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

Tanta University

Status: Completed

Conditions: Beta Thalassemia Major

Treatments: Drug: Spirulina; Drug: Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT02671695

22/03/15

Details and patient eligibility

About

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

Full 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

Enrollment: 40 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Group 1

Experimental group

Description:

chelation therapy plus Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months

Treatment:

Drug: Spirulina

Group 2

Experimental group

Description:

chelation therapy plus Amlodipine in a dose of 5 mg/day orally for 3 months

Treatment:

Drug: Amlodipine