Beta ThalassemiaNCT02597595
Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major
A study testing spirulina in people with Beta Thalassemia, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the cardioprotective effect 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
- 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
- Nov 2014to 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 suffering from beta thalassemia major with age range from 4-18 years
Who cannot join
- children with congenital heart diseases children with rheumatic heart diseases presence of heart failure children with coronary arterial disease children with cardiomyopathy
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 cardioprotective effect of spirulina in children with beta thalassemia.
Read the detailed description
The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia.
this study will be carried on thirty children with beta thalassemia major from those attending the Hematology Unit of Pediatric department at Tanta University Hospital, and another thirty healthy children of matched age and sex will be enrolled as controls.
all studied children will be subjected to careful history taking and through clinical examination. laboratory investigations will be done including complete blood count, hemoglobin electrophoresis, serum ferritin, liver and kidney functions, and troponin-1 plasma level. echocardiographic assessment of the cardiac functions will be done for all patients. Source data will be the patients medical records.
oral spirulina will be given for studied patients for 3 months, and clinical examination, laboratory investigations and cardiac functions will be assessed at the time of inclusion in the study, and again after 3 months of regular spirulina supplementation.
An informed consent will be obtained from parents of all included subjects. the results of this study will be tabulated and statistically analyzed using Statistical Package for the Social Sciences (SPSS).
- Conditions
- Beta Thalassemia
- 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.
spirulinaOther
oral spirulina (tablet=500mg) will be given to patients for 3 months in a dose of 250 mg/kg/day (maximum 4 gm)
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | thirty children with beta thalassemia major, with age range from 4-18 years, will receive oral spirulina (tablets=500 mg) for 3 months with a dose of 250 mg/kg/day (maximum dose 4 gm) Receives: Other: 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.
cardiac functions measured by echocardiography
Fractional shortening [FS]. Mitral flow early phase filling velocity [E], peak atrial phase filling velocity[A] and E/A ratio, and left ventricular (LV) diastolic function
Measured: after 3 months of regular oral spirulina supplementation
Secondary outcomes (1)
cardiac functions measured by troponin-1 plasma level.
Measured: after 3 months of regular oral spirulina supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startNov 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Beta ThalassemiaStudies 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
- Single blind
- Who is masked
- Care provider
- 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
- Magda M Ibrahim, M.B.B.ch, Principal investigator, Master Degree studentOsama AR Tolba, MD, Study chair, supervisorRasha M Gamal, MD, Study director, supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597595
- Sponsor's protocol ID
- 2771/09/14
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2015
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khan M, Shobha JC, Mohan IK, Naidu MU, Sundaram C, Singh S, Kuppusamy P, Kutala VK. Protective effect of Spirulina against doxorubicin-induced cardiotoxicity. Phytother Res. 2005 Dec;19(12):1030-7. doi: 10.1002/ptr.1783.
PubMed 16372368Cogliandro T, Derchi G, Mancuso L, Mayer MC, Pannone B, Pepe A, Pili M, Bina P, Cianciulli P, De Sanctis V, Maggio A; Society for the Study of Thalassemia and Hemoglobinopathies (SoSTE). Guideline recommendations for heart complications in thalassemia major. J Cardiovasc Med (Hagerstown). 2008 May;9(5):515-25. doi: 10.2459/JCM.0b013e3282f20847.
PubMed 18404006Pennell DJ, Udelson JE, Arai AE, Bozkurt B, Cohen AR, Galanello R, Hoffman TM, Kiernan MS, Lerakis S, Piga A, Porter JB, Walker JM, Wood J; American Heart Association Committee on Heart Failure and Transplantation of the Council on Clinical Cardiology and Council on Cardiovascular Radiology and Imaging. Cardiovascular function and treatment in beta-thalassemia major: a consensus statement from the American Heart Association. Circulation. 2013 Jul 16;128(3):281-308. doi: 10.1161/CIR.0b013e31829b2be6. Epub 2013 Jun 17.
PubMed 23775258
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major
- ClinicalTrials.gov ID
- NCT02597595
- Acronym / sponsor ID
- 2771/09/14
- Conditions
- Beta Thalassemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 5 Nov 2015 (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 cardioprotective effect of spirulina in children with beta thalassemia.
Detailed description
The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia.
this study will be carried on thirty children with beta thalassemia major from those attending the Hematology Unit of Pediatric department at Tanta University Hospital, and another thirty healthy children of matched age and sex will be enrolled as controls.
all studied children will be subjected to careful history taking and through clinical examination. laboratory investigations will be done including complete blood count, hemoglobin electrophoresis, serum ferritin, liver and kidney functions, and troponin-1 plasma level. echocardiographic assessment of the cardiac functions will be done for all patients. Source data will be the patients medical records.
oral spirulina will be given for studied patients for 3 months, and clinical examination, laboratory investigations and cardiac functions will be assessed at the time of inclusion in the study, and again after 3 months of regular spirulina supplementation.
An informed consent will be obtained from parents of all included subjects. the results of this study will be tabulated and statistically analyzed using Statistical Package for the Social Sciences (SPSS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Other: spirulinathirty children with beta thalassemia major, with age range from 4-18 years, 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 suffering from beta thalassemia major with age range from 4-18 years
Key exclusion criteria (1 listed)
- children with congenital heart diseases children with rheumatic heart diseases presence of heart failure children with coronary arterial disease children with cardiomyopathy
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 |
|---|---|---|
| spirulinaoral spirulina (tablet=500mg) will be given to patients for 3 months in a dose of 250 mg/kg/day (maximum 4 gm) | Other | patients |
Primary outcome
cardiac functions measured by echocardiography
Time frame: after 3 months of regular oral spirulina supplementation
Fractional shortening [FS]. Mitral flow early phase filling velocity [E], peak atrial phase filling velocity[A] and E/A ratio, and left ventricular (LV) diastolic function
1 secondary outcome
cardiac functions measured by troponin-1 plasma level.
Time frame: after 3 months of regular oral spirulina supplementation
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 11 Sep 2018.
- Background: PubMed 16372368Khan M, Shobha JC, Mohan IK, Naidu MU, Sundaram C, Singh S, Kuppusamy P, Kutala VK. Protective effect of Spirulina against doxorubicin-induced cardiotoxicity. Phytother Res. 2005 Dec;19(12):1030-7. doi: 10.1002/ptr.1783.
- Background: PubMed 18404006Cogliandro T, Derchi G, Mancuso L, Mayer MC, Pannone B, Pepe A, Pili M, Bina P, Cianciulli P, De Sanctis V, Maggio A; Society for the Study of Thalassemia and Hemoglobinopathies (SoSTE). Guideline recommendations for heart complications in thalassemia major. J Cardiovasc Med (Hagerstown). 2008 May;9(5):515-25. doi: 10.2459/JCM.0b013e3282f20847.
- Background: PubMed 23775258Pennell DJ, Udelson JE, Arai AE, Bozkurt B, Cohen AR, Galanello R, Hoffman TM, Kiernan MS, Lerakis S, Piga A, Porter JB, Walker JM, Wood J; American Heart Association Committee on Heart Failure and Transplantation of the Council on Clinical Cardiology and Council on Cardiovascular Radiology and Imaging. Cardiovascular function and treatment in beta-thalassemia major: a consensus statement from the American Heart Association. Circulation. 2013 Jul 16;128(3):281-308. doi: 10.1161/CIR.0b013e31829b2be6. Epub 2013 Jun 17.
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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.
Magda M Ibrahim, M.B.B.ch principal investigator
Master Degree student
Osama AR Tolba, MD study chair
supervisor
Rasha M Gamal, MD study director
supervisor
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, 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 11 Sep 2018. 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?
cardiac functions measured by echocardiography (time frame: after 3 months of regular oral spirulina supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597595, which also lists 3 linked publications.
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 11 Sep 2018.