Impact of Vitamin D Supplementation in Patients With Multiple Sclerosi
Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 8 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Ergocalciferol
Vitamin D receptor agonist
What it measured
Main measures
Vitamin D supplementation dose response
4 months
Change in vitamin D level in serum after supplementation.
Other measures (1)
Change in gene expression of products of Th17 cells and their co-factors
Immune response
Who could take part
Relapsing MS · 18 to 60
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Dec 2017
Main results due
Apr 2018
Finished
Apr 2018