Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis, Relapsing-Remitting, Vitamin D Deficiency

Intervention / Treatment
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* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1000 IU/day of Vitamin D vs 4000 IU of Vitamin D /day; IU (international units)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1000 IU of vitamin D per day<br>Half of randomized patients will receive 1000 IU of vitamin D per day | Drug: Vitamin D<br>* 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.<br>* Other names: Oleovit D3;|
| Active Comparator: 4000 IU of vitamin D per day<br>Half of randomized patients will receive 4000 IU of vitamin D per day | Drug: Vitamin D<br>* 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.<br>* Other names: Oleovit D3;|

What is the study measuring?
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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 |