Clinical Trials Directory

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.