Vitamin D Supplementation in Multiple Sclerosis

Summary

Low vitamin D levels have been shown to increase a person's risk of developing multiple sclerosis (MS), and patients with MS who have lower vitamin D levels are at increased risk of having attacks. However, it is not known if giving supplemental vitamin D to those with MS reduces the risk of attacks, and some research suggests that vitamin D could even be harmful to people with MS.

In this clinical trial, patients with relapsing-remitting MS will receive high-dose or low-dose oral vitamin D in addition to an approved therapy for MS, glatiramer acetate. Patients will be evaluated for two years, and the effect of high-dose vitamin D supplementation on the rate of MS attacks and on the number of new lesions and change in brain volume on MRI will be determined. Establishing this association will have major implications for the treatment of individuals with MS throughout the world.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

Vitamin D3

Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).

Sponsors & Collaborators

• Oregon Health and Science University

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Yale University

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Swedish Medical Center

  collaborator OTHER

• Anne Arundel Health System Research Institute

  collaborator OTHER

• Columbia University

  collaborator OTHER

• University of Massachusetts, Worcester

  collaborator OTHER

• Dignity Health

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Ellen M Mowry, MD, MCR · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2021-05-15

Completion

2021-05-15

FDA Drug

Yes

Countries

• United States

Study Locations