Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis

Vitamin D Deficiency Clinical Trial

Official title:

Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385356
• Other study ID #: 38602SUN17
• Status: Completed
• Phase: Phase 4
• Start date: December 19, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: March 2019
• Source: University Medical Centre Maribor
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin 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.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Maribor	Maribor

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Maribor	Medical Faculty Maribor

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D supplementation dose response	Change in vitamin D level in serum after supplementation with 1000IU/day or 4000 IU/day.	4 months