Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated Syndrome

PHASE3CompletedINTERVENTIONAL
Enrollment

316

Participants

Timeline

Start Date

July 16, 2013

Primary Completion Date

January 4, 2023

Study Completion Date

January 4, 2023

Conditions
Multiple Sclerosis
Interventions
DRUG

Vitamin D

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.

DRUG

Placebo

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.

OTHER

Imaging

All patients are scheduled for MRI scans at baseline, 3 months, 12 months, 24 months, as well as upon conversion to full MS.

BIOLOGICAL

Lumbar puncture

A baseline collection of cerebral spinal fluid may be required for certain patients (doctor's decision.)

BIOLOGICAL

Blood sampling

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.

BIOLOGICAL

Urine samples

Urine samples are required of all patients at baseline, 3 months, 6 months, 12 months, 18 months, 24 months, and upon conversion to MS.

Trial Locations (33)

14033

CHU de Caen - Hôpital Côte de Nacre, Caen

21079

CHU de Dijon, Dijon

29107

CH de Cornouaille - Site Quimper - Hôpital Laennec, Quimper

30029

CHU de Nîmes - Hôpital Universitaire Carémeau, Nîmes

31059

CHRU de Toulouse - Hôpital Purpan, Toulouse

31700

Clinique des Cèdres - Capio, Cornebarrieu

34295

CHU de Montpellier - Hôpital Gui de Chauliac, Montpellier

35033

CHU de Rennes - Hôpital PontChaillou, Rennes

37044

CHRU de Tours - Hôpital Bretonneau, Tours

38043

CHU de Grenoble - Hôpital A Michallon, Grenoble

44093

CHU de Nantes - Hôtel-Dieu, Nantes

49403

CH de Saumur, Saumur

51092

CHU de Reims - Hôpital Maison Blanche, Reims

54035

CHU de Nancy - Hôpital Central, Nancy

59037

CHRU de Lille - Hôpital Roger Salengro, Lille

59462

Groupe Hospitalier de l'Institut Catholique de Lille, Lomme

63003

CHU de Clermont Ferrand - Hôpital Gabriel-Montpied, Clermont-Ferrand

64000

CH de Pau, Pau

66046

CH de Perpignan - Hôpital Saint Jean, Perpignan

67091

CHRU de Strasbourg - Hôpital Civil, Strasbourg

69677

CHU de Lyon - Hôpital Pierre Wertheimer, Bron

75013

MAILLART Elisabeth - La Pitié Salpétrière, Paris

75019

Fondation Ophtalmologique Adolphe Rothschild, Paris

75571

APHP - Hôpital Saint-Antoine, Paris

76031

CHU de Rouen - Hôpital Charles Nicolle, Rouen

78000

CH de Versailles - Hôpital Mignot, Versailles

78100

CH de Poissy - Saint-Germain-en-Laye, Saint-Germain-en-Laye

80054

CHU d'Amiens - Hôpital Nord, Amiens

87042

CHU de Limoges - Hôpital Dupuytren, Limoges

91100

CH Sud Francilien, Corbeil-Essonnes

97200

CHU de Martinique - Hôpital Pierre Zobda-Quitman, Fort-de-France

06002

CHU de Nice - Hôpital Pasteur, Nice

03207

CH de Vichy - Jacques Larin, Vichy

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nīmes

OTHER

NCT01817166 - Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated Syndrome | Biotech Hunter | Biotech Hunter