Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients
23 kwietnia 2019 zaktualizowane przez: Vahid Shaygannejad, Isfahan University of Medical Sciences
Evaluating the Effect of Fingolimod With Fish Oil Compared to Fingolimod With Placebo on Tumor Necrosis Factor-α , Interleukin1b , Interleukin6, and Interferon-gamma in Patients With Relapsing-Remitting Multiple Sclerosis
This study evaluates the effect of adding fish oil to Fingolimod on some serum cytokines in patients with Relapsing-Remitting Multiple Sclerosis.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
Multiple Sclerosis (MS) is a chronic autoimmune disease characterized by inflammatory demyelinative lesions in central nervous system. Relapsing-Remitting MS is the most common form of the disease observed in 85% of patients. This form presents with acute or sub-acute onset of neurological symptoms and patients may fully or partially recover and relapses may occur from time to time.
Regarding MS pathogenesis, the findings suggest the role of environmental factors in triggering the innate immune system and activating T cells and the onset of a chronic inflammatory response against myelin antigens in the central nervous system in people who are genetically prone to the disease. Among immune cells, T helper 17 (Th17) plays an important role in autoimmune response and are shown to be involved in clinical course of Relapsing-Remitting MS. Th17 cell differentiation is controlled by several cytokines, including interleukin-6 (IL-6), interleukin-1b (IL-1b) and interleukin-10 (IL-10). Also, IL 6 have an inhibitory effect on Th17 cell differentiation through increased production of interferon-gamma (IFN-gamma) and IL 10.
Currently, immunomodulatory drugs are considered as the first line treatment in MS. Fingolimod is the first oral immunomodulatory medication used for Relapsing-Remitting MS. It is phosphorylated by crossing the blood-brain barrier and is converted to its active metabolite, Fingolimod-P. This metabolite acts as a Sphingosine-1-phosphate receptor (S1PR1) on oligodendrocytes, microglias, astrocytes, and neurons and inhibits the entry of lymphocytes into the central nervous system. Therefore, it reduces demyelination and may also lead to remyelination.
Nutrition is known as a possible environmental factor in pathogenesis of MS. Positive clinical and biological effects of dietary supplements containing polyunsaturated fatty acids omega -3 (PUFA) in the course of autoimmune diseases such as MS have been studied. High levels of PUFA is found in fish oil which is also known as an antioxidant, anti-inflammatory and immunomodulatory agent. Several studies have evaluated the effect of fish oil as a dietary supplement in the treatment of MS however, conflicting findings are reported.
In this study, the investigators aim to evaluate the effect of Fingolimod with Fish oil compared to Fingolimod with placebo on TNF-α, IL1b, IL6, and IFN-gamma in patients with Relapsing-Remitting Multiple sclerosis.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
50
Faza
- Faza 2
- Faza 3
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 do 45 lat (Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Patients with relapsing-remitting multiple sclerosis according to McDonald's criteria (2010)
- Age between 18 and 45 years
- Expanded Disability Status Scale (EDSS) between 0-5
- History of at least one relapse during the last year
- Intolerance or serious complications when receiving interferons
- Not receiving interferons in the last two months
- Not having relapse in the last 30 days
- Negative pregnancy test
- History of varicella or varicella vaccination, or positive test for anti-varicella antibodies
- Not to take any medication or dietary complement without permission of the physician
- Filling informed consent
Exclusion Criteria:
- Having chronic and infectious diseases
- History of cardiovascular diseases
- Taking corticosteroids in the last 30 days
- Taking chemotherapy agents such as Cyclophosphamide
- Patients who have taken fingolimod before
- Patients who experience relapse during the study
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
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Fingolimod and Fish Oil
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
|
Produced by Osveh ® Pharm Company in Iran
Inne nazwy:
produced by Zahravi ® Pharm Company in Iran
Inne nazwy:
|
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Aktywny komparator: Fingolimod and Placebo
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
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Produced by Osveh ® Pharm Company in Iran
Inne nazwy:
placebo capsules to mimic Fish Oil 1 g capsules
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Serum Level of TNF-α
Ramy czasowe: Baseline
|
5 cc of venous blood is taken from patients and are kept in test tubes without ethylenediaminetetraacetic acid (EDTA).
Test tubes are kept one hour immobilized so that clotted blood and serum are separated.
Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes.
Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.
|
Baseline
|
|
Serum Level of IL1b
Ramy czasowe: Baseline
|
5 cc of venous blood is taken from patients and are kept in test tubes without EDTA.
Test tubes are kept one hour immobilized so that clotted blood and serum are separated.
Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes.
Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.
|
Baseline
|
|
Serum Level of IL6
Ramy czasowe: Baseline
|
5 cc of venous blood is taken from patients and are kept in test tubes without EDTA.
Test tubes are kept one hour immobilized so that clotted blood and serum are separated.
Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes.
Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.
|
Baseline
|
|
Serum Level of IFN-gamma
Ramy czasowe: Baseline
|
5 cc of venous blood is taken from patients and are kept in test tubes without EDTA.
Test tubes are kept one hour immobilized so that clotted blood and serum are separated.
Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes.
Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.
|
Baseline
|
|
Serum Level of TNF-α
Ramy czasowe: 6 months after intervention
|
5 cc of venous blood is taken from patients and are kept in test tubes without EDTA.
Test tubes are kept one hour immobilized so that clotted blood and serum are separated.
Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes.
Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.
|
6 months after intervention
|
|
Serum Level of TNF-α
Ramy czasowe: 1 year after intervention
|
5 cc of venous blood is taken from patients and are kept in test tubes without EDTA.
Test tubes are kept one hour immobilized so that clotted blood and serum are separated.
Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes.
Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.
|
1 year after intervention
|
|
Serum Level of IL1b
Ramy czasowe: 6 months after intervention
|
5 cc of venous blood is taken from patients and are kept in test tubes without EDTA.
Test tubes are kept one hour immobilized so that clotted blood and serum are separated.
Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes.
Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.
|
6 months after intervention
|
|
Serum Level of IL1b
Ramy czasowe: 1 year after intervention
|
5 cc of venous blood is taken from patients and are kept in test tubes without EDTA.
Test tubes are kept one hour immobilized so that clotted blood and serum are separated.
Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes.
Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.
|
1 year after intervention
|
|
Serum Level of IL6
Ramy czasowe: 6 months after intervention
|
5 cc of venous blood is taken from patients and are kept in test tubes without EDTA.
Test tubes are kept one hour immobilized so that clotted blood and serum are separated.
Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes.
Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.
|
6 months after intervention
|
|
Serum Level of IL6
Ramy czasowe: 1 year after intervention
|
5 cc of venous blood is taken from patients and are kept in test tubes without EDTA.
Test tubes are kept one hour immobilized so that clotted blood and serum are separated.
Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes.
Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.
|
1 year after intervention
|
|
Serum Level of IFN-gamma
Ramy czasowe: 6 months after intervention
|
5 cc of venous blood is taken from patients and are kept in test tubes without EDTA.
Test tubes are kept one hour immobilized so that clotted blood and serum are separated.
Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes.
Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.
|
6 months after intervention
|
|
Serum Level of IFN-gamma
Ramy czasowe: 1 year after intervention
|
5 cc of venous blood is taken from patients and are kept in test tubes without EDTA.
Test tubes are kept one hour immobilized so that clotted blood and serum are separated.
Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes.
Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.
|
1 year after intervention
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Krzesło do nauki: Shaygannejad Shaygannejad, M.D., Isfahan University of Medical Sciences
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
- Aktas O, Kury P, Kieseier B, Hartung HP. Fingolimod is a potential novel therapy for multiple sclerosis. Nat Rev Neurol. 2010 Jul;6(7):373-82. doi: 10.1038/nrneurol.2010.76. Epub 2010 Jun 15.
- Brinkmann V, Billich A, Baumruker T, Heining P, Schmouder R, Francis G, Aradhye S, Burtin P. Fingolimod (FTY720): discovery and development of an oral drug to treat multiple sclerosis. Nat Rev Drug Discov. 2010 Nov;9(11):883-97. doi: 10.1038/nrd3248. Epub 2010 Oct 29.
- Gallai V, Sarchielli P, Trequattrini A, Franceschini M, Floridi A, Firenze C, Alberti A, Di Benedetto D, Stragliotto E. Cytokine secretion and eicosanoid production in the peripheral blood mononuclear cells of MS patients undergoing dietary supplementation with n-3 polyunsaturated fatty acids. J Neuroimmunol. 1995 Feb;56(2):143-53. doi: 10.1016/0165-5728(94)00140-j.
- Kappos L, Radue EW, O'Connor P, Polman C, Hohlfeld R, Calabresi P, Selmaj K, Agoropoulou C, Leyk M, Zhang-Auberson L, Burtin P; FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):387-401. doi: 10.1056/NEJMoa0909494. Epub 2010 Jan 20.
- Nordvik I, Myhr KM, Nyland H, Bjerve KS. Effect of dietary advice and n-3 supplementation in newly diagnosed MS patients. Acta Neurol Scand. 2000 Sep;102(3):143-9. doi: 10.1034/j.1600-0404.2000.102003143.x.
- Ramirez-Ramirez V, Macias-Islas MA, Ortiz GG, Pacheco-Moises F, Torres-Sanchez ED, Sorto-Gomez TE, Cruz-Ramos JA, Orozco-Avina G, Celis de la Rosa AJ. Efficacy of fish oil on serum of TNF alpha , IL-1 beta , and IL-6 oxidative stress markers in multiple sclerosis treated with interferon beta-1b. Oxid Med Cell Longev. 2013;2013:709493. doi: 10.1155/2013/709493. Epub 2013 Jun 18.
- Torkildsen O, Wergeland S, Bakke S, Beiske AG, Bjerve KS, Hovdal H, Midgard R, Lilleas F, Pedersen T, Bjornara B, Dalene F, Kleveland G, Schepel J, Olsen IC, Myhr KM. omega-3 fatty acid treatment in multiple sclerosis (OFAMS Study): a randomized, double-blind, placebo-controlled trial. Arch Neurol. 2012 Aug;69(8):1044-51. doi: 10.1001/archneurol.2012.283.
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 kwietnia 2015
Zakończenie podstawowe (Rzeczywisty)
1 września 2016
Ukończenie studiów (Rzeczywisty)
1 października 2016
Daty rejestracji na studia
Pierwszy przesłany
14 października 2016
Pierwszy przesłany, który spełnia kryteria kontroli jakości
17 października 2016
Pierwszy wysłany (Oszacować)
19 października 2016
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
14 maja 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
23 kwietnia 2019
Ostatnia weryfikacja
1 kwietnia 2019
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Procesy patologiczne
- Choroby Układu Nerwowego
- Choroby układu odpornościowego
- Demielinizacyjne choroby autoimmunologiczne, OUN
- Choroby Autoimmunologiczne Układu Nerwowego
- Choroby demielinizacyjne
- Choroby Autoimmunologiczne
- Stwardnienie rozsiane
- Skleroza
- Stwardnienie rozsiane, rzutowo-remisyjne
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Środki immunosupresyjne
- Czynniki immunologiczne
- Sfingozyna 1 Modulatory receptora fosforanowego
- Chlorowodorek fingolimodu
Inne numery identyfikacyjne badania
- 293396
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Niezdecydowany
Opis planu IPD
The investigators may make individual participant data available regarding drug side effects or other factors that need to be described individually however the primary outcome will be published as group result and not individual results.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
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 .