Correlation Between Relapses in Multiple Sclerosis (MS) and Vitamin D Intake

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.

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:

- Exclusion Criteria (MS Group):

- Those who have a diagnosis of secondary progressive MS (SPMS) or primary
progressive MS (PPMS).

- Unwillingness or inability to comply with the requirements of this protocol,
including the presence of any condition (physical, mental, or social) that is
likely to affect the subject's ability to comply with the study protocol.

- Any other condition, clinical finding, or reason that, in the opinion of the
Investigator, is determined to be unsuitable for enrollment into this study.

- Those who received other forms of treatment under than a FDA approved MS drugs
are excluded.

Exclusion Criteria(Control Group):

- Unwillingness or inability to comply with the requirements of this protocol,
including the presence of any condition (physical, mental, or social) that is likely
to affect the subject's ability to comply with the study protocol.

- History of osteoporosis, kidney disease, parathyroid disease, problems with calcium
metabolism, sacrcoidosis, and/or pregnancy.

- Current nursing home or bed bound patients.

- Any other condition, clinical finding, or reason that, in the opinion of the
Investigator, is determined to be unsuitable for enrollment into this study.