الفهرس 
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Abstract
Acute lymphoblastic leukemia (ALL) is a malignant transformation and proliferation of lymphoid progenitor cells in the bone marrow, blood, and extramedullary locations. The improvement made in the treatment of childhood ALL is one of current medicine’s real success stories.
Methotrexate is a main drug used in the treatment of acute lymphoblastic leukemia, and its toxicity is a major problem in cancer patients. Because there have been few studies on the role of vitamin D in the pathogenesis of this toxicity, we investigated the effect of vitamin D administration on methotrexate toxicity such as oral ulcerations, bone marrow toxicity, renal and hepatic toxicity, and the role of inflammatory mediators; TNF-α and IL-6.
The study was a double blinded randomized clinical trial that included 58 patients with acute lymphoblastic leukemia who were treated with methotrexate (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). Patients were given a detailed history, examination, and investigations, which included a complete blood count using the CELL-DYN Ruby System, a liver function test, a kidney function test using the Dimension Xpand and Dimension Rxmax Chemistry Analyzers, methotrexate blood monitoring using the VIVA-E system, and serum Vitamin D, TNF-, and Interleukin 6 measurements using enzyme-linked immunosorbent assay (ELISA) techniques.
In this regard, our study initially considered four levels for vitamin D concentrations: deficient (10 ng/mL), insufficient (10 - 30 ng/mL), sufficient (30 - 100 ng/mL), and potentially toxic (>100 ng/mL).
Our findings revealed that there was a significant decrease in serum vitamin D levels after 2 weeks in the control group treated with high dose methotrexate without vitamin D drops, but a significant increase in serum vitamin D levels after 2 weeks in the study group treated with high dose methotrexate and vitamin D drops.
Our study results showed that, in repeated measures, the levels of total leukocytic count, haemoglobin and platelet count were lower in the control group, but significantly higher in the study group over the study period; additionally, the mean neutrophil count was significantly lower in both groups, but there was no significant change in the mean monocyte count in either group over the study period.
Furthermore, our findings revealed that serum bilirubin, liver enzymes, urea and creatinine levels increased significantly in the control group but decreased significantly in the study group over the study period, while there is no significant change in levels of albumin and total proteins in both groups. Besides, the study group experienced a considerable decrease in concentration of serum IL-6 & TNF-α while the control group experienced a small decrease.
In addition, our study results demonstrated that there was a significant increase in the mean of methotrexate level after 24hr in the control group during the study period, while there was a significant decrease in the mean of methotrexate level after 24hr in the study group during the study period.
Added to that, our study results showed that, in terms of oral mucositis, mild oral mucositis grade (I, II) showed a significant increase in the study group and a decrease in the control group over the course of the study, whereas severe oral mucositis grade (III, IV) showed a significant decrease in the study group and an increase in the control group over the course of the study.
Finally, vitamin D supplementation benefits overall health; however, addressing severe vitamin D insufficiency remains essential.
Because methotrexate may cause a variety of side effects, some of which are potentially fatal, it is critical to recognize them when rescue measures are taken. To treat the side effects of methotrexate, we are suggesting providing vitamin D drops to patients with acute lymphoblastic leukemia who are receiving high doses of methotrexate under the supervision of oncologists.