Back to resultsEffect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
Primary Purpose
Beta Thalassemia Major
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Spirulina
Amlodipine
Sponsored by
About this trial
This is an interventional treatment trial for Beta Thalassemia Major
Eligibility 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
Sites / Locations
- Faculty of Medicine- Tanta University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
chelation therapy plus Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months
chelation therapy plus Amlodipine in a dose of 5 mg/day orally for 3 months
Outcomes
Primary Outcome Measures
cardiac iron concentration by magnetic resonance imaging
Secondary Outcome Measures
cardiac troponin 1
N-terminal pro-brain natriuretic peptide
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02671695
Brief Title
Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
Official Title
Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Beta Thalassemia Major
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
chelation therapy plus Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months
Arm Title
Group 2
Arm Type
Experimental
Arm Description
chelation therapy plus Amlodipine in a dose of 5 mg/day orally for 3 months
Intervention Type
Drug
Intervention Name(s)
Spirulina
Intervention Description
Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
Amlodipine in a dose of 5 mg/day orally for 3 months
Primary Outcome Measure Information:
Title
cardiac iron concentration by magnetic resonance imaging
Time Frame
3 months
Secondary Outcome Measure Information:
Title
cardiac troponin 1
Time Frame
3 months
Title
N-terminal pro-brain natriuretic peptide
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar M El-Haggar, MD
Organizational Affiliation
assisstant professor of clinical pharmacy- Faculty of Pharmacy- Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine- Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
0000
Country
Egypt
12. IPD Sharing Statement
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Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
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