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

NCT01994018 | Completed

• 1 other identifier: OSF-13-002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Vitamin D; Interferon Beta; Glatiramer Acetate; Relapse rates

Outcome Measures

Primary Outcomes (1)

• • Annual relapse rates

  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 Outcomes (6)

• Expanded Disability Status Scale

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

• Multiple Sclerosis Responders

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

• Multiple Sclerosis Non-Responders

  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

  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

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

Other Outcomes (5)

• Serum Vitamin D levels in subjects taking GA with Vitamin D supplementation.

  Within 30 days of consent or when patient is able

• Serum Vitamin D levels in subjects taking GA without Vitamin D supplementation

  Within 30 days of consent or when patient is able

• Serum vitamin D levels in subjects taking Interferon Beta with vitamin D supplementation

  Within 30 days of consent or when patient is able

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• Patients diagnosed with MS sub-types other than RR-MS.

Sponsors & Collaborators

• OSF Healthcare System: lead

Study Sites (1)

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Related Publications (5)

• 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.

  PMID: 21952096 BACKGROUND

• 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.

  PMID: 21862439 BACKGROUND

• 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.

  PMID: 21898138 BACKGROUND

• 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.

  PMID: 21849177 BACKGROUND

• 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.

  PMID: 21822026 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Reuben M Valenzuela, MD

  OSF Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reuben Mari Valenzuela, MD

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

US (1)