Double-blind parallel study of Omega-3 fatty acid supplement in patients with refractory epilepsy
| ISRCTN | ISRCTN14235435 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14235435 |
| Secondary identifying numbers | N0263120045 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 28/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M Koepp
Scientific
Scientific
Clinical Neurology
National Hospital for Neurology/Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom
| Phone | +44 (0)20 7837 3611 |
|---|
Study information
| Study design | Double blind parallel randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Omega-3 fatty acid and olive oil |
| Primary outcome measure | Seizure frequency and adverse events |
| Secondary outcome measures | 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 |
| Overall study start date | 01/02/2003 |
| Completion date | 01/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 52 patients from Epilepsy Department |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Neurology
London
WC1N 3BG
United Kingdom
WC1N 3BG
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Charity
University College London Hospitals NHS Trust (UK)
No information available
National Society for Epilepsy (UK)
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 | results | 01/09/2005 | Yes | No |
