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Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis

NCT03385356 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2019-03-20

No results posted yet for this study

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.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting
  • Vitamin D Deficiency

Interventions

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.

Sponsors & Collaborators

  • Medical Faculty Maribor

    collaborator UNKNOWN

  • University Medical Centre Maribor

    lead OTHER

Principal Investigators

  • Saša Gselman, MD · University Medical Centre Maribor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Slovenia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03385356 on ClinicalTrials.gov