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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
Sponsor:
Information provided by (Responsible Party):
Reuben Valenzuela, OSF Healthcare System

Study Description
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Brief Summary:
The correlation between relapses in MS and vitamin D intake will be examined.

Condition or disease
Multiple Sclerosis

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.

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Groups and Cohorts
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Group/Cohort
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.
MS Group
RR-MS patients treated with a FDA approved immuno-modulatory drug with and without vitamin D supplementation for at least 2 years.


Outcome Measures
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Primary Outcome Measures :
  1. • 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Other Outcome Measures:
  1. Serum Vitamin D levels in subjects taking GA with Vitamin D supplementation. [ Time Frame: Within 30 days of consent or when patient is able ]
  2. Serum Vitamin D levels in subjects taking GA without Vitamin D supplementation [ Time Frame: Within 30 days of consent or when patient is able ]
  3. 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 ]
  4. 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 ]
  5. serum vitamin D levels from the control group [ Time Frame: Within 30 days of consent or when patient is able ]

Eligibility Criteria
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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
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.

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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
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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

Locations
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United States, Illinois
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Principal Investigator: Reuben M Valenzuela, MD         
Sponsors and Collaborators
OSF Healthcare System
Investigators
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Principal Investigator: Reuben M Valenzuela, MD OSF Healthcare System
More Information
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Publications:
3. J Neurol. 2011 Sep 6. [Epub ahead of print] PubMed PMID: Patterns of dietary and herbal supplement use by multiple sclerosis patients 21898138O'Connor K, Weinstock-Guttman B, Carl E, Kilanowski C, Zivadinov R, Ramanathan
4. J Neurol Sci. 2011 Aug 15. [Epub ahead of print] PubMed PMID: 21849177. Inter-dependence of vitamin D levels with serum lipid profiles in multiple sclerosis -Guttman B, Zivadinov R, Ramanathan M.

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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
Keywords provided by Reuben Valenzuela, OSF Healthcare System:
Vitamin D
Interferon Beta
Glatiramer Acetate
Relapse rates
Additional relevant MeSH terms:
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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