 2012-12