It has been shown that administration of fatty acids to laboratory animals reduces seizure frequency but there is not enough information in humans and especially in children.The objective of this study was to investigate the efficacy of Omega 3 in children with refractory epilepsy. This randomized crossover open label non placebo controlled phase 3 clinical trial was conducted in two medical centers in two three month periods. Subjects of the study were children (2-13 years old) who referred to neurology outpatient clinics of the two medical centers and were diagnosed with refractory epilepsy by a pediatric neurologist.The inclusion criteria consisted of presence of at least 4 convulsions per month which were not controlled by at least 3 different anti-epileptic medications.The exclusion criterion was allergy to the fish oil.The subjects were randomly divided into two groups.The first group received 1.5 grams/m2 of Omega 3 in a single daily dose for the first three months in addition to their routine anti-epileptic medications.The second group only received their routine anti-epileptic medications.At the end of three month period, each group underwent a one month washout period and then got crossed over with respect to treatment. Parents were asked to report their observations of frequency and severity of seizures in specific forms designed by the investigators.At the end of each three month period, the researchers reviewed daily logs provided by the parents and the average number and severity of seizures were measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012115365N1
Registration date:2011-08-08, 1390/05/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-08, 1390/05/17
Registrant information
Name
Hamed Azarnoush
Name of organization / entity
Islamic Azad university of Najafabad
Country
Iran (Islamic Republic of)
Phone
+98 33 1229 1111
Email address
hamedmds@smd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad University of Medical Sciences Najafabad Branch
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of omega 3 fatty acid supplementation in children with refractory epilepsy refer to selected Isfahan's hospitals 1389
Public title
Assess the effectiveness of omega 3 on children with refractory epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
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)
Age
From 2 years old to 13 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjrib street
City
Isfahan
Postal code
81745-319
Approval date
2011-07-12, 1390/04/21
Ethics committee reference number
490001
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40.1,G40.
ICD-10 code description
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
Primary outcomes
1
Description
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
2
Description
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
Secondary outcomes
1
Description
other benefits of omega3
Timepoint
after three month period of receiving omega 3
Method of measurement
interview
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Dr Mohammadreza Ghazavi
Street address
Al Zahra Hospital, Soffeh street, Hakimnezami junction
City
Isfahan
2
Recruitment center
Name of recruitment center
Dr Shariati Hospital
Full name of responsible person
Dr. Hamed Azarnoush
Street address
Dr Shariati Hospital, Chaharbagh bala street, Darvaze Shiraz square
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University of Medical Sciences Najafabad Branch
Full name of responsible person
Dr.Reza Ebrahimi
Street address
Islamic Azad University of Najafabad, Daneshgah blvd
City
Najafabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Islamic Azad University of Medical Sciences Najafabad Branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University of Najafabad
Full name of responsible person
Dr. Hamed Azarnoush
Position
Intern-Medical student
Other areas of specialty/work
Street address
Islamic Azad University of Najafabad, Daneshgah blvd
City
Najafabad
Postal code
517
Phone
+98 33 1229 1111
Fax
+98 31 1630 2998
Email
hamedmds@yahoo.com, hamedmds@gmail.com
Web page address
www.iaun.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Saadatnia
Position
Neurologist
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjrib street
City
Isfahan
Postal code
Phone
+98 31 1668 0048
Fax
+98 31 1668 5145
Email
saadatnia@med.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Najafabad
Full name of responsible person
Dr. Hamed Azarnoush
Position
Intern-medical student
Other areas of specialty/work
Street address
Islamic Azad University of Najafabad, Daneshgah blvd
City
Najafabad
Postal code
517
Phone
+98 33 1229 1111
Fax
+98 31 1630 2998
Email
hamedmds@yahoo.com, hamedmds@smd.iaun.ac.ir
Web page address
www.iaun.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)