Efficacy of Vitamin E on Renal Function and Preventing Proximal Tubulopathy Caused by Iron Chelation Therapy in Thalassemia Major Patients: A Randomized Controlled Clinical Trial

Abstract

Background: Acute kidney injury and proximal tubulopathy, resulting from Deferasirox administration, contribute significantly to acquired kidney failure. The role of antioxidants in preventing acute kidney injury remains inconclusive. Objectives: This study aimed to investigate the efficacy of vitamin E in preventing acute kidney injury and proximal tubulopathy in thalassemia major patients undergoing treatment with Deferasirox (Nanojade). Methods: This study employed a randomized controlled trial conducted at the thalassemia center of Amirkabir Hospital in Arak, Iran. Sixty patients with thalassemia major receiving Nanojade at 20 mg/kg were included. The vitamin E group (n = 30) received a daily dose of 400 IU for a month, while the control group (n = 30) did not receive any vitamin E. The primary outcome measure was Acute Kidney Injury (AKI), defined as a greater than 50% increase in serum creatinine levels after seven days of Deferasirox administration. Additionally, proximal tubulopathy was assessed using serum phosphate (P), Venous Blood Gas (VBG), and urinalysis (U/A) after one month. Also, the Glomerular Filtration Rate (GFR) and blood urea nitrogen to creatinine ratio (BUN/Cr) were compared between the two groups. Results: No AKI or proximal tubulopathy occurrences were observed in either group, thus limiting the investigation into the preventive effect of vitamin E in these conditions. However, several noteworthy findings emerged from our analysis. Regarding GFR and blood urea nitrogen to creatinine ratio (BUN/Cr), there was no significant difference between the vitamin E and control groups after one month (P = 0.985 and P = 0.063, respectively). The increase in serum creatinine levels during the first week was significantly lower in the vitamin E group than in the control group (P = 0.019). However, there was no difference after one month (P = 0.984). Notably, the vitamin E group exhibited a significantly lower decrease in serum bicarbonate (HCO3) and pH after a month (P = 0.013 and P = 0.003, respectively). The two groups had no significant differences regarding serum phosphate reduction (P = 0.391). Conclusions: Administering vitamin E for one week effectively prevents an increase in serum creatinine levels and prevents the decrease of Deferasirox-induced PH and HCO3 in thalassemia patients. However, it does not significantly affect the GFR.