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Vitamin D Supplementation in Systemic Lupus Erythematosus

NCT ID: NCT01413230

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-01-31

Brief Summary

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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

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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

Conditions

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Vitamin D Deficiency

Keywords

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Systemic lupus erythematosus vitamin D supplementation regulatory T cells Th17 cells

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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cholecalciferol

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathalie Costedoat-Chalumeau, PUPH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Chu Pitie Salpetriere

Paris, , France

Site Status

Hopital la Pitie Salpétrière

Paris, , France

Site Status

Nathalie Costedoat-Chalumeau

Paris, , France

Site Status

Countries

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France

Other Identifiers

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Record AP

Identifier Type: -

Identifier Source: org_study_id