Effect of Spirulina on Zinc, Vitamin E and Linoleic Acid... | NCT01752972

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

NCT01752972

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status

Completed

Last Update Posted

Dec 19, 2012Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Arsenical Keratosis

Interventions

Spirulina

Countries

Bangladesh

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Dec 17, 2012

First Submission Date that Met QC Criteria

Dec 17, 2012

First Posted Date

Dec 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2012

Last Update Posted Date

Dec 19, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Mir Misbahuddin, Prof. and Chairman, Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPrincipal Investigator

Lead Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Palmer arsenical keratosis	Experimental	Spirulina 10 g/day orally for 12 weeks	Dietary Supplement: Spirulina
Arsenic exposed controls	Active Comparator	Spirulina 10 g/day orally for 12 weeks	Dietary Supplement: Spirulina
Heathy volunteers	Active Comparator	Spirulina 10 g/day orally for 12 weeks	Dietary Supplement: Spirulina

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spirulina	Dietary Supplement	10 g/day orally for 12 weeks	Arsenic exposed controls Heathy volunteers Palmer arsenical keratosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in vitamin E levels in skin palm extract following supplementation with spirulina		0 week (baseline), 12 weeks (end)

Secondary Outcomes

Measure	Description	Time Frame
Change in zinc levels in skin palm extract following supplementation with spirulina		0 week (baseline), 12 weeks (end)
Change in linoleic acid levels in skin palm extract following supplementation with spirulina		0 week (baseline), 12 weeks (end)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mir Misbahuddin, MBBS, PhD	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bangabandhu Sheikh Mujib Medical University		Dhaka			Bangladesh

Condition Browse Module

MeSH Terms

ID	Term
D007642	Keratosis

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

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