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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Drug: cholecalciferol

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

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Hôpital La Pitié Salpêtrière
  • Paris, France, 75013
    • CHU Pitie Salpetriere
  • Paris, France, 75013
    • Nathalie Costedoat-Chalumeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient with SLE

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Nathalie Costedoat-Chalumeau, PUPH, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: June 24, 2011
• First Submitted That Met QC Criteria: August 5, 2011
• First Posted (Estimate): August 10, 2011

Study Record Updates

• Last Update Posted (Estimate): November 24, 2011
• Last Update Submitted That Met QC Criteria: November 23, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Systemic lupus erythematosus; regulatory T cells; vitamin D supplementation; Th17 cells
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Nutrition Disorders; Connective Tissue Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Lupus Erythematosus, Systemic; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: Record AP