Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Immunologic follow-up of T cells and B cells homeostasis (including regulatory T cells and Th17 cells) and gene expression profile of PBMCs using TRANSCRIPTOMIC analysis, before, during and after vitamin D supplementation
研究概览
简要总结
Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the skin, the joints, the nervous system and the kidney and may be life threatening.
SLE is associated with production of autoantibodies and perturbations in regulatory T cells and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).
Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.
Immunomodulatory effects of vitamin D supplementation in VITRO was recently described, notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and CD8+ T cells and the decrease of Th17 cells.
详细描述
Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the skin, the joints, the nervous system and the kidney and may be life threatening.
SLE is associated with production of autoantibodies and perturbations in regulatory T cells and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).
Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.
Immunomodulatory effects of vitamin D supplementation in VITRO was recently described, notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and CD8+ T cells and the decrease of Th17 cells.
Objective : To evaluate the cellular immune response after vitamin D supplementation in patients with SLE.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemic lupus erythematosus
- •Age > 18 years
- •Serum vitamin D levels [25(OH)D] < 30 ng/mL
- •Low to moderate active disease without modification of associated treatments
排除标准
- •Pregnancy
- •Serum 25(OH)D levels > 30 ng/mL
- •Flare requiring modification of treatments
结局指标
主要结局
Immunologic follow-up of T cells and B cells homeostasis (including regulatory T cells and Th17 cells) and gene expression profile of PBMCs using TRANSCRIPTOMIC analysis, before, during and after vitamin D supplementation
时间窗: 6 months
Immunologic follow-up of T cells and B cells homeostasis (including regulatory T cells and Th17 cells) and gene expression profile of PBMCs using TRANSCRIPTOMIC analysis, before, during and after vitamin D supplementation
次要结局
- Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation(6 months)
- Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)(6 months)