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Trial record 20 of 45 for:    ARSENIC ACID

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

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ClinicalTrials.gov Identifier: NCT01752972
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):
Prof. Mir Misbahuddin, 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.

Condition or disease Intervention/treatment
Arsenical Keratosis Dietary Supplement: Spirulina

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arsenic Vitamin E
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change in vitamin E levels in skin palm extract following supplementation with spirulina [ Time Frame: 0 week (baseline), 12 weeks (end) ]

Secondary Outcome Measures :
  1. Change in zinc levels in skin palm extract following supplementation with spirulina [ Time Frame: 0 week (baseline), 12 weeks (end) ]
  2. Change in linoleic acid levels in skin palm extract following supplementation with spirulina [ Time Frame: 0 week (baseline), 12 weeks (end) ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012

Keywords provided by Prof. Mir Misbahuddin, 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
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents