Arsenical KeratosisNCT01752972
Effect of Spirulina on Zinc, Vitamin E and Linoleic Acid Levels in Palm Skin Following Chronic Exposure to Arsenic
A study testing Spirulina in people with Arsenical Keratosis, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Arsenical Keratosis
- What is being tested?
- Spirulina
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBangladesh
- Study dates
- Apr 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- moderate palmer keratosis
- drink arsenic contaminated water (>50 µg/L) for at least 6 months
- voluntarily agree to participate
- no symptoms of keratosis
- family member of the patient
- drink arsenic contaminated water (>50 µg/L) for at least 6 months
Show all 10Show fewer
- voluntarily agree to participate
- no symptoms of keratosis
- drink arsenic safe water (<50 µg/L)
- voluntarily agree to participate
Who cannot join
- pregnancy
- lactation
- chronic diseases: diabetes mellitus, rheumatoid arthritis, tuberculosis
- arsenicosis patients under treatment in the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Arsenical Keratosis
- Being tested
- Spirulina
- Keywords
- Arsenic, Keratosis, Linoleic acid, Palm, Spirulina, Vitamin E, Zinc
- Medical subject headings
- Keratosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirulinaDietary supplement
10 g/day orally for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Palmer arsenical keratosis | Experimental | Spirulina 10 g/day orally for 12 weeks Receives: Dietary Supplement: Spirulina |
| Arsenic exposed controls | Active comparator | Spirulina 10 g/day orally for 12 weeks Receives: Dietary Supplement: Spirulina |
| Heathy volunteers | Active comparator | Spirulina 10 g/day orally for 12 weeks Receives: Dietary Supplement: Spirulina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin E levels in skin palm extract following supplementation with spirulina
Measured: 0 week (baseline), 12 weeks (end)
Secondary outcomes (2)
Change in zinc levels in skin palm extract following supplementation with spirulina
Measured: 0 week (baseline), 12 weeks (end)
Change in linoleic acid levels in skin palm extract following supplementation with spirulina
Measured: 0 week (baseline), 12 weeks (end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arsenical KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Mir Misbahuddin, MBBS, PhD, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752972
- Sponsor's protocol ID
- BSMMU-006-CT
- Status last verified
- Dec 2012
- First submitted
- 17 Dec 2012
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01752972
- Acronym / sponsor ID
- BSMMU-006-CT
- Conditions
- Arsenical Keratosis
- Keywords
- Arsenic, Keratosis, Linoleic acid, Palm, Spirulina, Vitamin E, Zinc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Palmer arsenical keratosis | Experimental | Dietary Supplement: SpirulinaSpirulina 10 g/day orally for 12 weeks |
| Arsenic exposed controls | Active comparator | Dietary Supplement: SpirulinaSpirulina 10 g/day orally for 12 weeks |
| Heathy volunteers | Active comparator | Dietary Supplement: SpirulinaSpirulina 10 g/day orally for 12 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- moderate palmer keratosis
- drink arsenic contaminated water (>50 µg/L) for at least 6 months
- voluntarily agree to participate
- no symptoms of keratosis
- family member of the patient
Key exclusion criteria (4 listed)
- pregnancy
- lactation
- chronic diseases: diabetes mellitus, rheumatoid arthritis, tuberculosis
- arsenicosis patients under treatment in the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirulina10 g/day orally for 12 weeks | Dietary supplement | Arsenic exposed controls, Heathy volunteers, Palmer arsenical keratosis |
Primary outcome
Change in vitamin E levels in skin palm extract following supplementation with spirulina
Time frame: 0 week (baseline), 12 weeks (end)
2 secondary outcomes
Change in zinc levels in skin palm extract following supplementation with spirulina
Time frame: 0 week (baseline), 12 weeks (end)
Change in linoleic acid levels in skin palm extract following supplementation with spirulina
Time frame: 0 week (baseline), 12 weeks (end)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mir Misbahuddin, MBBS, PhD principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirulina in people with Arsenical Keratosis, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vitamin E levels in skin palm extract following supplementation with spirulina (time frame: 0 week (baseline), 12 weeks (end)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2012; AzTrials last refreshed its copy on 7 Nov 2026.