Trial record 2 of 2 for:    vitamin D and glatiramer acetate

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by OSF Healthcare System
Sponsor:
Information provided by (Responsible Party):
Reuben Valenzuela, OSF Healthcare System
ClinicalTrials.gov Identifier:
NCT01994018
First received: October 18, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Correlation Between Relapses in Multiple Sclerosis (MS) and Vitamin D Intake

Resource links provided by NLM:


Further study details as provided by OSF Healthcare System:

Primary Outcome Measures:
  • • Annual relapse rates [ Time Frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS. ] [ Designated as safety issue: No ]
    Data collected from retrospective chart review part of study


Secondary Outcome Measures:
  • Expanded Disability Status Scale [ Time Frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS. ] [ Designated as safety issue: No ]
    Data collected from retrospective chart review part of study.

  • Multiple Sclerosis Responders [ Time Frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS. ] [ Designated as safety issue: No ]
    Data collected from retrospective chart review part of study.

  • Multiple Sclerosis Non-Responders [ Time Frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS. ] [ Designated as safety issue: No ]
    Data collected from retrospective chart review part of study.

  • 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. ] [ Designated as safety issue: No ]
    Data collected from retrospective chart review part of study.

  • 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. ] [ Designated as safety issue: No ]
    Data collected from retrospective chart review part of study.

  • MRI (brain images) [ Time Frame: after at least 2 years on therapy with an approved immuno-modulatory drug for MS. ] [ Designated as safety issue: No ]
    Data collected from retrospective chart review part of study.


Other Outcome Measures:
  • Serum Vitamin D levels in subjects taking GA with Vitamin D supplementation. [ Time Frame: Within 30 days of consent or when patient is able ] [ Designated as safety issue: No ]
  • Serum Vitamin D levels in subjects taking GA without Vitamin D supplementation [ Time Frame: Within 30 days of consent or when patient is able ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • serum vitamin D levels from the control group [ Time Frame: Within 30 days of consent or when patient is able ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/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.

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994018

Contacts
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
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
Principal Investigator: Reuben M Valenzuela, MD OSF Healthcare System
  More Information

Additional Information:
No publications provided

Responsible Party: Reuben Valenzuela, Reuben Mari Valenzuela, MD, OSF Healthcare System
ClinicalTrials.gov Identifier: NCT01994018     History of Changes
Other Study ID Numbers: OSF-13-002
Study First Received: October 18, 2013
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by OSF Healthcare System:
Vitamin D
Interferon Beta
Glatiramer Acetate
Relapse rates

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Vitamins
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014