Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- cardiac iron concentration by magnetic resonance imaging
Study Overview
Brief 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
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients on regular blood transfusions.
- •iron overload with no perspective of changing the chelation therapy in the following three months
Exclusion Criteria
- •formal contraindication to magnetic resonance examinations
- •implantable cardiac device
- •advanced cardiomyopathy or conduction block
- •other types of hemolytic anemias
Arms & Interventions
Group 1
chelation therapy plus Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months
Intervention: Spirulina (Drug)
Group 2
chelation therapy plus Amlodipine in a dose of 5 mg/day orally for 3 months
Intervention: Amlodipine (Drug)
Outcomes
Primary Outcomes
cardiac iron concentration by magnetic resonance imaging
Time Frame: 3 months
Secondary Outcomes
- cardiac troponin 1(3 months)
- N-terminal pro-brain natriuretic peptide(3 months)
Investigators
Professor Mohamed Elshanshory
head of pediatric hematology and oncology unit
Tanta University