Vitamin D Supplementation in Systemic Lupus Erythematosus

Vitamin D Deficiency Clinical Trial

— VITALUP  

Official title:

Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413230
• Other study ID #: Record AP
• Status: Completed
• Phase: N/A
• First received: June 24, 2011
• Last updated: November 23, 2011
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: June 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Vitamin D Deficiency

Intervention

Drug:
• cholecalciferol
100 000 UI of cholecalciferol per week during 4 then 100 000 UI of cholecalciferol per month for 6 months

Locations

Country	Name	City	State
France	Chu Pitie Salpetriere	Paris
France	Hopital la Pitie Salpétrière	Paris
France	Nathalie Costedoat-Chalumeau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)	Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)	6 months	No