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Vitamin D Supplementation in Systemic Lupus Erythematosus (VITALUP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01413230
First received: June 24, 2011
Last updated: November 23, 2011
Last verified: June 2011

June 24, 2011
November 23, 2011
January 2010
January 2011   (final data collection date for primary outcome 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01413230 on ClinicalTrials.gov Archive Site
  • Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation
  • Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)
Same as current
Not Provided
Not Provided
 
Vitamin D Supplementation in Systemic Lupus Erythematosus
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.

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

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood with RNA

Probability Sample

Patient with SLE

Vitamin D Deficiency
Drug: cholecalciferol
100 000 UI of cholecalciferol per week during 4 then 100 000 UI of cholecalciferol per month for 6 months
Other Names:
  • 100 000 UI of cholecalciferol per week during 4
  • then 100 000 UI of cholecalciferol per month for 6 months
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01413230
Record AP
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Nathalie Costedoat-Chalumeau, PUPH Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP