Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients
Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients
This study evaluates the effect of adding fish oil to Fingolimod on some serum cytokines in
 patients with Relapsing-Remitting Multiple Sclerosis.
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.
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