- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01994018
Correlation Between Relapses in Multiple Sclerosis (MS) and Vitamin D Intake
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Illinois
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Peoria, Illinois, Stati Uniti, 61637
- OSF Saint Francis Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
• Annual relapse rates
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Expanded Disability Status Scale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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non-response to immunodulators among patients who received MS treatment with or without vitamin D
Lasso di tempo: 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)
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Lasso di tempo |
---|---|
Serum Vitamin D levels in subjects taking GA with Vitamin D supplementation.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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 from the control group
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Reuben M Valenzuela, MD, OSF HealthCare System
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- OSF-13-002
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .