Omega 3 fatty acid treatment in patients with epilepsy
| ISRCTN | ISRCTN57643242 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57643242 |
| Secondary identifying numbers | EPILOEMGA3 v1 |
- Submission date
- 13/05/2014
- Registration date
- 20/08/2014
- Last edited
- 10/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Eating foods rich in omega 3 fatty acids, EPA and DHA is considered to be very good for us. There is a lot of evidence to suggest they help prevent a number of diseases, including cardiovascular (for example heart) disease and neurological (for example brain) disease as well as maintain the normal functioning of both the heart and the brain. It is also thought that they may help in reducing drug-induced toxicity and boosting how well a drug works against a disease. It is possible that omega 3 fatty acids will help patients with epilepsy by reducing the number of seizures that they have and by making those that they do have, less severe. It is also thought that they may prevent the cardiac arrhythmia (irregular beating of the heart) and sudden unexpected death that can happen after a seizure and help control the psychological effects of the disease. As there is evidence that seizures may result in inflammation, epileptic patients may also benefit from the anti-inflammatory effects of omega 3 fatty acids. Here, we will investigate how omega 3 fatty acids may help to prevent patients with difficult to treat epilepsy for which there is no known cause (refractory idiopathic epilepsy) from having seizures and reduce the possibility of dying from them.
Who can participate?
Patients with refractory idiopathic epilepsy, aged 17 to 50 years.
What does the study involve?
Patients are randomly allocated into one of two groups. Those in group 1 are asked to take an omega 3 supplement contains 1.5g DHA and 390mg EPA for one year. Those in group 2 take a placebo (dummy pill). Blood samples are collected from all participants at the start and end of the trial for analysis. Clinical history, neurological and psychological/psychiatric assessments are also carried out at the start and end of the trial.
What are the possible benefits and risks of participating?
Each participant will receive a close monitoring throughout the study duration. There is no risk to participating.
Where is the study run from?
The study has been set up by the Lipidomics and Nutrition Research Centre, Faculty of Life Sciences and Computing, London Metropolitan University (UK) in collaboration with the University of Khartoum Hospital, Khartoum (Sudan).
When is study starting and how long is it expected to run for?
September 2014 to February 2017
Who is funding the study?
Lipidomics and Nutrition Research Centre, London (UK)
University of Khartoum Hospital (Sudan)
Efamol Limited (UK)
Who is the main contact?
Professor Kebreab Ghebremeskel,
k.ghebremeskel@londonmet.ac.uk OR keb@kebgm.demon.co.uk
Contact information
Scientific
Lipidomics and Nutrition Research Centre
Faculty of Life Sciences and Computing
London Metropolitan University
166-220 Holloway Road
London
N7 8DB
United Kingdom
| k.ghebremeskel@londonmet.ac.uk |
Study information
| Study design | Double-blind placebo-controlled randomised intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Omega 3 fatty acid supplementation to prevent seizure in patients with refractory epilepsy |
| Study acronym | EPILOMEGA3 |
| Study hypothesis | 1. Core null hypothesis: Patients with refractory epilepsy do not have abnormal plasma and blood cell fatty acids; Supplementation with the long-chain polyunsaturated omega 3 fatty acids, EPA and DHA, will not prevent seizures in patients with refractory epilepsy. 2. Subsidiary null hypothesis: Refractory epileptics supplemented with EPA and DHA will not have enhanced mental performance, cognition and memory. 3. Nested null hypotheses: Treatment of refractory epileptic patients with EPA and DHA will not improve behavioural and psychiatric disorders; modulate clinical markers of cardiac arrhythmias; down-regulate inflammatory markers. |
| Ethics approval(s) | Research Ethics Committee of the Faculty of Medicine, University of Khartoum, Sudan, 26/11/2012 |
| Condition | Epilepsy |
| Intervention | 1. Active supplement (contains 1.5g DHA and 390mg EPA) 2. Placebo (1.9g of saturated and monounsaturated fatty acid blend) |
| Intervention type | Supplement |
| Primary outcome measure | Complete elimination or reduction in the frequency seizures |
| Secondary outcome measures | 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 |
| Overall study start date | 01/09/2014 |
| Overall study end date | 28/02/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 99 |
| Participant inclusion criteria | Patients with refractory idiopathic epilepsy, aged 17 to 50 years |
| Participant 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 |
| Recruitment start date | 01/09/2014 |
| Recruitment end date | 28/02/2017 |
Locations
Countries of recruitment
- England
- Sudan
- United Kingdom
Study participating centre
N7 8DB
United Kingdom
Sponsor information
University/education
166-220 Holloway Road
London
N7 8DB
England
United Kingdom
| d.palmer-brown@londonmet.ac.uk | |
| Website | http://www.londonmet.ac.uk |
"ROR" |
https://ror.org/00ae33288 |
Funders
Funder type
University/education
No information available
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/10/2018 | 10/05/2021 | Yes | No |
Editorial Notes
10/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
01/04/2016: Ethics approval information added.
