Double-blind parallel study of Omega-3 fatty acid supplement in patients with refractory epilepsy

ISRCTN	ISRCTN14235435
DOI	https://doi.org/10.1186/ISRCTN14235435
Protocol serial number	N0263120045
Sponsor	Department of Health (UK)
Funders	University College London Hospitals NHS Trust (UK), National Society for Epilepsy (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M Koepp
Scientific

Clinical Neurology
National Hospital for Neurology/Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom

Phone	+44 (0)20 7837 3611

Primary study design	Interventional
Study design	Double blind parallel randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To assess the effect of Omega-3 supplementation on seizure frequency in patients with refractory epilepsy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nervous System Diseases: Epilepsy
Intervention	1. Omega-3 fatty acid 2. Olive oil
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Omega-3 fatty acid and olive oil
Primary outcome measure(s)	Seizure frequency and adverse events
Key secondary outcome measure(s)	1. Antiepileptic drug (AED) levels 2. Patients' global impression 3. Behaviour and mood probes 4. Hamilton Depression rating scale 5 Plasma and red blood cell (RBC) fatty acid concentrations 6. Magnetic resonance (MR) spectroscopic measurement of phosphomonoester and phosphodiester 6. Changes in total brain volume
Completion date	01/08/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	52
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/02/2003
Date of final enrolment	01/08/2005

Clinical Neurology

London
WC1N 3BG
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2005		Yes	No