Clinical trial NCT01752972: Effect of Spirulina on Zinc, Vitamin E and Linoleic Acid Levels in Palm Skin Following Chronic Exposure to Arsenic
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arsenical Keratosis
Keywords: Arsenic
Keratosis
Linoleic acid
Palm
Spirulina
Vitamin E
Zinc
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

Eligibility 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

Primary outcomes:
measure: Change in vitamin E levels in skin palm extract following supplementation with spirulina
timeFrame: 0 week (baseline), 12 weeks (end)
Secondary outcomes:
measure: Change in zinc levels in skin palm extract following supplementation with spirulina
timeFrame: 0 week (baseline), 12 weeks (end)
measure: Change in linoleic acid levels in skin palm extract following supplementation with spirulina
timeFrame: 0 week (baseline), 12 weeks (end)
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bangabandhu Sheikh Mujib Medical University
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Mir Misbahuddin, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: