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).
Name: Vitamin D
Name: Placebo
Name: Imaging
Name: Lumbar puncture
Name: Blood sampling
Name: Urine samples
Description: Conversion to MS according to criteria described by McDonald (Polman et al 2005)
Measure: Conversion to MS yes/no Time: 24 monthsDescription: qualitative variable: 0, 1, or >1
Measure: Number of new T1 lesions taking on Gadolinium highlighting Time: 3 monthsDescription: qualitative variable: 0, 1, or >1
Measure: Number of new T1 lesions taking on Gadolinium highlighting Time: 12 monthsDescription: qualitative variable: 0, 1, or >1
Measure: Number of new T1 lesions taking on Gadolinium highlighting Time: 24 monthsDescription: Exact number (semiautomatic measure)
Measure: Total number of Gadolinium highlighted lesions on T1 images Time: 3 monthsDescription: Exact number (semiautomatic measure)
Measure: Total number of Gadolinium highlighted lesions on T1 images Time: 12 monthsDescription: Exact number (semiautomatic measure)
Measure: Total number of Gadolinium highlighted lesions on T1 images Time: 24 monthsDescription: mm^3
Measure: Normalized cerebral volume (SIENAX) obtained from a T13D sequence Time: 3 monthsDescription: mm^3
Measure: Normalized cerebral volume (SIENAX) obtained from a T13D sequence Time: 12 monthsDescription: mm^3
Measure: Normalized cerebral volume (SIENAX) obtained from a T13D sequence Time: 24 monthsDescription: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.
Measure: Presence/absence of adverse events Time: baselineDescription: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.
Measure: Presence/absence of adverse events Time: 3 monthsDescription: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.
Measure: Presence/absence of adverse events Time: 6 monthsDescription: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.
Measure: Presence/absence of adverse events Time: 12 monthsDescription: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.
Measure: Presence/absence of adverse events Time: 18 monthsDescription: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.
Measure: Presence/absence of adverse events Time: 24 monthsDescription: The number of days that pass from the beginning of treatment to conversion to MS according to McDonald 2005 criteria (Polman et al 2005)
Measure: Delay until conversion to MS Time: 24 monthsAllocation: Randomized
Parallel Assignment
There is one SNP
Normalized cerebral volume (SIENAX) obtained from a T13D sequence. --- T13D ---