Effect of omega-3 versus placebo on the clinical and paraclinical situation in patients with refractory epilepsy: a triple blind randomized clinical trial

Objectives: To assess the effect of omega-3 versus placebo on the clinical and paraclinical situation in patients with refractory epilepsy. Design: a triple blind randomized clinical trial. Setting and conduct: The eligible patients with refractory epilepsy who will refer to farshchian Hospital during the study period will be enrolled into the trial. Inclusion criteria: (a) age of 18 to 55 years; (b) having refractory epilepsy. Exclusion criteria: (a) pregnancy or breastfeeding; (b) having underling diseases such as lever disease, kidney disease, active infection, pulmonary disease, hypertension, dementia, and mental retardation; (c) catamenial epilepsy. Intervention group: Routine treatment plus oral omega-3 one tablet 1000 mg twice a day for 4 months. Control group: Routine treatment plus a placebo tablet twice a day for 4 months. Primary outcome: Assessing the frequency of seizures before treatment and every month for 4 months by taking history. Secondary outcome: (a) assessing serum level of interleukin-6 before treatment and 4 months later by laboratory test; (b) assessing serum level of TNF-α before treatment and 4 months later by laboratory test; (c) assessing electroencephalogram changes before treatment and 4 months later by taking electroencephalogram. Randomization: The patients will be randomly assigned to intervention and control groups using block randomization of six. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.

Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences