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Completed

NCT Number: NCT02671695

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

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

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Key information

Conditions

Beta Thalassemia Major Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Thalassemia beta-Thalassemia

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, 0000, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirulina

Drug

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

Amlodipine

Drug

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

Primary outcomes

  1. cardiac iron concentration by magnetic resonance imaging

    Time frame: 3 months

Secondary outcomes

  1. cardiac troponin 1

    Time frame: 3 months

  2. N-terminal pro-brain natriuretic peptide

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 2, 2016
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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