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Trial record 10 of 28 for:    multiple sclerosis | vitamin D

Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis

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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

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Vitamin D Deficiency Drug: Vitamin D Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
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
Official Title: Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis
Actual Study Start Date : December 19, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: 1000 IU of vitamin D per day
Half of randomized patients will receive 1000 IU of vitamin D per day
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

Active Comparator: 4000 IU of vitamin D per day
Half of randomized patients will receive 4000 IU of vitamin D per day
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385356


Locations
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Slovenia
University Medical Centre Maribor
Maribor, Slovenia, 2000
Sponsors and Collaborators
University Medical Centre Maribor
Medical Faculty Maribor
Investigators
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Principal Investigator: Saša Gselman, MD University Medical Centre Maribor

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Responsible Party: Saša Gselman, M.D., M.D., University Medical Centre Maribor
ClinicalTrials.gov Identifier: NCT03385356     History of Changes
Other Study ID Numbers: 38602SUN17
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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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
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Vitamin D
Vitamins
Vitamin D Deficiency
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents