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

Not Applicable

Completed

• Conditions: Arsenical Keratosis
• Interventions: Dietary Supplement: Spirulina

• Registration Number: NCT01752972
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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).

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-12
• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-17
• Last Update Submitted: 2012-12-17
• Study First Posted: 2012-12-19
• Last Update Posted: 2012-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

• pregnancy
• lactation
• chronic diseases: diabetes mellitus, rheumatoid arthritis, tuberculosis
• arsenicosis patients under treatment in the previous 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palmer arsenical keratosis	Spirulina	Spirulina 10 g/day orally for 12 weeks
Arsenic exposed controls	Spirulina	Spirulina 10 g/day orally for 12 weeks
Heathy volunteers	Spirulina	Spirulina 10 g/day orally for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in vitamin E levels in skin palm extract following supplementation with spirulina	0 week (baseline), 12 weeks (end)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Bangabandhu Sheikh Mujib Medical University; 🇧🇩 Dhaka, Bangladesh