- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01994018
Correlation Between Relapses in Multiple Sclerosis (MS) and Vitamin D Intake
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Illinois
-
Peoria, Illinois, Verenigde Staten, 61637
- OSF Saint Francis Medical Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
• Annual relapse rates
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Expanded Disability Status Scale
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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.
|
Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Serum Vitamin D levels in subjects taking GA with Vitamin D supplementation.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Within 30 days of consent or when patient is able
|
Within 30 days of consent or when patient is able
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Reuben M Valenzuela, MD, OSF HealthCare System
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- OSF-13-002
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .