Epilepsy, a condition where individuals are prone to recurrent epileptic seizures, is the
most common chronic neurological disorder in children. Epilepsy onset is most common in the
first two years of life and is associated with poor prognosis for seizure control and
neurodevelopmental outcome.
The ketogenic diet (KD) is a medically supervised diet that is high in fat and restricted in
carbohydrates and protein. KD therapy has shown to be an effective treatment for seizures in
children with epilepsy older than two. Associated benefits include: a reduced requirement for
routine and emergency antiepileptic drugs (AED) and fewer seizure related hospital
admissions. Although reports suggest that KD therapy improves seizures in younger children
there is no high quality trial data that demonstrates effectiveness and safety in this age
group. The KD is resource intensive, requiring dietetic and physician time; data is required
to justify expansion of services to cater for the apparent need.
The investigators therefore propose a prospective multicentre randomised trial to investigate
the effectiveness and safety of the KD in children with epilepsy under the age of 2, who have
failed to respond to two or more AEDs. Children will be randomly assigned to either receive
the KD or further AEDs. The allocated treatment will be started after a 2week baseline
period, and it's effectiveness assessed after 8 weeks. Seizure diaries will be used to record
seizures and related events, a questionnaire will be used to assess diet tolerance; also
growth and blood biochemistry will be monitored.
The information obtained from this study is necessary to optimise choices in epilepsy
treatment, aiming to improve outcomes and thus determine whether and when the KD should
should be used.
Phase:
Phase 4
Details
Lead Sponsor:
University College, London
Collaborators:
Alder Hey Children's NHS Foundation Trust Birmingham Children's Hospital NHS Foundation Trust Birmingham Women's and Children's NHS Foundation Trust Bristol Royal Hospital for Children Cambridge University Hospitals NHS Foundation Trust Central Manchester University Hospitals NHS Foundation Trust Great Ormond Street Hospital for Children NHS Foundation Trust Guy's and St Thomas' NHS Foundation Trust Lancashire Care NHS Foundation Trust Manchester University NHS Foundation Trust Matthew's Friends National Institute for Health Research, United Kingdom Newcastle-upon-Tyne Hospitals NHS Trust Sheffield Children's NHS Foundation Trust St George's University Hospitals NHS Foundation Trust The Leeds Teaching Hospitals NHS Trust