Beta Thalassemia Major Clinical Trial
Official title:
Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
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 |
Verified date | October 2017 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine- Tanta University | Tanta | Gharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
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 |
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