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NCT02671695 Clinical Trial

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

Beta Thalassemia Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02671695
Other study ID # 22/03/15
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date April 2018

Study information
Verified date October 2017
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group 8 Years to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Spirulina
Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months
• Amlodipine
Amlodipine in a dose of 5 mg/day orally for 3 months

Locations
Country Name City State
Egypt Faculty of Medicine- Tanta University Tanta Gharbia

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary cardiac iron concentration by magnetic resonance imaging 3 months
Secondary cardiac troponin 1 3 months
Secondary N-terminal pro-brain natriuretic peptide 3 months
See also
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Completed NCT02674607 - the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children N/A
Terminated NCT01571635 - Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta( β)- Thalassemia. Phase 2
Completed NCT04092205 - Phase 2a Pilot Study of NBMI Treatment in Patients With Beta Thalassemia Major, Requiring Iron Chelation Phase 2
Completed NCT02744560 - Effect of Spirulina on Liver Iron Concentration in Beta Thalassemic Children With Hepatitis C N/A
Recruiting NCT04353986 - PK of SOF/LED in HCV - Infected Adolescents With Haematological Disorders Phase 3
Not yet recruiting NCT02173951 - An Algorithm to Start Iron Chelation in Minimally Transfused Young Beta-thalassemia Major Patients Phase 2/Phase 3
Completed NCT03947632 - Anthropometric Measurements in Children Having Transfusion-dependent Beta Thalassemia
Withdrawn NCT04776850 - Pre-transplant Immunosuppression and Donor Stem Cell Transplant for the Treatment of Severe Hemoglobinopathies Early Phase 1
Completed NCT02744105 - Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C N/A
Completed NCT02744547 - Effect of Spirulina on Serum Hyaluronic Acid in Beta Thalassemic Children With Hepatitis C N/A
Active, not recruiting NCT03101423 - Monitoring of Chimerism After Transplantation in Patients With β Thalassemia Major and the Treatment Strategies for the Reduction of Chimerism N/A
Completed NCT00658385 - Assess the Feasibility and Safety of Granulocyte Colony Stimulating Factor (GCSF) Mobilization of CD34+ Hematopoietic Progenitor Cells in Patients With Betathalassemia Major N/A