Clinical trial NCT01413230: Vitamin D Supplementation in Systemic Lupus Erythematosus
Official title: Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Keywords: Systemic lupus erythematosus
vitamin D supplementation
regulatory T cells
Th17 cells
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with SLE

Brief summary: 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.

Detailed description: 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 :

1. Clinical and biological tolerance: Absence of hypercalcemia or lithiasis during and after vitamin D supplementation.
2. 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.
3. 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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation
timeFrame: 6 months
measure: Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Chu Pitie Salpetriere
city: Paris
country: France
facility: Hopital la Pitie Salpétrière
city: Paris
country: France
facility: Nathalie Costedoat-Chalumeau
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nathalie Costedoat-Chalumeau, PUPH
role: PRINCIPAL_INVESTIGATOR
References: