Effect of High-dose Vitamin D on IL-1β Blood Level in Patients with Moderate Stroke: A Randomized Clinical Trial

Background: Vitamin D has neuroprotective and anti-inflammatory effects in stroke patients, but its effect on pro-inflammatory and inflammatory cytokines, especially IL-1, has been investigated in a few trials. Objectives: This study aimed to determine the effect of prescribing a high dose of vitamin D on the anti-inflammatory parameters, short-term and long-term prognosis of patients with ischemic stroke. Methods: This randomized clinical trial was performed on 42 patients randomly divided into two equal groups of 21 in Imam Hussein Hospital. The patients were allocated through block randomization methods to receive 300,000 units of vitamin D (intramuscularly) or not receive it as a control group. Age, gender, and clinical and laboratory information were recorded. The stroke severity was calculated according to the National Institute of Health Stroke Scale (NIHSS) at the beginning of hospitalization and upon hospital discharge. The 3-month prognosis of the patients was recorded according to the Barthel criteria three months after the stroke. Vitamin D3 levels were recorded before and after injection, while the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) were assessed on the first day and for 7 consecutive days after hospitalization. All statistical analyses were performed using STATA version 14. A P-value 0.05 was considered significant. Results: The mean age of the patients was 61.45 ± 4.74 years. There were 18 female (42.86%) and 24 male patients (57.14%). In the vitamin D group, the mean IL-1 decreased compared to before the intervention (-23.60 ± 103.83), but this decrease was not statistically significant (P = 0.070). In addition, the changes in IL-1 after the intervention were statistically different between the two groups (mean difference of -23.60 ± 103.83 in the vitamin D group vs. 15.96 ± 9.64 in the control group). The mean IL-6 decreased in both groups after the intervention compared to before, although these changes were not statistically significant (P 0.05). In the group receiving vitamin D compared to the control group, the mean NLR decreased by about 2 units, the PLR decreased by about 10 units, and the NIHSS score decreased by about one unit during the study. However, these changes were not statistically significant (P 0.05). Conclusions: A high dose of vitamin D can improve the NIHSS score and decrease IL-1 and IL-6, although these changes were not statistically significant. The mean NLR and PLR decreased after using high-dose vitamin D.