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IRCT201012115365N1 IRCT 2011-08-08 Vice chancellor for research, Islamic Azad University of Medical Sciences Najafabad Branch Assess the effectiveness of omega 3 on children with refractory epilepsy Efficacy of omega 3 fatty acid supplementation in children with refractory epilepsy refer to selected Isfahan's hospitals 1389 2010-07-23 anticipated 46 Complete https://irct.ir/trial/5762 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment. 3 Epilepsy. Intervention 1: Group 1:In the first three months group 1 received 1.5 grams/m2 of Omega 3 in a single daily dose in addition to their routine anti-epileptic medications.Each 5 ml of the Omega 3 contained 1.484 mg of omega 3, 786 mg of EPA and 524 mg of DHA.After one month washout period this group received only their routine anti-epileptic medications for another three months.During the study period, the-anti epileptic medication or its dosage could be changed if investigators determined a need for this change. Intervention 2: Group 2: In the first three months group 2 received only their routine anti-epileptic medications. For the second three month this group received 1.5 grams/m2 of Omega 3 in a single daily dose in addition to their routine anti-epileptic medications.Each ml of the Omega 3 contained 1.484 mg of omega 3, 786 mg of EPA and 524 mg of DHA. During the study period, the-anti epileptic medication or its dosage could be changed if investigators determined a need for this change.
public Dr. Hamed Azarnoush
Islamic Azad University of Najafabad, Daneshgah blvd
Najafabad Iran (Islamic Republic of) 517 +98 33 1229 1111 hamedmds@yahoo.com, hamedmds@gmail.com Islamic Azad University of Najafabad scientific Dr. Mohammad Saadatnia
Isfahan University of Medical Sciences, Hezarjrib street
Isfahan Iran (Islamic Republic of) +98 31 1668 0048 saadatnia@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion Criteria:lack of neurodegenerative disorder; lack of neurometabolic disorder; Insufficient control of epilepsy by at least 3 anti epileptic medications; More than 4 seizure episodes per month. Exclusion Criteria: exhibit frequent vomiting; inability to swallow; an allergy to fish oil; subjects taking high doses of aspirin (>325mg daily) 2 years 13 years Both G40.1,G40. Localization-related (focal)(partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset Benign childhood epilepsy with centrotemporal EEG spikes Childhood epilepsy with occipital EEG paroxysms G40.1 Localization-related (foca Treatment - Drugs Treatment - Drugs Group 1:In the first three months group 1 received 1.5 grams/m2 of Omega 3 in a single daily dose in addition to their routine anti-epileptic medications.Each 5 ml of the Omega 3 contained 1.484 mg of omega 3, 786 mg of EPA and 524 mg of DHA.After one month washout period this group received only their routine anti-epileptic medications for another three months.During the study period, the-anti epileptic medication or its dosage could be changed if investigators determined a need for this change. Group 2: In the first three months group 2 received only their routine anti-epileptic medications. For the second three month this group received 1.5 grams/m2 of Omega 3 in a single daily dose in addition to their routine anti-epileptic medications.Each ml of the Omega 3 contained 1.484 mg of omega 3, 786 mg of EPA and 524 mg of DHA. During the study period, the-anti epileptic medication or its dosage could be changed if investigators determined a need for this change. Frequency of seizures. Timepoint: baseline; after first three month period; after second three month period. Method of measurement: Average of seizure episodes at the end of each three month period. Severity of seizure. Timepoint: baseline; after first three month period; after second three month period. Method of measurement: scale of 1 - 10, scored by parents. Other benefits of omega3. Timepoint: after three month period of receiving omega 3. Method of measurement: interview. Vice chancellor for research, Islamic Azad University of Medical Sciences Najafabad Branch Approved 2011-07-12 Ethics commitee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezarjrib street Isfahan Iran (Islamic Republic of)