Vitamin D Supplementation in Systemic Lupus Erythematosus

NCT01413230 | Completed DMC

• 1 other identifier: Record AP
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Vitamin D Deficiency

Keywords

Systemic lupus erythematosus; vitamin D supplementation; regulatory T cells; Th17 cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

  6 months

Interventions

cholecalciferol DRUG

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

Also known as: 100 000 UI of cholecalciferol per week during 4, then 100 000 UI of cholecalciferol per month for 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with SLE

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Serum 25(OH)D levels \> 30 ng/mL
• Flare requiring modification of treatments

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Chu Pitie Salpetriere

Paris, 75013, France

Location

Hopital la Pitie Salpétrière

Paris, 75013, France

Location

Nathalie Costedoat-Chalumeau

Paris, 75013, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood with RNA

MeSH Terms

Conditions

Vitamin D Deficiency; Lupus Erythematosus, Systemic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Nathalie Costedoat-Chalumeau, PUPH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: August 10, 2011
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: November 24, 2011

Record last verified: 2011-06

Locations

FR (3)