Clinical trial NCT03385356: Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis
Official title: Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis, Relapsing-Remitting
Vitamin D Deficiency
Lead sponsor: University Medical Centre Maribor
Sponsor class: OTHER
Collaborators: name: Medical Faculty Maribor
First posted: 2017-12-28
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1000 IU/day of Vitamin D vs 4000 IU of Vitamin D /day; IU (international units)
Primary purpose: TREATMENT

Brief summary: 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 healthy 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 randomized clinical trial was designed to compare impact of vitamin D supplementation 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 compare dose response on vitamin D supplementation and to estimate more closely appropriate level of vitamin D in serum which triggers some of experimentally shown immunomodulatory actions.

Detailed description: 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 healthy 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 randomized clinical trial was designed to compare impact of vitamin D supplementation during four months in winter time 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 compare dose response on vitamin D supplementation and estimate more closely appropriate level of vitamin D in serum which triggers some of experimentally shown immunomodulatory actions. To define immunomodulatory response different laboratory, clinical and genetic tests will be performed.

Eligibility criteria: Inclusion Criteria:

* Relapsing remitting MS
* Treatment with immunomodulatory drug
* Age 18-60 years and
* EDSS (Expanded Disability Status Scale) score less than 5.

Exclusion Criteria:

* Use of vitamin D supplements in the past 3 months
* Pregnancy, planning pregnancy or nursing
* Relapse of disease and corticosteroids use in past month
* Active inflammation at the start of the study (flu, cystitis etc.)
* Renal disease
* Elevated levels of calcium or parathormone
* Hypersensitivity to vitamin D preparations
* Switching of immunomodulatory drug in past 3 months
* Other autoimmune disease
* History of hyperparathyroidism, liver disease, tuberculosis, sarcoidosis or kidney stones

Primary outcomes:
measure: Vitamin D supplementation dose response
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maribor
country: Slovenia
facility: University Medical Centre Maribor
Study officials:
affiliation: University Medical Centre Maribor
name: Saša Gselman, MD
role: PRINCIPAL_INVESTIGATOR
References: