Cholecalciferol
Drug100 000 UI of cholecalciferol per week during 4 then 100 000 UI of cholecalciferol per month for 6 months
Other names: 100 000 UI of cholecalciferol per week during 4, then 100 000 UI of cholecalciferol per month for 6 months
NCT Number: NCT01413230
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.
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Notify Me18 year and older
All sexes
Observational
Chu Pitie Salpetriere, Paris, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
100 000 UI of cholecalciferol per week during 4 then 100 000 UI of cholecalciferol per month for 6 months
Other names: 100 000 UI of cholecalciferol per week during 4, then 100 000 UI of cholecalciferol per month for 6 months
Time frame: 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
Time frame: 6 months
Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation
Time frame: 6 months
Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)
Assistance Publique - Hôpitaux de Paris
Other
Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus
Acronym: VITALUP
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