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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status: Completed

Conditions: Arsenical Keratosis

Treatments: Dietary Supplement: Spirulina

Study type: Interventional

Funder types: Other

Identifiers

NCT01752972

BSMMU-006-CT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Palmer arsenical keratosis

Experimental group

Description:

Spirulina 10 g/day orally for 12 weeks

Treatment:

Dietary Supplement: Spirulina

Arsenic exposed controls

Active Comparator group

Description:

Spirulina 10 g/day orally for 12 weeks

Treatment:

Dietary Supplement: Spirulina

Heathy volunteers

Active Comparator group

Description:

Spirulina 10 g/day orally for 12 weeks

Treatment:

Dietary Supplement: Spirulina