CompletedPhase 3Early (CIS/RIS)NCT01817166

What it found

Met its main goal

The main measure showed a statistically significant benefit.

“Disease activity was observed in 94 patients (60.3%) in the vitamin D group and 109 patients (74.1%) in the placebo group (hazard ratio [HR], 0.66 [95% CI, 0.50-0.87]; P = .004), and median time to disease activity was longer in the vitamin D group (432 vs 224 days; log-rank P = .003).”
Read by software from the paper's abstract

Disease activity, defined as occurrence of a relapse and/or MRI activity (new and/or contrast-enhancing lesions) over 24 months of follow-up · 24 months

GroupnValue
Placebo153109 patients (74.1%)

hazard ratio 0.66

p = .004

Total participants: 316

Read by software from the paper's abstract

What was tested

Treatment tested

  • Ergocalciferol

    Vitamin D receptor agonist

  • Imaging
  • Lumbar puncture
  • Blood sampling
  • Urine samples

Placebo or sham

  • Placebo

What it measured

Main measures

  • Conversion to MS yes/no

    24 months

Other measures (75)

  • Number of relapse episodes (number per year)

    24 months

    Relapses
  • number of new brain lesions found in FLAIR MRI or medullary lesions found in T2 MRI

    3 months

    MRI lesions
  • number of new brain lesions found in FLAIR MRI or medullary lesions found in T2 MRI

    12 months

    MRI lesions
  • number of new brain lesions found in FLAIR MRI or medullary lesions found in T2 MRI

    24 months

    MRI lesions
  • Number of new T1 lesions taking on Gadolinium highlighting

    3 months

    MRI lesions
  • Number of new T1 lesions taking on Gadolinium highlighting

    12 months

    MRI lesions
  • Number of new T1 lesions taking on Gadolinium highlighting

    24 months

    MRI lesions
  • Number of hyposignal T1 lesions (black holes)

    3 months

    MRI lesions
  • Number of hyposignal T1 lesions (black holes)

    12 months

    MRI lesions
  • Number of hyposignal T1 lesions (black holes)

    24 months

    MRI lesions

Who could take part

Early (CIS/RIS) · 18 to 56

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 taking on contrast after injection of gadolinium Exclusion Criteria: * The patient is participating in another study (this criteria does not apply to the POLAR study (RCB 2011-A01269-32); patients included in this study may simultaneously participate in the POLAR study) * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant, parturient, or breastfeeding * Major medical or psychiatric illness that, according to the investigator, would result in the patient running an unnecessary risk or that could affect compliance with the study protocol * Vitamin D insufficiency linked to currently active digestive or more general diseases (celiac disease, inflammatory bowel disease, intestinal bypass, short bowel syndrome, cirrhosis, nephrotic syndrome, hyperthyroidism, rickets, hypoparathyroidism, cancer, granulomatous diseases and lymphomas) * Moderate or severe renal insufficiency (creatinine clearance less than 60 ml / min) * Epilepsy not adequately controlled by treatment * Any illness requiring chronic treatment with corticosteroids * Patient with osteoporosis or history of osteopenia * Pathology requiring calcium intakes greater than 1 gram per day * Current or past history of hypercalcemia * Medications that affect the metabolism of vitamin D other than corticosteroids; e.g. anticonvulsants [phenobarbital, primidone, phenytoin] rifampicin, isoniazid, ketoconazole, 5-FU and leucovorin, thiazide diuretics. * Situations accompanied by increased vulnerability to hypercalcemia, e.g. arrhythmia or known heart disease, treatment with digitalis, and subjects with nephrolithiasis. * Contraindications to vitamin D3 as mentioned in the documentation for UVEDOSE * Known hypersensitivity to gadolinium and / or known inability to undergo an MRI (pacemaker, osteosynthesis material, intraocular metal splinter, etc ....).

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

Loading reviews and guidelines…

Linked trials

  • Referred to by

    VDSS

    Not a drug-phase study · Completed

  • Referred to by

    PIXCIS

    Completed

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Jul 2013

    2. Main results due

      Jan 2023

    3. Finished

      Jan 2023

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