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

Study Overview
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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).

Official Title
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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

Conditions
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Arsenical Keratosis

Intervention / Treatment
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* Dietary Supplement: Spirulina


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palmer arsenical keratosis<br>Spirulina 10 g/day orally for 12 weeks | Dietary Supplement: Spirulina<br>* 10 g/day orally for 12 weeks<br>|
| Active Comparator: Arsenic exposed controls<br>Spirulina 10 g/day orally for 12 weeks | Dietary Supplement: Spirulina<br>* 10 g/day orally for 12 weeks<br>|
| Active Comparator: Heathy volunteers<br>Spirulina 10 g/day orally for 12 weeks | Dietary Supplement: Spirulina<br>* 10 g/day orally for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arsenic, Keratosis, Linoleic acid, Palm, Spirulina, Vitamin E, Zinc