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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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24 May 2021 |
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Main ID: |
ISRCTN57643242 |
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Date of registration:
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20/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Omega 3 fatty acid treatment in patients with epilepsy
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Scientific title:
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Omega 3 fatty acid supplementation to prevent seizure in patients with refractory epilepsy |
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Date of first enrolment:
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01/09/2014 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN57643242 |
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Study type:
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Interventional |
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Study design:
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Double-blind placebo-controlled randomised intervention trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Sudan
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Contacts
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Name:
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Kebreab
Ghebremeskel |
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Address:
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Lipidomics and Nutrition Research Centre
Faculty of Life Sciences and Computing
London Metropolitan University
166-220 Holloway Road
N7 8DB
London
United Kingdom |
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Telephone:
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- |
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Email:
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k.ghebremeskel@londonmet.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with refractory idiopathic epilepsy, aged 17 to 50 years
Exclusion criteria:
1. Age under 17 and over 50 years
2. Other diseases in addition to epilepsy
3. Structural lesions
4. Pregnancy
5. Responsive to AED
6. Less than two seizures a month
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epilepsy
Nervous System Diseases
Epilepsy
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Intervention(s)
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1. Active supplement (contains 1.5g DHA and 390mg EPA)
2. Placebo (1.9g of saturated and monounsaturated fatty acid blend)
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Primary Outcome(s)
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Complete elimination or reduction in the frequency seizures
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Secondary Outcome(s)
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1. Improvements of cognition, memory, and manifestations of behavioural and psychiatric disorders 2. Modulation of clinical markers of cardiac arrhythmias; down regulation of inflammatory markers
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Secondary ID(s)
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EPILOEMGA3 v1
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Source(s) of Monetary Support
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Lipidomics and Nutrition Research Centre, London Metropolitan University, London (UK), University of Khartoum Hospital (Sudan), Efamol Limited (UK)
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Ethics review
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Status:
Approval date:
Contact:
Research Ethics Committee of the Faculty of Medicine, University of Khartoum, Sudan, 26/11/2012
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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28/02/2017 |
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URL:
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