Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isol… (NCT01817166) | Clinical Trial Compass
CompletedPhase 3
Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated Syndrome
France316 participantsStarted 2013-07-16
Plain-language 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).
Who can participate
Age range18 Years – 56 Years
SexALL
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Inclusion Criteria:
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 24 months of follow-up
* The patient has had a classic CIS with the past 90 days
* Reference cerebro-medullary MRI scheduled within the 90 days after the beginning of symptoms
* With MRI (cerebro ± medullary) showing demyelination according to spatial spread criteria by Swanton (2006):
* At least 1 lesion in at least 2 of the 4 following territories: (1) Peri-ventricular; (2) Juxta-cortical; (3) Sub-tentorial; (4) Medullary
* No other suspected pathology
* Vitamin D level in blood less than 100 nmol / l at the pre-inclusion visit
* Women of childbearing potential must use very effective contraception for the duration of the study. A very effective contraceptive method is defined as a method resulting in a low failure rate (that is to say less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, IUDs, sexual abstinence, or partner with a vasectomy.
Randomisation stratification criteria:
* The patient can also also meet the temporal dissemination criteria defined according to McDonald criteria 2010 (Polman et al., 2011), because this condition is currently not sufficient for prescribing a background treatment: Simultaneous presence of at least one asymptomatic lesion taking on contrast and at least one asymptomatic lesion not …