Clinical trial NCT01994018: Correlation Between Relapses in Multiple Sclerosis (MS) and Vitamin D Intake
Official title: Correlation Between Relapses in Multiple Sclerosis (MS) and Vitamin D Intake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Vitamin D
Interferon Beta
Glatiramer Acetate
Relapse rates
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MS Group: Relapsing-remitting MS (RR-MS) patients according to the McDonald criteria who are treated with a FDA approved immuno-modulatory drugs.

Control Group: Healthy individuals not on vitamin D supplementation.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: • Annual relapse rates
timeFrame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
Secondary outcomes:
measure: Expanded Disability Status Scale
timeFrame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
measure: Multiple Sclerosis Responders
timeFrame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
measure: Multiple Sclerosis Non-Responders
timeFrame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
measure: Response to immunodulators among patients who received MS treatment with or without vitamin D
timeFrame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
measure: non-response to immunodulators among patients who received MS treatment with or without vitamin D
timeFrame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
measure: MRI (brain images)
timeFrame: after at least 2 years on therapy with an approved immuno-modulatory drug for MS.
Other outcomes:
measure: Serum Vitamin D levels in subjects taking GA with Vitamin D supplementation.
timeFrame: Within 30 days of consent or when patient is able
measure: Serum Vitamin D levels in subjects taking GA without Vitamin D supplementation
timeFrame: Within 30 days of consent or when patient is able
measure: Serum vitamin D levels in subjects taking Interferon Beta with vitamin D supplementation
timeFrame: Within 30 days of consent or when patient is able
measure: Serum vitamin D levels in subjects taking Interferon Beta without vitamin D supplementation
timeFrame: Within 30 days of consent or when patient is able
measure: serum vitamin D levels from the control group
timeFrame: Within 30 days of consent or when patient is able
Locations:
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
Study officials:
affiliation: OSF Healthcare System
name: Reuben M Valenzuela, MD
role: PRINCIPAL_INVESTIGATOR
References:
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