Overview

Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis

Status:
Completed
Trial end date:
2018-04-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Medical Centre Maribor
Collaborator:
Medical Faculty Maribor
Treatments:
Vitamin D
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