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repeated transfusions are the mainstay of disease management in most patients with transfusion dependent beta thalassemia.iron overload predispose to oxidative stress and tissue injury.
oxidative stress play important role in pathogenesis of anemia in beta thalassemia.
vitamin E is often depleted in thalassemia patients.
oxidative stress status is very important in thalassemic patients and explains the different manifestations in thalassemic patients.
vitamin E is fat soluble vitamin shown to reduce the oxidative stress in thalassemia and to reduce lipid peroxidation of red cell membranes.
therefore, this study shows the safety of oral vitamin E as adjuvant therapy to three iron chelators : desferoxamine,deferiprone and deferasirox in moderately iron overloaded children and adolescents with transfusion dependent beta thalassemia and its relation to iron overload over one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta thalassemia patiens with oxidative stress and taking iron chelators receiving vitamin E | Experimental | Beta thalassemia patiens with oxidative stress and taking iron chelators(desferoxamine,deferiprone or deferasirox) receiving vitamin E in dose 400 mg daily for 12 months |
|
| Beta thalassemia patiens with oxidative stress and taking iron chelators receiving placebo | Placebo Comparator | B thalassemia patiens with oxidative stress and taking iron chelators(desferoxamine,deferiprone or deferasirox) receiving placebo for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin E | Dietary Supplement | Vitamin E will be taken for 12 months for beta thalassemia patiens on regular packed red blood cell transfusion and chelators(desferoxamine,deferiprone and deferasirox ) |
| Measure | Description | Time Frame |
|---|---|---|
| effect of vitamin E on Liver iron concentration (LIC) | measuring the LIC using MRI (magnetic resonance imaging) in mg/g | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| effect of vitamin E on antioxidants enzymes | measuring antioxidants enzymes
| 12 months |
| effect of vit E supplementation on SF | measuring serum ferritin(SF)in ng/ml |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Abbasia | 11517 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20712766 | Background | Fibach E, Rachmilewitz EA. The role of antioxidants and iron chelators in the treatment of oxidative stress in thalassemia. Ann N Y Acad Sci. 2010 Aug;1202:10-6. doi: 10.1111/j.1749-6632.2010.05577.x. | |
| 40424814 | Derived | ElLaboudy MA, Saber MM, Adly AA, Ismail EA, Ibrahim FA, Elalfy OM. Oxidative stress markers and tissue iron overload after 12-months vitamin E supplementation for children with transfusion-dependent beta-thalassemia on different iron chelators: A randomized placebo-controlled trial. Clin Nutr. 2025 Jul;50:154-163. doi: 10.1016/j.clnu.2025.05.003. Epub 2025 May 14. |
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| ID | Term |
|---|---|
| D017086 | beta-Thalassemia |
| ID | Term |
|---|---|
| D013789 | Thalassemia |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
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| ID | Term |
|---|---|
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| PLACEBO | Other | placebo will be taken for 12 months for beta thalassemia patiens on regular packed red blood cell transfusion and chelators(desferoxamine,deferiprone and deferasirox ) |
|
| 12 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |