Beta Thalassemia MajorNCT02674607
the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children
A study testing Spirulina in people with Beta Thalassemia Major, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the possible immunologic effects of spirulina in children with beta thalassemia. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Beta Thalassemia Major
- 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
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to Oct 2017
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- children with thalassemia major
Who cannot join
- children with other chronic hemolytic anemias
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine- Tanta University
Tanta, Gharbia Governorate, 0000
About this study
The aim of this study is to evaluate the possible immunologic effects of spirulina in children with beta thalassemia.
- Conditions
- Beta Thalassemia Major
- Being tested
- Spirulina
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirulinaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | thirty children with beta thalassemia major will receive oral spirulina (tablets=500 mg) for 3 months with a dose of 250 mg/kg/day (maximum dose 4 gm) Receives: Dietary Supplement: Spirulina |
| controls | No intervention | thirty healthy children of matched age and sex |
What is being measured
The primary outcome is the main question the study is designed to answer.
cluster of differentiation (CD4/CD25) ratio
Measured: 3 months
cluster of differentiation (CD33/CD11b/Lin) ratio
Measured: 3 months
serum immunoglobulins levels
Measured: 3 months
serum levels of interferon gamma
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta Thalassemia MajorStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Mohamed Elshanshory, Tanta University
- Investigators
- Mohamed R El-Shanshory, MD, Principal investigator, professor of pediatrics- head of hematooncology unit of pediatric department- Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674607
- Sponsor's protocol ID
- 2132/10/13
- Status last verified
- Oct 2017
- First submitted
- 1 Feb 2016
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children
- ClinicalTrials.gov ID
- NCT02674607
- Acronym / sponsor ID
- 2132/10/13
- Conditions
- Beta Thalassemia Major
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 4 Feb 2016 (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.
The aim of this study is to evaluate the possible immunologic effects of spirulina in children with beta thalassemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Dietary Supplement: Spirulinathirty children with beta thalassemia major will receive oral spirulina (tablets=500 mg) for 3 months with a dose of 250 mg/kg/day (maximum dose 4 gm) |
| controls | No intervention | –thirty healthy children of matched age and sex |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children with thalassemia major
Key exclusion criteria (1 listed)
- children with other chronic hemolytic anemias
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 |
|---|---|---|
| Spirulina | Dietary supplement | patients |
Primary outcome
cluster of differentiation (CD4/CD25) ratio
Time frame: 3 months
cluster of differentiation (CD33/CD11b/Lin) ratio
Time frame: 3 months
serum immunoglobulins levels
Time frame: 3 months
serum levels of interferon gamma
Time frame: 3 months
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 25 Oct 2017.
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Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
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Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
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A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
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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.
Mohamed R El-Shanshory, MD principal investigator
professor of pediatrics- head of hematooncology unit of pediatric department- Tanta University
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 Beta Thalassemia Major, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 1 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 25 Oct 2017. 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 Egypt. 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?
cluster of differentiation (CD4/CD25) ratio (time frame: 3 months). The study lists 4 primary outcomes in all. 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 25 Oct 2017.