Ghorbani Zeinab, Rafiee Pegah, Haghighi Samaneh, Razeghi Jahromi Soodeh, Djalali Mahmoud, Moradi-Tabriz Hedieh, Mahmoudi Maryam, Togha Mansoureh
Cardiovascular Diseases Research Center, Department of Cardiology, Heshmat Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.
Department of Community Medicine, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.
J Pharm Health Care Sci. 2021 Mar 3;7(1):9. doi: 10.1186/s40780-021-00192-0.
Although the exact mechanism involved in migraine pathogenesis remained uncertain, and different researches have been developed to address the role of neuroinflammation and immune dysfunction. Therefore, considering the immune protective functions of vitamin D3, we aimed to investigate the effects of daily administration of 2000 IU D3 supplements on serum status of immune markers in migraine patients.
Eighty episodic migraineurs who randomly assigned into two equal groups to receive either vitamin D3 2000 IU/d or placebo for 12-week were enrolled in this placebo-controlled double-blind trial included. Serum concentrations of transforming growth factor-beta (TGF-β) and interleukin (IL)-17 were evaluated at baseline and after the trial via the ELISA method.
Applying ANCOVA adjusted for baseline levels and confounding variables, it was found that the serum level of TGF-β was significantly higher in vitamin D group (adjusted mean:1665.50 ng/L) than the placebo group (1361.90 ng/L) after the experiment (P-value = 0.012); on the other hand, vitamin D prevented the increment in IL-17 serum level in the intervention group after the trial (adjusted mean:37.84 ng/L) comparing to the controls (adjusted mean:70.09 ng/L; P-value = 0.039). The Pearson correlation analysis revealed a significant positive correlation between changes in serum 25-hydroxy-vitamin D (25(OH)D) and TGF-β (r = - 0.306, P-value = 0.008). In contrast, no significant correlations were noted between serum 25(OH) D and IL-17 changes throughout the study.
Based on the results of this study, it was revealed that 12-week vitamin D3 supplementation (2000 IU/day) could enhance the Th17/Treg related cytokines balance in episodic migraineurs. Although these findings are promising, it is needed to be extended.
The trial is registered in the Iranian registry of clinical trials (IRCT) at 11 July 2018, with IRCT code: IRCT20151128025267N6 ( https://www.irct.ir/trial/31246 ).
尽管偏头痛发病机制的确切机制仍不确定，并且已经开展了不同的研究来探讨神经炎症和免疫功能障碍的作用。因此，考虑到维生素D3的免疫保护功能，我们旨在研究每日补充2000国际单位（IU）D3对偏头痛患者免疫标志物血清状态的影响。
80名发作性偏头痛患者被随机分为两组，每组人数相等，分别接受2000 IU/d的维生素D3或安慰剂，为期12周。这项安慰剂对照双盲试验纳入了这些患者。通过酶联免疫吸附测定（ELISA）法在基线和试验结束后评估转化生长因子-β（TGF-β）和白细胞介素（IL）-17的血清浓度。
采用协方差分析（ANCOVA）对基线水平和混杂变量进行校正后发现，试验结束后，维生素D组的TGF-β血清水平（校正均值：1665.50 ng/L）显著高于安慰剂组（1361.90 ng/L）（P值 = 0.012）；另一方面，与对照组相比（校正均值：70.09 ng/L；P值 = 0.039），维生素D可防止试验后干预组IL-17血清水平升高（校正均值：37.84 ng/L）。Pearson相关性分析显示血清25-羟基维生素D（25(OH)D）变化与TGF-β之间存在显著正相关（r = - 0.306，P值 = 0.008）。相比之下，在整个研究过程中，血清25(OH)D与IL-17变化之间未发现显著相关性。
基于本研究结果，发现12周补充维生素D3（2000 IU/天）可增强发作性偏头痛患者中Th17/Treg相关细胞因子的平衡。尽管这些发现很有前景，但仍需要进一步扩展研究。
该试验于2018年7月11日在伊朗临床试验注册中心（IRCT）注册，IRCT编号：IRCT20151128025267N6（https://www.irct.ir/trial/31246 ）
