Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting; Vitamin D Deficiency
• Intervention / Treatment: Drug: Vitamin D

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 4

Contacts and Locations

Study Locations

• Slovenia
  • Maribor, Slovenia, 2000
    • University Medical Centre Maribor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1000 IU of vitamin D per day; Half of randomized patients will receive 1000 IU of vitamin D per day	Drug: Vitamin D; Vitamin D supplementation of 1000IU vs 4000IU vitamin D per day for four months during winter time, when levels of vitamin D in serum of MS patients are especially low.; Other Names: Oleovit D3
Active Comparator: 4000 IU of vitamin D per day; Half of randomized patients will receive 4000 IU of vitamin D per day	Drug: Vitamin D; Vitamin D supplementation of 1000IU vs 4000IU vitamin D per day for four months during winter time, when levels of vitamin D in serum of MS patients are especially low.; Other Names: Oleovit D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D supplementation dose response	Change in vitamin D level in serum after supplementation with 1000IU/day or 4000 IU/day.	4 months

Collaborators and Investigators

• Sponsor: University Medical Centre Maribor
• Collaborators: Medical Faculty Maribor
• Investigators: Principal Investigator: Saša Gselman, MD, University Medical Centre Maribor

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 38602SUN17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No