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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01752972
Other study ID # BSMMU-006-CT
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT03127670 - Effect of Solanum Melongena Extract in the Treatment of Arsenical Skin Lesion Phase 2
Completed NCT01735097 - Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis N/A
Completed NCT01731756 - Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis N/A
Completed NCT01442727 - Selenium in the Treatment of Arsenic Toxicity and Cancers Phase 3