Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study evaluates the effect of adding fish oil to Fingolimod on some serum cytokines in
      patients with Relapsing-Remitting Multiple Sclerosis.
    

Detailed description: 
      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.
    

Intervention name(s): Fingolimod; Fish Oil; Placebo (for Fish Oil)
Intervention type(s): Drug; Dietary Supplement; Drug
Intervention description(s): Produced by Osveh ® Pharm Company in Iran; produced by Zahravi ® Pharm Company in Iran; placebo capsules to mimic Fish Oil 1 g capsules
Other intervention name(s): Fingolid ®; CODLIVE ®; OMEGAMAX ®
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Fingolimod; Fish Oil