Trials / Completed
CompletedNCT01994018
Correlation Between Relapses in Multiple Sclerosis (MS) and Vitamin D Intake
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- OSF Healthcare System · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The correlation between relapses in MS and vitamin D intake will be examined.
Detailed description
Research suggests that a connection between vitamin D and MS could be tied to the positive effects vitamin D has on the immune system. Published data also shows a synergistic effect of vitamin D in conjunction with Glatiramer acetate (GA), an already approved FDA immunomodulating drug, in the treatment of multiple sclerosis. Further correlation of vitamin D and GA or Interferon Beta needs to be tested. This is a retrospective pilot study in which 100 patients diagnosed with relapsing-remitting MS (RR-MS) according to the McDonald criteria and treated with either GA or interferon with and without vitamin D supplementation for at least 2 years were included. Only RR-MS patients who received FDA approved immuno-modulatory drugs for MS are included in this review. Relapses before and during treatment will be analyzed and a subgroup analysis will be done on those who received vitamin D and those who did not. Magnetic resonance Imaging (MRI) of the brain and cervical spine of these MS patients will also be reviewed to see if there is any correlation between radiologic changes, relapses and vitamin D level. The 100 MS patients involved the chart review will be invited to participate in a one time blood draw to measure vitamin D levels. Additionally, the MS patients will be asked about their relapse status and medication history. Twenty (20) healthy individuals not on vitamin D supplementation will be used as controls to get a baseline vitamin D level.
Conditions
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2013-11-25
- Last updated
- 2022-04-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01994018. Inclusion in this directory is not an endorsement.