Vitamin D Supplementation in Systemic Lupus Erythematosus (VITALUP)
Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus
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.
研究概览
详细说明
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.
Methods : This is an open prospective trial. SLE patients with hypovitaminosis D (< 30 ng/mL) receive vitamin D supplementation. 100 000 UI of cholecalciferol per week for 4 weeks then 100 000 UI of cholecalciferol per month for 6 months will be administered. All patients are followed after the beginning of vitamin D supplementation at month 2 and month 6.
End points :
- Clinical and biological tolerance: Absence of hypercalcemia or lithiasis during and after vitamin D supplementation.
- Immunologic follow-up of T cells and B cells homeostasis (including Treg and Th17) and gene expression profile in PBMCs using TRANSCRIPTOMIC analysis, before, during and after vitamin D supplementation.
- Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI) during and after vitamin D supplementation.
Schedule : Duration of patients' inclusion period is estimated 3
研究类型
注册 (实际的)
联系人和位置
学习地点
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-
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Paris、法国、75013
- Hôpital La Pitié Salpêtrière
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Paris、法国、75013
- CHU Pitié Salpétrière
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Paris、法国、75013
- Nathalie Costedoat-Chalumeau
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy
- Serum 25(OH)D levels > 30 ng/mL
- Flare requiring modification of treatments
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
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
大体时间: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
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation
大体时间:6 months
|
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)
大体时间:6 months
|
Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)
|
6 months
|
合作者和调查者
调查人员
- 首席研究员:Nathalie Costedoat-Chalumeau, PUPH、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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