CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 172 enrolled
Drug / intervention
Vitamin D3drug
Likely dose
Vitamin D3 600 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01490502
NCT01490502Phase 3Completed
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A Randomized Controlled Trial of Vitamin D Supplementation in Multiple Sclerosis

Johns Hopkins University·interventional·Posted Dec 13, 2011·Updated Sep 28, 2022

In Brief

A Phase 3 clinical trial evaluating Vitamin D3 for Relapsing Remitting Multiple Sclerosis. Completed, enrolled 172 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Remitting Multiple Sclerosis
CountriesUnited States
CollaboratorsOregon Health and Science University, University of California, San Francisco, Washington University School of Medicine, Icahn School of Medicine at Mount Sinai, University of Pennsylvania, Yale University, The Cleveland Clinic, University of Rochester, Stanford University, University of Virginia, Swedish Medical Center, Anne Arundel Health System Research Institute, Columbia University, University of Massachusetts, Worcester, Dignity Health

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 13, 2011
Enrollment StartMar 1, 2012
Primary CompletionMay 15, 2021
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 14.6 years ago

Interventions

Vitamin D3drug

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).