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
20 Years
40 Years
Both
Arsenical Keratosis
Trial Information
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 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).
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Change in vitamin E levels in skin palm extract following supplementation with spirulina
Outcome Time Frame:
0 week (baseline), 12 weeks (end)
Safety Issue:
No
Principal Investigator
Mir Misbahuddin, MBBS, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Authority:
Bangladesh: Ethical Review Committee
Study ID:
BSMMU-006-CT
NCT ID:
NCT01752972
Start Date:
April 2011
Completion Date:
December 2011
Related Keywords:
- Arsenical Keratosis
- Arsenic
- Keratosis
- Linoleic acid
- Palm
- Spirulina
- Vitamin E
- Zinc
- Keratosis
- Keratosis, Actinic
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