Possible Effect of Vitamin D Supplementation on Methotrexate Adverse Effects in Pediatric Patients with Acute Lymphoblastic Leukemia

Abstract

Background: the Primary medication used in acute lymphoblastic leukemia is methotrexate, and the problem with this treatment is that it is hazardous to cancer patients. The study aim was evaluation of vitamin D effect on methotrexate toxicity, including oral ulcerations, bone marrow, renal, and hepatic toxicity, besides inflammatory mediators; IL-6 and TNF-α role in this toxicity. Methods: Methotrexate was used to treat 58 patients with acute lymphoblastic leukemia in a clinical trial which was a double-blinded randomized study; (30 in Group A - no vitamin D for 2 weeks after methotrexate treatment) and (28 in Group B - patient received vitamin D3 drops for 2 weeks after methotrexate treatment). Results: Leukocytic count, Hemoglobin and platelet count were significantly lower in patients didn’t receive Vitamin D compared to patients received Vitamin D. Serum bilirubin, liver enzymes, urea, creatinine, IL-6 and TNF-α levels were significantly higher in patients didn’t receive vitamin D compared to the other group, while there is no significant change in levels of albumin and total proteins in both groups. 24 hours after 2nd cycle of methotrexate, the study group's methotrexate level significantly decreased, while it significantly elevated in the control group. Mild oral mucositis grade (I, II) showed a significant increase in the study group and a decrease in the control group, whereas severe oral mucositis grade (III, IV) showed a significant decrease in the study group and an increase in the control one. Conclusion: Medication with vitamin D may be a significant factor in reducing methotrexate toxicity.