- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01994018
Correlation Between Relapses in Multiple Sclerosis (MS) and Vitamin D Intake
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Illinois
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Peoria, Illinois, États-Unis, 61637
- OSF Saint Francis Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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.
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MS Group
RR-MS patients treated with a FDA approved immuno-modulatory drug with and without vitamin D supplementation for at least 2 years.
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Retrospective Chart Review
RR-MS patients treated with a FDA approved immuno-modulatory drug for MS.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
• Annual relapse rates
Délai: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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Data collected from retrospective chart review part of study
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After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Expanded Disability Status Scale
Délai: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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Data collected from retrospective chart review part of study.
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After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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Multiple Sclerosis Responders
Délai: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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Data collected from retrospective chart review part of study.
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After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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Multiple Sclerosis Non-Responders
Délai: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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Data collected from retrospective chart review part of study.
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After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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Response to immunodulators among patients who received MS treatment with or without vitamin D
Délai: 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.
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non-response to immunodulators among patients who received MS treatment with or without vitamin D
Délai: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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Data collected from retrospective chart review part of study.
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After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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MRI (brain images)
Délai: after at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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Data collected from retrospective chart review part of study.
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after at least 2 years on therapy with an approved immuno-modulatory drug for MS.
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Autres mesures de résultats
Mesure des résultats |
Délai |
---|---|
Serum Vitamin D levels in subjects taking GA with Vitamin D supplementation.
Délai: Within 30 days of consent or when patient is able
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Within 30 days of consent or when patient is able
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Serum Vitamin D levels in subjects taking GA without Vitamin D supplementation
Délai: Within 30 days of consent or when patient is able
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Within 30 days of consent or when patient is able
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Serum vitamin D levels in subjects taking Interferon Beta with vitamin D supplementation
Délai: Within 30 days of consent or when patient is able
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Within 30 days of consent or when patient is able
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Serum vitamin D levels in subjects taking Interferon Beta without vitamin D supplementation
Délai: Within 30 days of consent or when patient is able
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Within 30 days of consent or when patient is able
|
serum vitamin D levels from the control group
Délai: Within 30 days of consent or when patient is able
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Within 30 days of consent or when patient is able
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Reuben M Valenzuela, MD, OSF HealthCare System
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OSF-13-002
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