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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier:
NCT01752972
First received: December 17, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Arsenical Keratosis
Dietary Supplement: Spirulina

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

Resource links provided by NLM:


Further study details as provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:

Primary Outcome Measures:
  • Change in vitamin E levels in skin palm extract following supplementation with spirulina [ Time Frame: 0 week (baseline), 12 weeks (end) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in zinc levels in skin palm extract following supplementation with spirulina [ Time Frame: 0 week (baseline), 12 weeks (end) ] [ Designated as safety issue: No ]
  • Change in linoleic acid levels in skin palm extract following supplementation with spirulina [ Time Frame: 0 week (baseline), 12 weeks (end) ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palmer arsenical keratosis
Spirulina 10 g/day orally for 12 weeks
Dietary Supplement: Spirulina
10 g/day orally for 12 weeks
Active Comparator: Arsenic exposed controls
Spirulina 10 g/day orally for 12 weeks
Dietary Supplement: Spirulina
10 g/day orally for 12 weeks
Active Comparator: Heathy volunteers
Spirulina 10 g/day orally for 12 weeks
Dietary Supplement: Spirulina
10 g/day orally for 12 weeks

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

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752972

Locations
Bangladesh
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
Principal Investigator: Mir Misbahuddin, MBBS, PhD Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  More Information

No publications provided

Responsible Party: Prof. Mir Misbahuddin, Prof. and Chairman, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT01752972     History of Changes
Other Study ID Numbers: BSMMU-006-CT
Study First Received: December 17, 2012
Last Updated: December 17, 2012
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
Arsenic
Keratosis
Linoleic acid
Palm
Spirulina
Vitamin E
Zinc

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 14, 2014