Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis

Phase 4

Completed

• Conditions: Vitamin D Deficiency; Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Vitamin D

• Registration Number: NCT03385356
• Lead Sponsor: University Medical Centre Maribor

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.

Study Timeline

• Study Start: 2017-12-19
• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1000 IU of vitamin D per day	Vitamin D	Half of randomized patients will receive 1000 IU of vitamin D per day
4000 IU of vitamin D per day	Vitamin D	Half of randomized patients will receive 4000 IU of vitamin D per day

Primary Outcome Measures

Name	Time	Method
Vitamin D supplementation dose response	4 months	Change in vitamin D level in serum after supplementation with 1000IU/day or 4000 IU/day.

Trial Locations

Locations (1)

University Medical Centre Maribor; 🇸🇮 Maribor, Slovenia