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

22 kwietnia 2022 zaktualizowane przez: Reuben Valenzuela, OSF Healthcare System
The correlation between relapses in MS and vitamin D intake will be examined.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

100

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Illinois
      • Peoria, Illinois, Stany Zjednoczone, 61637
        • OSF Saint Francis Medical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
• Annual relapse rates
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Expanded Disability Status Scale
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Ramy czasowe
Serum Vitamin D levels in subjects taking GA with Vitamin D supplementation.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Within 30 days of consent or when patient is able
Within 30 days of consent or when patient is able

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

OSF Healthcare System

Śledczy

  • Główny śledczy: Reuben M Valenzuela, MD, OSF Healthcare System

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 listopada 2011

Zakończenie podstawowe (Rzeczywisty)

1 czerwca 2014

Ukończenie studiów (Rzeczywisty)

1 czerwca 2014

Daty rejestracji na studia

Pierwszy przesłany

18 października 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 listopada 2013

Pierwszy wysłany (Oszacować)

25 listopada 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 kwietnia 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 kwietnia 2022

Ostatnia weryfikacja

1 kwietnia 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • OSF-13-002

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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