Correlation Between Relapses in Multiple Sclerosis (MS) and Vitamin D Intake
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ClinicalTrials.gov Identifier: NCT01994018 |
Recruitment Status : Unknown
Verified November 2013 by Reuben Valenzuela, OSF Healthcare System.
Recruitment status was: Recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
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Condition or disease |
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Multiple Sclerosis |
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.
Study Type : | Observational |
Estimated Enrollment : | 120 participants |
Observational Model: | Case-Control |
Official Title: | Correlation Between Relapses in Multiple Sclerosis (MS) and Vitamin D Intake |
Study Start Date : | November 2011 |
Estimated Primary Completion Date : | September 2014 |
Estimated Study Completion Date : | September 2014 |

Group/Cohort |
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Control Group (Vitamin D level)
Twenty (20) healthy individuals not on vitamin D supplementation will be used as controls to get a baseline vitamin D level.
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MS Group
RR-MS patients treated with a FDA approved immuno-modulatory drug with and without vitamin D supplementation for at least 2 years.
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- • Annual relapse rates [ Time Frame: 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 [ Time Frame: 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 Responders [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: after at least 2 years on therapy with an approved immuno-modulatory drug for MS. ]Data collected from retrospective chart review part of study.
- Serum Vitamin D levels in subjects taking GA with Vitamin D supplementation. [ Time Frame: Within 30 days of consent or when patient is able ]
- Serum Vitamin D levels in subjects taking GA without Vitamin D supplementation [ Time Frame: Within 30 days of consent or when patient is able ]
- Serum vitamin D levels in subjects taking Interferon Beta with vitamin D supplementation [ Time Frame: Within 30 days of consent or when patient is able ]
- Serum vitamin D levels in subjects taking Interferon Beta without vitamin D supplementation [ Time Frame: Within 30 days of consent or when patient is able ]
- serum vitamin D levels from the control group [ Time Frame: Within 30 days of consent or when patient is able ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
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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:
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994018
Contact: Kimberly L Cooley, RN, BSN, CCRC | 309-655-4727 | kimberly.l.cooley@osfhealthcare.org | |
Contact: Stephanie G Madrigal, BS, CCRP, CHRC | 309-655-7397 | stephanie.g.madrigal@osfhealthcare.org |
United States, Illinois | |
OSF Saint Francis Medical Center | Recruiting |
Peoria, Illinois, United States, 61637 | |
Principal Investigator: Reuben M Valenzuela, MD |
Principal Investigator: | Reuben M Valenzuela, MD | OSF Healthcare System |
Responsible Party: | Reuben Valenzuela, Reuben Mari Valenzuela, MD, OSF Healthcare System |
ClinicalTrials.gov Identifier: | NCT01994018 |
Other Study ID Numbers: |
OSF-13-002 |
First Posted: | November 25, 2013 Key Record Dates |
Last Update Posted: | November 25, 2013 |
Last Verified: | November 2013 |
Vitamin D Interferon Beta Glatiramer Acetate Relapse rates |
Multiple Sclerosis Sclerosis Recurrence Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Disease Attributes |