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CompletedNCT01994018Updated Apr 29, 2022

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

An observational study in Multiple Sclerosis, sponsored by OSF Healthcare System. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-29.

Sponsored by OSF Healthcare System · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Vitamin D
  • Interferon Beta
  • Glatiramer Acetate
  • Relapse rates
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

OSF Healthcare System is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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.
05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. • Annual relapse rates

    Data collected from retrospective chart review part of study

    Time frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.

Secondary outcomes

  1. Expanded Disability Status Scale

    Data collected from retrospective chart review part of study.

    Time frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.

  2. Multiple Sclerosis Responders

    Data collected from retrospective chart review part of study.

    Time frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.

  3. Multiple Sclerosis Non-Responders

    Data collected from retrospective chart review part of study.

    Time frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.

  4. Response to immunodulators among patients who received MS treatment with or without vitamin D

    Data collected from retrospective chart review part of study.

    Time frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.

  5. non-response to immunodulators among patients who received MS treatment with or without vitamin D

    Data collected from retrospective chart review part of study.

    Time frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.

  6. MRI (brain images)

    Data collected from retrospective chart review part of study.

    Time frame: after at least 2 years on therapy with an approved immuno-modulatory drug for MS.

Other outcomes

  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

07

Study locations

1 site
  • OSF Saint Francis Medical Center
    Peoria, Illinois 61637, United States
08

References and documents

Publications

  • D'hooghe MB, Haentjens P, Nagels G, Garmyn M, De Keyser J. Sunlight exposure and sun sensitivity associated with disability progression in multiple sclerosis. Mult Scler. 2012 Apr;18(4):451-9. doi: 10.1177/1352458511423778. Epub 2011 Sep 27. PubMed 21952096 ↗
  • Smolders J, Moen SM, Damoiseaux J, Huitinga I, Holmoy T. Vitamin D in the healthy and inflamed central nervous system: access and function. J Neurol Sci. 2011 Dec 15;311(1-2):37-43. doi: 10.1016/j.jns.2011.07.033. Epub 2011 Aug 23. PubMed 21862439 ↗
  • O'Connor K, Weinstock-Guttman B, Carl E, Kilanowski C, Zivadinov R, Ramanathan M. Patterns of dietary and herbal supplement use by multiple sclerosis patients. J Neurol. 2012 Apr;259(4):637-44. doi: 10.1007/s00415-011-6226-3. Epub 2011 Sep 6. PubMed 21898138 ↗
  • Weinstock-Guttman B, Zivadinov R, Ramanathan M. Inter-dependence of vitamin D levels with serum lipid profiles in multiple sclerosis. J Neurol Sci. 2011 Dec 15;311(1-2):86-91. doi: 10.1016/j.jns.2011.07.024. Epub 2011 Aug 16. PubMed 21849177 ↗
  • McDowell TY, Amr S, Culpepper WJ, Langenberg P, Royal W, Bever C, Bradham DD. Sun exposure, vitamin D intake and progression to disability among veterans with progressive multiple sclerosis. Neuroepidemiology. 2011;37(1):52-7. doi: 10.1159/000329258. Epub 2011 Aug 5. PubMed 21822026 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01994018
Lead sponsor
OSF Healthcare System
Responsible party
Reuben Valenzuela (Reuben Mari Valenzuela, MD, OSF Healthcare System) — Principal investigator
First posted
Nov 25, 2013
Start date
Nov 2011
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Apr 29, 2022

Study contacts

Reuben M Valenzuela, MD
principal investigator · OSF Healthcare System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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