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Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03385356
Recruitment Status : Completed
First Posted : December 28, 2017
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Medical Faculty Maribor
Information provided by (Responsible Party):
Saša Gselman, M.D., University Medical Centre Maribor

Tracking Information
First Submitted Date  ICMJE December 20, 2017
First Posted Date  ICMJE December 28, 2017
Last Update Posted Date March 20, 2019
Actual Study Start Date  ICMJE December 19, 2017
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2017)		 Vitamin D supplementation dose response [ Time Frame: 4 months ]
Change in vitamin D level in serum after supplementation with 1000IU/day or 4000 IU/day.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis
Official Title  ICMJE Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
1000 IU/day of Vitamin D vs 4000 IU of Vitamin D /day; IU (international units)
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Sclerosis, Relapsing-Remitting
  • Vitamin D Deficiency
Intervention  ICMJE 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.
Other Name: Oleovit D3
Study Arms  ICMJE
  • Active Comparator: 1000 IU of vitamin D per day
    Half of randomized patients will receive 1000 IU of vitamin D per day
    Intervention: Drug: Vitamin D
  • Active Comparator: 4000 IU of vitamin D per day
    Half of randomized patients will receive 4000 IU of vitamin D per day
    Intervention: Drug: Vitamin D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2019)		 89
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2017)		 100
Actual Study Completion Date  ICMJE April 30, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03385356
Other Study ID Numbers  ICMJE 38602SUN17
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Saša Gselman, M.D., University Medical Centre Maribor
Study Sponsor  ICMJE University Medical Centre Maribor
Collaborators  ICMJE Medical Faculty Maribor
Investigators  ICMJE
Principal Investigator: Saša Gselman, MD University Medical Centre Maribor
PRS Account University Medical Centre Maribor
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP