Multiple Sclerosis, Relapsing-Remitting, Vitamin D Deficiency
Conditions
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.
Interventions
DRUGVitamin 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.
Sponsors
Medical Faculty Maribor
University Medical Centre Maribor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
1000 IU/day of Vitamin D vs 4000 IU of Vitamin D /day; IU (international units)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D supplementation dose response | 4 months | Change in vitamin D level in serum after supplementation with 1000IU/day or 4000 IU/day. |
Countries
Slovenia
Outcome results
None listed