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Vitamin D Supplementation in Systemic Lupus Erythematosus (VITALUP)

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.
 
ClinicalTrials.gov Identifier: NCT01413230
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : November 24, 2011
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment
Vitamin D Deficiency Drug: cholecalciferol

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

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Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Prospective
Official Title: Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus
Study Start Date : January 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus Vitamin D


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


Primary Outcome Measures :
  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 Outcome Measures :
  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)


Biospecimen Retention:   Samples With DNA
blood with RNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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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
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Principal Investigator: Nathalie Costedoat-Chalumeau, PUPH Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01413230    
Other Study ID Numbers: Record AP
First Posted: August 10, 2011    Key Record Dates
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:
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Lupus Erythematosus, Systemic
Vitamin D Deficiency
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents