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