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

OSF Healthcare System

Status

Completed

Conditions

Multiple Sclerosis

Study type

Observational

Funder types

Other

Identifiers

NCT01994018

OSF-13-002

Details and patient eligibility

About

The correlation between relapses in MS and vitamin D intake will be examined.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Inclusion Criteria (Retrospective Chart Review) • Only RR-MS patients who received FDA approved immuno-modulatory drugs for MS.

Exclusion Criteria (Retrospective Chart Review)

• Patients diagnosed with MS sub-types other than RR-MS.