Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated Syndrome
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to evaluate the efficacy and tolerance of 2 years of
      treatment with cholecalciferol (vitamin D3) in patients with a clinically isolated syndrome
      at high risk for MS (CIS).
    

Detailed description: 
      The secondary objectives of this study are:

      A. evaluate clinical efficacy: delay to conversion; number of relapses/episodes per year B.
      evaluate efficacy in terms of resonance imaging parameters (cerebral/spinal MRI) C. evaluate
      efficacy in terms of slowing the progression of disability as measured by EDSS score and
      subscores D. measure and assess cognitive abilities (PASAT) E. evaluate changes in quality of
      life (EQ5D questionnaires, SF36, and TLS-TLS-QoL10 COPING10), fatigue questionnaire (FSMC)
      and anxiety / depression questionnaire (HADS) F. evaluate treatment tolerance G. to correlate
      changes in clinical and imaging parameters with the evolution of serum levels of 25(OH)D2 and
      25(OH)D3 H. establish a biobank of DNA and RNA from all patients in the study and conduct
      analyses of gene polymorphisms involved in the metabolism of vitamin D and the HLA system
      based on the increased levels of vitamin D after supplementation I. establish a biobank of
      CSF, plasma, blood cells, serum and RNA samples for patients in selected centers for research
      on prognostic biomarkers of conversion J. establish a biobank consisting of plasma tubes
      collected for the determination of 25-hydroxy-vitamin D K. Estimate the rate of discordance
      between the conversion decision made by the study neurologist and the result of the MRI
      re-interpretation performed at the end of the study as well as the proportion of patients
      identified a posteriori as as erroneously included according to the centralized reading.
    

Intervention name(s): Vitamin D; Placebo; Imaging; Lumbar puncture; Blood sampling; Urine samples
Intervention type(s): Drug; Drug; Other; Biological; Biological; Biological
Intervention description(s): Patients will receive 100.000 UI of cholecalciferol every 14 days for a maximum of 24 months or until conversion to full multiple sclerosis has occurred.; Patients will receive a placebo treatment mimicking 100.000 UI of cholecalciferol every 14 days for a maximum of 24 months or until conversion to full multiple sclerosis has occurred.; All patients are scheduled for MRI scans at baseline, 3 months, 12 months, 24 months, as well as upon conversion to full MS.; A baseline collection of cerebral spinal fluid may be required for certain patients (doctor's decision.); Blood sampling is required of all patients at baseline, 3 months, 6 months, 12 months, 18 months and 24 months, as well as upon conversion to MS.; Urine samples are required of all patients at baseline, 3 months, 6 months, 12 months, 18 months, 24 months, and upon conversion to MS.
Other intervention name(s): Cholecalciferol; Cerebro-medullar MRI
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cholecalciferol; vitamin D; immune disease; clinically isolated syndrome