Condition category
Nervous System Diseases
Date applied
13/05/2014
Date assigned
20/08/2014
Last edited
01/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kebreab Ghebremeskel

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EPILOEMGA3 v1

Study information

Scientific title

Omega 3 fatty acid supplementation to prevent seizure in patients with refractory epilepsy

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

Research Ethics Committee of the Faculty of Medicine, University of Khartoum, Sudan, 26/11/2012

Study design

Double-blind placebo-controlled randomised intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/09/2014

Overall trial end date

28/02/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with refractory idiopathic epilepsy, aged 17 to 50 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

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

Sudan

Trial participating centre

London Metropolitan University
London
N7 8DB
United Kingdom

Sponsor information

Organisation

Faculty of Life Sciences and Computing, London Metropolitan University (UK)

Sponsor details

166-220 Holloway Road
London
N7 8DB
United Kingdom
-
d.palmer-brown@londonmet.ac.uk

Sponsor type

University/education

Website

http://www.londonmet.ac.uk

Funders

Funder type

University/education

Funder name

Lipidomics and Nutrition Research Centre, London Metropolitan University, London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Khartoum Hospital (Sudan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Efamol Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/04/2016: Ethics approval information added.