Multiple Sclerosis Clinical Trial
Official title:
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.
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.
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