Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia

Tanta University40 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Beta Thalassemia Major

Interventions

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

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, Egypt

Outcomes

Primary Outcomes

cardiac iron concentration by magnetic resonance imaging

Time frame: 3 months

Secondary Outcomes

cardiac troponin 1

Time frame: 3 months

N-terminal pro-brain natriuretic peptide

Time frame: 3 months

Data from ClinicalTrials.gov

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