Beta Thalassemia MajorNCT02671695
Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
A study testing Spirulina and Amlodipine 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 effect of Spirulina compared to Amlodipine on cardiac iron overload and cardiac functions in multi-transfused children with beta thalassemia major Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Beta Thalassemia Major
- What is being tested?
- Spirulina and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2015to Apr 2018
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients on regular blood transfusions.
- iron overload with no perspective of changing the chelation therapy in the following three months
Who cannot join
- formal contraindication to magnetic resonance examinations
- implantable cardiac device
- advanced cardiomyopathy or conduction block
- other types of 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 effect of Spirulina compared to Amlodipine on cardiac iron overload and cardiac functions in multi-transfused children with beta thalassemia major
Read the detailed description
the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on cardiac iron overload using magnetic resonance imaging and cardiac functions in multi-transfused children with beta thalassemia major
- Conditions
- Beta Thalassemia Major
- Being tested
- Spirulina, Amlodipine
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirulinaDrug
Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months
AmlodipineDrug
Amlodipine in a dose of 5 mg/day orally for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | chelation therapy plus Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months Receives: Drug: Spirulina |
| Group 2 | Experimental | chelation therapy plus Amlodipine in a dose of 5 mg/day orally for 3 months Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac iron concentration by magnetic resonance imaging
Measured: 3 months
Secondary outcomes (2)
cardiac troponin 1
Measured: 3 months
N-terminal pro-brain natriuretic peptide
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 posted2 Feb 2016 (estimated)
- Study startApr 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 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
- Sahar M El-Haggar, MD, Principal investigator, assisstant professor of clinical pharmacy- Faculty of Pharmacy- Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671695
- Sponsor's protocol ID
- 22/03/15
- Status last verified
- Oct 2017
- First submitted
- 30 Jan 2016
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Padhani ZA, Gangwani MK, Sadaf A, Hasan B, Colan S, Alvi N, Das JK. Calcium channel blockers for preventing cardiomyopathy due to iron overload in people with transfusion-dependent beta thalassaemia. Cochrane Database Syst Rev. 2023 Nov 17;11(11):CD011626. doi: 10.1002/14651858.CD011626.pub3.
PubMed 37975597
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
- ClinicalTrials.gov ID
- NCT02671695
- Acronym / sponsor ID
- 22/03/15
- Conditions
- Beta Thalassemia Major
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 2 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 effect of Spirulina compared to Amlodipine on cardiac iron overload and cardiac functions in multi-transfused children with beta thalassemia major
Detailed description
the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on cardiac iron overload using magnetic resonance imaging and cardiac functions in multi-transfused children with beta thalassemia major
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Spirulinachelation therapy plus Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months |
| Group 2 | Experimental | Drug: Amlodipinechelation therapy plus Amlodipine in a dose of 5 mg/day orally for 3 months |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients on regular blood transfusions.
- iron overload with no perspective of changing the chelation therapy in the following three months
Key exclusion criteria (4 listed)
- formal contraindication to magnetic resonance examinations
- implantable cardiac device
- advanced cardiomyopathy or conduction block
- other types of 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 |
|---|---|---|
| SpirulinaSpirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months | Drug | Group 1 |
| AmlodipineAmlodipine in a dose of 5 mg/day orally for 3 months | Drug | Group 2 |
Primary outcome
cardiac iron concentration by magnetic resonance imaging
Time frame: 3 months
2 secondary outcomes
cardiac troponin 1
Time frame: 3 months
N-terminal pro-brain natriuretic peptide
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 12 Jul 2018.
- Derived from this study: PubMed 37975597Padhani ZA, Gangwani MK, Sadaf A, Hasan B, Colan S, Alvi N, Das JK. Calcium channel blockers for preventing cardiomyopathy due to iron overload in people with transfusion-dependent beta thalassaemia. Cochrane Database Syst Rev. 2023 Nov 17;11(11):CD011626. doi: 10.1002/14651858.CD011626.pub3.
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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.
Sahar M El-Haggar, MD principal investigator
assisstant professor of clinical pharmacy- Faculty of Pharmacy- 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 and Amlodipine 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 2 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 12 Jul 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 iron concentration by magnetic resonance imaging (time frame: 3 months). 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 NCT02671695, which also lists 1 linked publication.
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 12 Jul 2018.