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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
89
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.
University Medical Centre Maribor
Maribor, Slovenia
Vitamin D supplementation dose response
Change in vitamin D level in serum after supplementation with 1000IU/day or 4000 IU/day.
Time frame: 4 months
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