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Completed

NCT Number: NCT01413230

Vitamin D Supplementation in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Pitie Salpetriere, Paris, France

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About this study

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 :

  • Clinical and biological tolerance: Absence of hypercalcemia or lithiasis during and after vitamin D supplementation.
  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

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

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

    Time frame: 6 months

    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

Secondary outcomes

  1. Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation

    Time frame: 6 months

    Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation

  2. Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: VITALUP

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 10, 2011
Registry last updated
Nov 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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