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

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.

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).

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.

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 pHafter a month (P = 0.013 and P = 0.003, respectively). The two groups had no significant differences regarding serum phosphate reduction (P = 0.391).

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.