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Vitamin D Supplementation in Systemic Lupus Erythematosus

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01413230
Acronym
VITALUP
Enrollment
20
Registered
2011-08-10
Start date
2010-01-31
Completion date
2011-01-31
Last updated
2011-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

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

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.

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

Interventions

DRUGcholecalciferol

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 supplementation6 monthsImmunologic 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

MeasureTime frameDescription
Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation6 monthsClinical 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)6 monthsClinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026