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

Arsenical Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752972
• Other study ID #: BSMMU-006-CT
• Status: Completed
• Phase: N/A
• First received: December 17, 2012
• Last updated: December 17, 2012
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arsenical Keratosis
• Keratosis

Intervention

Dietary Supplement:
• Spirulina
10 g/day orally for 12 weeks

Locations

Country	Name	City	State
Bangladesh	Bangabandhu Sheikh Mujib Medical University	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vitamin E levels in skin palm extract following supplementation with spirulina		0 week (baseline), 12 weeks (end)	No
Secondary	Change in zinc levels in skin palm extract following supplementation with spirulina		0 week (baseline), 12 weeks (end)	No
Secondary	Change in linoleic acid levels in skin palm extract following supplementation with spirulina		0 week (baseline), 12 weeks (end)	No