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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671695
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Mohamed Elshanshory, Tanta University

Study Description
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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

Condition or disease Intervention/treatment Phase
Beta Thalassemia Major Drug: Spirulina Drug: Amlodipine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
Study Start Date : April 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Thalassemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
chelation therapy plus Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months
 Drug: Spirulina
Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months
Experimental: Group 2
chelation therapy plus Amlodipine in a dose of 5 mg/day orally for 3 months
 Drug: Amlodipine
Amlodipine in a dose of 5 mg/day orally for 3 months


Outcome Measures
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Primary Outcome Measures :
  1. cardiac iron concentration by magnetic resonance imaging [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. cardiac troponin 1 [ Time Frame: 3 months ]
  2. N-terminal pro-brain natriuretic peptide [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671695


Locations
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Egypt
Faculty of Medicine- Tanta University
Tanta, Gharbia, Egypt, 0000
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Sahar M El-Haggar, MD assisstant professor of clinical pharmacy- Faculty of Pharmacy- Tanta University
More Information
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Responsible Party: Professor Mohamed Elshanshory, head of pediatric hematology and oncology unit, Tanta University
ClinicalTrials.gov Identifier: NCT02671695    
Other Study ID Numbers: 22/03/15
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: October 2017
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
 Metabolic Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents