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Vitamin D Supplementation in Systemic Lupus Erythematosus (VITALUP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01413230
First Posted: August 10, 2011
Last Update Posted: November 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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.


Condition Intervention
Vitamin D Deficiency Drug: cholecalciferol

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • 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)


Biospecimen Retention:   Samples With DNA
blood with RNA

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with SLE
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413230


Locations
France
Chu Pitie Salpetriere
Paris, France, 75013
Hopital la Pitie Salpétrière
Paris, France, 75013
Nathalie Costedoat-Chalumeau
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Nathalie Costedoat-Chalumeau, PUPH Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01413230     History of Changes
Other Study ID Numbers: Record AP
First Submitted: June 24, 2011
First Posted: August 10, 2011
Last Update Posted: November 24, 2011
Last Verified: June 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Systemic lupus erythematosus
vitamin D supplementation
regulatory T cells
Th17 cells

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Vitamin D Deficiency
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents