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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.
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 :
Schedule : Duration of patients' inclusion period is estimated 3
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol | Drug | 100 000 UI of cholecalciferol per week during 4 then 100 000 UI of cholecalciferol per month for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with SLE
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie Costedoat-Chalumeau, PUPH | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Pitie Salpetriere | Paris | 75013 | France | |||
| Hopital la Pitie Salpétrière |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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blood with RNA
Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI) |
| 6 months |
| Paris |
| 75013 |
| France |
| Nathalie Costedoat-Chalumeau | Paris | 75013 | France |
| D009750 |
| Nutritional and Metabolic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |