Vitamin D supplementation in patients with multiple sclerosis

• Register: EUCTR
• Last refreshed on: 8 January 2018
• Main ID: EUCTR2017-004846-31-SI
• Date of registration: 05/12/2017
• Prospective Registration: Yes
• Primary sponsor: University medical centre Maribor
• Public title: Vitamin D supplementation in patients with multiple sclerosis
• Scientific title: Impact of vitamin D supplementation in patients with multiple sclerosis
• Date of first enrolment: 14/12/2017
• Target sample size: 95
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004846-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Slovenia

Contacts

• Name: Neurology Department
• Affiliation: University Medical Centre Maribor

• Name: Neurology Department
• Affiliation: University Medical Centre Maribor

Key inclusion & exclusion 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:
• 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Relapsing remitting multiple sclerosis
MedDRA version: 20.1 Level: LLT Classification code 10064137 Term: Progression of multiple sclerosis System Organ Class: 100000004852

Intervention(s)

Trade Name: Oleovit D3 14.400 IU/ml oral drops, solution


Pharmaceutical Form: Oral drops, solution

Primary Outcome(s)

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)

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.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 4 months (December 2017-April 2018)

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

Secondary ID(s)

386022010017

Source(s) of Monetary Support

University medical centre Maribor