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

April 22, 2022 updated by: Reuben Valenzuela, OSF Healthcare System
The correlation between relapses in MS and vitamin D intake will be examined.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.
Retrospective Chart Review
RR-MS patients treated with a FDA approved immuno-modulatory drug for MS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• 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
After at least 2 years on therapy with an approved immuno-modulatory drug for MS.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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.
After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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.
After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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.
After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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.
After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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.
after at least 2 years on therapy with an approved immuno-modulatory drug for MS.

Other Outcome Measures

Outcome Measure
Time Frame
Serum Vitamin D levels in subjects taking GA with Vitamin D supplementation.
Time Frame: Within 30 days of consent or when patient is able
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
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
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
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
Within 30 days of consent or when patient is able

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OSF Healthcare System

Investigators

  • Principal Investigator: Reuben M Valenzuela, MD, OSF Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 18, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSF-13-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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