Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis

NCT03385356 | Completed Phase 4

• 1 other identifier: 38602SUN17
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Vitamin D supplementation dose response

  Change in vitamin D level in serum after supplementation with 1000IU/day or 4000 IU/day.

  4 months

Study Arms (2)

1000 IU of vitamin D per day

ACTIVE COMPARATOR

Half of randomized patients will receive 1000 IU of vitamin D per day

Drug: Vitamin D

4000 IU of vitamin D per day

ACTIVE COMPARATOR

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

Drug: Vitamin D

Interventions

Vitamin D DRUG

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.

Also known as: Oleovit D3

1000 IU of vitamin D per day; 4000 IU of vitamin D per day

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Relapsing remitting MS
• Treatment with immunomodulatory drug
• Age 18-60 years and
• EDSS (Expanded Disability Status Scale) score less than 5.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Maribor: lead
• Medical Faculty Maribor: collaborator

Study Sites (1)

University Medical Centre Maribor

Maribor, 2000, Slovenia

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Multiple Sclerosis; 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; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Saša Gselman, MD

  University Medical Centre Maribor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: 1000 IU/day of Vitamin D vs 4000 IU of Vitamin D /day; IU (international units)

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: December 19, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Locations

SL (1)