- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01413230
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.
Studieoversigt
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Paris, Frankrig, 75013
- Hôpital La Pitié Salpétrière
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Paris, Frankrig, 75013
- CHU Pitié Salpétrière
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Paris, Frankrig, 75013
- Nathalie Costedoat-Chalumeau
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation
Tidsramme: 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)
Tidsramme: 6 months
|
Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)
|
6 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Nathalie Costedoat-Chalumeau, PUPH, Assistance Publique - Hôpitaux de Paris
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Autoimmune sygdomme
- Ernæringsforstyrrelser
- Bindevævssygdomme
- Avitaminose
- Mangelsygdomme
- Fejlernæring
- Lupus erythematosus, systemisk
- D-vitamin mangel
- Lægemidlers fysiologiske virkninger
- Mikronæringsstoffer
- Vitaminer
- Knogletæthedsbevarende midler
- Calciumregulerende hormoner og midler
- D-vitamin
- Cholecalciferol
Andre undersøgelses-id-numre
- Record AP
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