Investigating the Effect of High-Dose Vitamin D3 Administration on Inflammatory Biomarkers in Patients with Moderate to Severe Traumatic Brain Injury: A Randomized Clinical Trial.
Farnoosh Masbough, Mehran Kouchek, Mohsen Koosha, Sara Salarian, Mirmohammad Miri, Masoomeh Raoufi, Niloufar Taherpour, Saied Amniati, Mohammad Sistanizad
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引用次数: 0
Abstract
Background: Traumatic brain injury (TBI) is one of the most common neurological disorders worldwide. We aimed to investigate the efficacy of high-dose vitamin D3 on inflammatory biomarkers in patients with moderate to severe TBI.
Methods: Thirty-five moderate to severe TBI patients were randomly assigned to intervention and control groups. Patients in the intervention group received a single intramuscular (IM) dose of 300,000 IU vitamin D. The primary endpoints were interleukin levels (IL-1β and IL-6), and the secondary endpoints were changes in neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), Glasgow Coma scale (GCS), and Glasgow Outcome Scale-Extended (GOS-E) scores compared between intervention and control arms of the study. The linear Generalized Estimating Equations were used for trend analysis and evaluating the association of independent factors to each outcome.
Results: The results revealed a significant decrease in IL-1β levels (-2.71±3.02, in the intervention group: P=0.001 vs. -0.14±3.70, in the control group: P=0.876) and IL-6 (-88.05±148.45, in the intervention group: P=0.0001 vs. -35.54±175.79, in the control groupL P=0.325) 3 days after the intervention. The improvement in the GCS score (P=0.001), reduction in NLR (P=0.001) and PLR (P=0.002), and improvement in the GOS-E score (P=0.039) was found to be greater in the vitamin D3 arm of the study than the control group.
Conclusion: Administration of high-dose vitamin D3 in the acute phase of TBI could be effective in lowering the inflammatory markers and improving the level of consciousness and long-term performance outcomes.Trial Registration Number: IRCT20180522039777N2.
背景:创伤性脑损伤(TBI)是全球最常见的神经系统疾病之一。我们旨在研究大剂量维生素 D3 对中重度创伤性脑损伤患者炎症生物标志物的疗效:35名中重度创伤性脑损伤患者被随机分配到干预组和对照组。主要终点是白细胞介素水平(IL-1β和IL-6),次要终点是中性粒细胞与淋巴细胞比值(NLR)、血小板与淋巴细胞比值(PLR)、格拉斯哥昏迷量表(GCS)和格拉斯哥结果量表扩展版(GOS-E)评分的变化。采用线性广义估计方程进行趋势分析,并评估独立因素与各项结果的关联:结果显示,干预组的 IL-1β 水平明显下降(-2.71±3.02,P=0.001 vs. -2.71±3.02,P=0.001 vs. -2.71±3.02):P=0.001 vs. -0.14±3.70, in the control group:P=0.876)和 IL-6 水平(干预组为 -88.05±148.45,对照组为 -0.14±3.70,P=0.0001):P=0.0001;对照组-35.54±175.79,P=0.325)。研究发现,维生素 D3 组的 GCS 评分改善(P=0.001)、NLR 降低(P=0.001)和 PLR 降低(P=0.002)以及 GOS-E 评分改善(P=0.039)均高于对照组:试验注册号:IRCT20180522039777N2。
期刊介绍:
The Iranian Journal of Medical Sciences (IJMS) is an international quarterly biomedical publication, which is sponsored by Shiraz University of Medical Sciences. The IJMS intends to provide a scientific medium of communication for researchers throughout the globe. The journal welcomes original clinical articles as well as clinically oriented basic science research experiences on prevalent diseases in the region and analysis of various regional problems.