Abstract
Background & aimIron overload in thalassemia major (TM) leads to excessive iron deposition in a wide variety of tissues especially the heart leading to iron-overload cardiomyopathy, which is the major determinant of survival in those patients. Our goal was to study effects of Amlodipine and Spirulina on iron loading when added to chelation therapy in patients with TM. MethodForty patients with TM undergoing chelation therapy were randomized into two groups (1:1); group 1 received Amlodipine 5 mg/day, and group 2 received Spirulina 250 mg/kg/day for 3 months. Patients were assessed for MRI examination (cardiac T2*) and laboratory data including ferritin, troponin I, and NT-proBNP levels at baseline and after 3 months. ResultsAfter 3 months, cardiac T2* increased significantly from 21.8 ± 7.7 ms to 22.94 ± 7.1 ms (p = 0.03) in Spirulina group, and from 21.9 ± 8.7 ms to 24.6 ± 9.4 ms (p = 0.007) in Amlodipine group. There was significant reduction in ferritin levels in Spirulina group (p = 0.007), but not in Amlodipine group (p = 0.09). In addition, NT-proBNP level decreased significantly in both groups. There was no statistically significant difference between both groups concerning cardiac T2*, serum ferritin, troponin I, and NT-proBNP levels at 3 months. ConclusionOur findings suggest that the use of Amlodipine or Spirulina as a complementary treatment with standard chelation therapy could reduce iron overload in patients with TM.This trial was registered at www.ClinicalTrials.gov as #NCT02671695.
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