Universidade de Sao Paulo, Sao Paulo, Brazil.
Rheumatology, Universidade de Sao Paulo Faculdade de Medicina, Sao Paulo, Brazil.
Lupus Sci Med. 2024 Oct 7;11(2):e001279. doi: 10.1136/lupus-2024-001279.
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 B 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).
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 B (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.
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).
NCT05097365 (first version).
最近的文献中记录了系统性红斑狼疮（SLE）患者的 DNA 低甲基化。在 SLE 的 CD4+T 淋巴细胞中，已观察到整体和与免疫及炎症途径相关的基因中存在低水平的 DNA 甲基化。鉴于某些微量营养素可以在一碳代谢途径中提供甲基基团，或者作为参与 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 3 个月补充叶酸和维生素 B 是否会调节 SLE 女性正常体重或超重患者皮下脂肪组织（主要结局）的 DNA 甲基化谱。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、体重和成分、腰围、饮食摄入和饮食失调态度、身体活动、血脂谱、瘦素、脂联素和细胞因子的血清浓度）。
患者将根据体重指数分为正常体重或超重营养状况。随后，每组患者将随机分为安慰剂或干预组（叶酸（400 mcg）和维生素 B（2000 mcg）补充）。终点评估将采用意向治疗和方案分析进行。这项研究有可能设计出新的个性化营养方法，作为 SLE 患者的辅助治疗。
该研究已由巴西圣保罗大学医学院临床医院伦理委员会审查和批准（CAAE：47317521.8.0000.0068）。
NCT05097365（第一版）。
