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Vitamin D Supplementation in Systemic Lupus Erythematosus (VITALUP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01413230
First received: June 24, 2011
Last updated: November 23, 2011
Last verified: June 2011
  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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01413230     History of Changes
Other Study ID Numbers: Record AP
Study First Received: June 24, 2011
Last Updated: November 23, 2011
Health Authority: France: Ministry of Health

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
Autoimmune Diseases
Avitaminosis
Connective Tissue Diseases
Deficiency Diseases
Immune System Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014