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NCT01490502 · ClinicalTrials.gov registry record · Phase 3
Vitamin D Supplementation in Multiple Sclerosis
A Phase 3 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 3
- Development phase
- 172
- Enrollment target
NCT01490502: Completed Phase 3 study, sponsored by Johns Hopkins University.
NCT01490502 is a Phase 3 study that has completed, run by Johns Hopkins University. The registered enrollment target is 172 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01490502, a Phase 3 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 172 participants
- Enrollment target
Study 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.
Primary Outcome
Confirmed relapse defined as new or worsening symptoms referable to the central nervous system, lasting at least 24 hours, occurring at least 30 days since the prior attack, accompanied by worsening of the EDSS (\>= 0.5 points) or in the Functional Systems (FS) scales (2 points on at least one FS scale or 1 point on \>= two FS scales).
Interventions
- DRUG Vitamin D3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2012-03 |
| Est. Completion | 2021-05-15 |
| Phase | Phase 3 |
What the finished NCT01490502 record still lists
NCT01490502 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Vitamin D3 is the first listed.
NCT01490502 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01490502 about?
NCT01490502 is a clinical study titled "Vitamin D Supplementation in Multiple Sclerosis". 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...
What is the current status of trial NCT01490502?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 172 participants. The study started on 2012-03. Estimated completion is 2021-05-15.
What interventions are being tested in trial NCT01490502?
The interventions under investigation include: Vitamin D3 (DRUG).
Who is sponsoring clinical trial NCT01490502?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01490502's enrollment target sits among peer trials
172 1448th of 2000 higher than 550 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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