Jhulia C N L da Mota, Lucas M Carvalho, Amanda A Ribeiro, Leticia L Souza, Eduardo F Borba, Hamilton Roschel, Bruno Gualano, Carolina F Nicoletti
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引用次数: 0
摘要
导言：最近有文献记录了系统性红斑狼疮（SLE）患者的DNA甲基化水平过低。在系统性红斑狼疮患者的 CD4+T 淋巴细胞中，在与免疫和炎症通路相关的基因中，已观察到 DNA 甲基化水平整体偏低。鉴于某些微量营养素可以在一碳代谢途径中捐献甲基，或作为参与 DNA 甲基化过程的酶的辅助因子，这项随机、双盲、安慰剂对照试验旨在研究叶酸和维生素 B12 的 3 个月补充是否会调节患有系统性红斑狼疮、体重正常或超重的女性皮下脂肪组织的 DNA 甲基化状况（主要结果）。作为次要目标，我们将评估基因表达、端粒长度和表型特征（即临床参数、体重和组成、腹围、食物摄入量和饮食不规律态度、体力活动、血脂概况、瘦素、脂肪连通素和细胞因子的血清浓度）：根据体重指数将患者的营养状况分为正常体重和超重体重两组。随后，每组患者将被随机分配到安慰剂组或干预组（补充叶酸（400 微克）和维生素 B12（2000 微克））。终点评估将采用意向治疗和按协议分析两种方法进行。这项研究有望设计出新的个性化营养方法，作为系统性红斑狼疮患者的辅助疗法：本研究已通过巴西圣保罗大学医学院临床医院伦理委员会的审查和批准（CAAE：试验注册号：NCT05097365（第一版）。
Methyl-donor supplementation in women with systemic lupus erythematosus with different nutritional status: the protocol for a randomised, double-blind, placebo-controlled trial.
Introduction: DNA hypomethylation in patients with systemic lupus erythematosus (SLE) has been recently documented in the literature. Low levels of DNA methylation have been observed globally and in genes associated with immune and inflammatory pathways in SLE's CD4+T lymphocytes. Given that certain micronutrients can either donate methyl groups within one-carbon metabolism pathways or serve as cofactors for enzymes involved in the DNA methylation process, this randomised, double-blind, placebo-controlled trial aims to investigate whether a 3-month supplementation of folic acid and vitamin B12 will modulate the DNA methylation profile in subcutaneous adipose tissue (primary outcome) of women with SLE and normal weight or excess body weight. As secondary objectives, we will assess gene expression, telomere length and phenotypic characteristics (ie, clinical parameters, body weight and composition, abdominal circumference, food intake and disordered eating attitude, physical activity, lipid profile, serum concentrations of leptin, adiponectin, and cytokines).
Methods and analysis: Patients will be classified according to their nutritional status by body mass index in normal weight or excess body weight. Subsequently, patients in each group will be randomly assigned to either a placebo or an intervention group (folic acid (400 mcg) and vitamin B12 (2000 mcg) supplementation). Endpoint evaluations will be conducted using both intention-to-treat and per-protocol analyses. This study has the potential to design new personalised nutritional approaches as adjunctive therapy for patients with SLE.
Ethics and dissemination: This study has been reviewed and approved by the Ethical Committee from Clinical Hospital of the School of Medicine of the University of Sao Paulo, Brazil (CAAE.: 47317521.8.0000.0068).
期刊介绍：
Lupus Science & Medicine is a global, peer reviewed, open access online journal that provides a central point for publication of basic, clinical, translational, and epidemiological studies of all aspects of lupus and related diseases. It is the first lupus-specific open access journal in the world and was developed in response to the need for a barrier-free forum for publication of groundbreaking studies in lupus. The journal publishes research on lupus from fields including, but not limited to: rheumatology, dermatology, nephrology, immunology, pediatrics, cardiology, hepatology, pulmonology, obstetrics and gynecology, and psychiatry.
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