Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis

NCT ID: NCT03385356

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-19
• Study Completion Date: 2018-04-30

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1000 IU of vitamin D per day

Half of randomized patients will receive 1000 IU of vitamin D per day

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: DRUG

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.

4000 IU of vitamin D per day

Half of randomized patients will receive 4000 IU of vitamin D per day

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Oleovit D3

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Faculty Maribor

UNKNOWN

Sponsor Role: collaborator

University Medical Centre Maribor

OTHER

Sponsor Role: lead

Responsible Party

Saša Gselman, M.D.

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saša Gselman, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Maribor

Locations

University Medical Centre Maribor

Maribor, , Slovenia

Countries

Slovenia

Other Identifiers

38602SUN17

Identifier Type: -

Identifier Source: org_study_id