Relapsing remitting multiple sclerosis MedDRA version: 20.1 Level: LLT Classification code 10064137 Term: Progression of multiple sclerosis System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Oleovit D3 14.400 IU/ml oral drops, solution
Pharmaceutical Form: Oral drops, solution
Sponsors
University medical centre Maribor
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Relapsing remitting MS • Treatment with immunomodulatory drug • Age 18-60 years and • EDSS score less than 5. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Use of vitamin D supplements in the past 3 months • Pregnancy, planing pregnancy or nursing • Relapse of disease and corticosteroide use in past month • Active inflammmation at the start of the study (flu, cystitis etc.) • Renal disease • Elevated levels od calcium or parathormone • Hypersensitivity to vitamin D prepartions • Switching of immunomodulatory drug in past 3 months • Other autoimmune disease • History of hyperparathyroidism, liver disease, tuberculosis, sarcoidosis or kidney stones
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Vitamin D is important risk factor for developing multiple sclerosis (MS) and for disease progression. Patients with MS who had lower vitamin D levels were at increased risk for more clinical attacks and faster disease progression. It was also shown that patients with MS had lower vitamin D levels in serum than heathy controls. It is not clearly defined, which are the levels of vitamin D in serum, that are high enough to trigger immunomodulatory effect and are safe for patients. This double-blind randomised clinical trial was designed to compare impact of vitamin D supplemetation in two different doses (1000 IU/day vs 4000 IU/day) in patients with relapsing remitting MS. The main goal of this trial is to show, which dose triggers immunomodulatory effect and it will be suitable for patients with MS to use during winter time, when the vitamin D levels are especially low. To define immunomodulatory response different laboratory, clinical and genetic tests will be performed. ;Secondary Objective: The secondary objectives of this clinical trial are to: • measure basic level of vitamin D in serum in patients with MS during winter time, • perform the genotypization of selected SNP's and try to determine pharmacogenomic linkage with effect of vitamin D supplementation, • measure gene expression of products of Th17 cells and their co-factors, • measure microRNA expression (miR-155) before and after vitamin D supplementation. ;Primary end point(s): Change in vitamin D level in serum after supplementation. ;Timepoint(s) of evaluation of this end point: 4 months (December 2017-April 2018) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in gene expression of products of Th17 cells and their co-factors Change in miR-155 expression before and after vitamin D supplementation. Genotypization of selected SNP's and try to determine pharmacogenomic linkage with effect of vitamin D supplementation;Timepoint(s) of evaluation of this end point: 4 months (December 2017-April 2018) | — |
Countries
Slovenia
Contacts
Public ContactNeurology Department
University Medical Centre Maribor
Outcome results
None listed