Oxidative stress markers and tissue iron overload after 12-months vitamin E supplementation for children with transfusion-dependent β-thalassemia on different iron chelators: A randomized placebo-controlled trial

Background: Vitamin E is an anti-oxidant depleted in thalassemia as a result of iron overload. Aim: We investigated the efficacy and safety of vitamin E as an adjuvant therapy to iron chelators in transfusion-dependent thalassemia patients in relation to tissue iron overload and examine its potential corrective value to oxidative stress markers including peroxiredoxin-2 (PRDX2). Methods: This randomized prospective study included 180 pediatric patients with transfusiondependent beta-thalassemia who were equally divided into three groups to either receive desferrioxamine (DFO), deferiprone (DFP) or deferasirox (DFX). Patients in each group were further randomized to receive vitamin E supplementation (400 mg daily) or matching placebo. Patients were followed-up for 12 months with assessment of oxidative stress markers (malondialdehyde [MDA], reduced glutathione, superoxide dismutase, glutathione peroxidase and PRDX2), serum ferritin (SF), liver iron content (LIC) and cardiac T2* by magnetic resonance imaging. The primary endpoint was the change between groups from baseline to 12 months as regards LIC. Results: After vitamin E therapy, transfusion index, SF and LIC were significantly decreased while hemoglobin and cardiac T2* were elevated compared with baseline levels or placebo group. MDA levels were decreased while the studied antioxidants were improved after vitamin E supplementation compared with baseline levels or placebo. DFX-treated patients had the highest hemoglobin level with the lowest SF, LIC and MDA levels compared with DFO or DFP subgroups. Conclusions: Vitamin E is a safe adjuvant anti-oxidant therapy that potentiates the efficacy of DFX in reducing iron burden in transfusion-dependent beta-thalassemia patients. This trial was registered under ClinicalTrials.gov Identifier no. NCT06509581. (c) 2025 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights are reserved, including those for text and data mining, AI training, and similar technologies.