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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994018
• Other study ID #: OSF-13-002
• Status: Completed
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: April 2022
• Source: OSF Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Recurrence
• Sclerosis

Locations

Country	Name	City	State
United States	OSF Saint Francis Medical Center	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OSF Healthcare System

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Smolders J, Moen SM, Damoiseaux J, Huitinga I, Holmøy 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum Vitamin D levels in subjects taking GA with Vitamin D supplementation.		Within 30 days of consent or when patient is able
Other	Serum Vitamin D levels in subjects taking GA without Vitamin D supplementation		Within 30 days of consent or when patient is able
Other	Serum vitamin D levels in subjects taking Interferon Beta with vitamin D supplementation		Within 30 days of consent or when patient is able
Other	Serum vitamin D levels in subjects taking Interferon Beta without vitamin D supplementation		Within 30 days of consent or when patient is able
Other	serum vitamin D levels from the control group		Within 30 days of consent or when patient is able
Primary	• 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	Expanded Disability Status Scale	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	Multiple Sclerosis Responders	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	Multiple Sclerosis Non-Responders	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	Response to immunodulators among patients who received MS treatment with or without vitamin D	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	non-response to immunodulators among patients who received MS treatment with or without vitamin D	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	MRI (brain images)	Data collected from retrospective chart review part of study.	after at least 2 years on therapy with an approved immuno-modulatory drug for MS.