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

Not Applicable

Completed

• Conditions: Beta Thalassemia Major
• Interventions: Drug: Amlodipine; Drug: Spirulina

• Registration Number: NCT02671695
• Lead Sponsor: Tanta University

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-01-30
• Study First Submitted QC: 2016-01-30
• Study First Posted: 2016-02-02
• Status Verified: 2017-10
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Amlodipine	chelation therapy plus Amlodipine in a dose of 5 mg/day orally for 3 months
Group 1	Spirulina	chelation therapy plus Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months

Primary Outcome Measures

Name	Time	Method
cardiac iron concentration by magnetic resonance imaging	3 months

Secondary Outcome Measures

Name	Time	Method
cardiac troponin 1	3 months
N-terminal pro-brain natriuretic peptide	3 months

Trial Locations

Locations (1)

Faculty of Medicine- Tanta University; 🇪🇬 Tanta, Gharbia, Egypt