Vitamin D Supplementation in Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01413230
• Date of registration: 24/06/2011
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Vitamin D Supplementation in Systemic Lupus Erythematosus VITALUP
• Scientific title: Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus
• Date of first enrolment: January 2010
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01413230
• Study type: Observational
• Study design: Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Nathalie Costedoat-Chalumeau, PUPH
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Vitamin D Deficiency

Intervention(s)

Drug: cholecalciferol

Primary Outcome(s)

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]

Secondary Outcome(s)

Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation [Time Frame: 6 months]

Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI) [Time Frame: 6 months]

Secondary ID(s)

Record AP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors