Vitamin D3 Supplementation and the T Cell Compartment in Multiple Sclerosis (MS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In patients with Relapsing Remitting Multiple Sclerosis (RRMS), the investigators observed a positive correlation between regulatory T cell (Treg) function and vitamin D status. The present goal is to assess whether Treg function improves on supplementation with vitamin D3.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple Sclerosis

NCT01753375

Multiple Sclerosis

UNKNOWN PHASE2

Vitamin D3 and the Stress-axis in MS

NCT02096133

Multiple Sclerosis

TERMINATED PHASE2

Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated Syndrome

NCT01817166

Multiple Sclerosis

COMPLETED PHASE3

Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)

NCT01339676

Multiple Sclerosis

UNKNOWN PHASE4

Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)

NCT01432704

Multiple Sclerosis

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In several studies, Multiple Sclerosis (MS) incidence and disease activity has been related with vitamin D status. We observed that RRMS patients who remained relapse free before blood collection had a better vitamin D status than patients who experienced relapses (Smolders et al. Mult Scler 2008;17:1220-1224). Since vitamin D3 is a potent promotor of T cell regulation in vitro (Smolders et al. J Neuroimmunol 2008;194:7-17), we hypothesised that a promotion of Treg function in MS patients might underlie its association with MS disease activity. In a cohort of RRMS patients, we observed a positive correlation of Treg function with vitamin D status (Smolders et al. PLoS ONE 2009;4:e6635). Furthermore, vitamin D status correlated positively with a Th1/Th2-balance which was more directed towards Th2. In the present study, we will assess whether treatment of RRMS patients with vitamin D3 promotes T cell regulation.

In the present study, RRMS patients will be supplemented with vitamin D3, and regulatory T cell tests will be performed before and after supplementation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin D3

Patients receive 1dd 500ug vitamin D3 for 3 months

Group Type EXPERIMENTAL

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Oil-based solution, 1 dose of 500 microgram each day, during 3 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vitamin D3

Oil-based solution, 1 dose of 500 microgram each day, during 3 months.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vigantol Oil (Merck)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Relapsing Remitting MS (Revised MCDonald criteria 2005)
* Age \> 18 years

Exclusion Criteria

* Progressive MS phenotype
* Abnormalities of vitamin D hormonal system other than low dietary intake or limited sun exposure
* Intake of drugs that influence vitamin D homeostasis other than corticosteroids
* Conditions with in increased susceptibility to hypercalcemia
* Alcohol or drug abuse
* Pregnancy or the intention to become pregnant within the study period

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No