Multiple Sclerosis
Conditions
Keywords
Vitamin D, Interferon Beta, Glatiramer Acetate, Relapse rates
Brief 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.
Interventions
None listed
Sponsors
OSF Healthcare System
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Inclusion Criteria (MS Group): * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. * Be age 18 or older at the time of informed consent. * Have a diagnosis of relapsing-remitting multiple sclerosis (RR-MS) as defined by the McDonald Criteria. * Are taking FDA approved immune-modulatory drugs for MS. * Patients had at least one relapse during the year prior to initiation of MS treatment. * After at least 2 years on therapy, patients were classified as MS responders (MS-R) or MS non-responders (MS-NR) based on a clinical criteria recently reported in the literature. A responder (MS-R) is a patient with an annual relapse rate (ARR) \< 0.5 and no evidence of disease progression as measured by EDSS (expanded disability status scale). A hypo/non-responder (MS-NR) is a patient with an ARR \> 0.5 and/or with progression in the EDSS of at least 1 point sustained for 6 months. Inclusion Criteria (Control Group): * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. * Be age 18 or older at the time of informed consent. * Have not taken any vitamin D supplementation for more than 12 months.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • Annual relapse rates | After at least 2 years on therapy with an approved immuno-modulatory drug for MS. | Data collected from retrospective chart review part of study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Sclerosis Responders | After at least 2 years on therapy with an approved immuno-modulatory drug for MS. | Data collected from retrospective chart review part of study. |
| Expanded Disability Status Scale | After at least 2 years on therapy with an approved immuno-modulatory drug for MS. | Data collected from retrospective chart review part of study. |
| Multiple Sclerosis Non-Responders | After at least 2 years on therapy with an approved immuno-modulatory drug for MS. | Data collected from retrospective chart review part of study. |
| Response to immunodulators among patients who received MS treatment with or without vitamin D | After at least 2 years on therapy with an approved immuno-modulatory drug for MS. | Data collected from retrospective chart review part of study. |
| non-response to immunodulators among patients who received MS treatment with or without vitamin D | After at least 2 years on therapy with an approved immuno-modulatory drug for MS. | Data collected from retrospective chart review part of study. |
| MRI (brain images) | after at least 2 years on therapy with an approved immuno-modulatory drug for MS. | Data collected from retrospective chart review part of study. |
Other
| Measure | Time frame |
|---|---|
| Serum vitamin D levels in subjects taking Interferon Beta with vitamin D supplementation | Within 30 days of consent or when patient is able |
| Serum vitamin D levels in subjects taking Interferon Beta without vitamin D supplementation | Within 30 days of consent or when patient is able |
| serum vitamin D levels from the control group | Within 30 days of consent or when patient is able |
| Serum Vitamin D levels in subjects taking GA without Vitamin D supplementation | Within 30 days of consent or when patient is able |
| Serum Vitamin D levels in subjects taking GA with Vitamin D supplementation. | Within 30 days of consent or when patient is able |
Countries
United States
Outcome results
None listed