Ketogenic Diet in Infants With Epilepsy (KIWE) (KIWE)
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|ClinicalTrials.gov Identifier: NCT02205931|
Recruitment Status : Unknown
Verified May 2017 by University College, London.
Recruitment status was: Recruiting
First Posted : August 1, 2014
Last Update Posted : May 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Other: Ketogenic diet Drug: Antiepileptic drug therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomised Controlled Trial of the Ketogenic Diet in the Treatment of Epilepsy in Children Under the Age of Two Years|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2019|
Experimental: Ketogenic diet
8 week trial of the ketogenic diet (KD) therapy. Children allocated to KD therapy will have their diets individually calculated by a paediatric dietitian with consideration of daily calorie requirements, adequate protein intake for growth and vitamin and mineral supplementation. All diets will be implemented according to a classical KD protocol, i.e. based on a ratio of fat to carbohydrate and protein that will usually be between 2:1 and 4:1.
Other: Ketogenic diet
The ketogenic diet is a high fat diet designed to mimic the effects on the body of starvation. The premise is the main energy intake is fat, which is utilised in the body and produces ketones.
Active Comparator: Antiepileptic drug therapy
The control intervention will be drug therapy with the most appropriate further antiepileptic drug (AED) for a particular child, depending on their presenting seizures and syndrome and previous drugs used, and chosen by the expert clinician responsible for management of the patient's epilepsy according to a standardised manual (consensus document) written following the initial workshop of the paediatric neurologists from all the trial centres.
Drug: Antiepileptic drug therapy
The control intervention will be drug therapy with the most appropriate further antiepileptic drug for a particular child, depending on their presenting seizures and syndrome and previous drugs used, and chosen by the expert clinician responsible for management of the patient's epilepsy.
- Number of seizures [ Time Frame: 6 - 8 weeks ]Number of seizures experienced during weeks 6 - 8
- Responder rate [ Time Frame: 8 weeks ]number of children seizure free and relationship between medium chain fatty acids and seizure control
- Retention on treatment [ Time Frame: 12 months ]retention on treatment, quality of life and neurodevelopmental outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205931
|Contact: Helen Cross, FRCP(UK)||0044 207 599 firstname.lastname@example.org|
|Contact: Siobhan Titre-Johnson, MScemail@example.com|
|Birmingham Children's Hospital||Recruiting|
|Birmingham, United Kingdom, B4 6NH|
|Contact: Shakti Agrawal, MBBS 0044 1213338149 firstname.lastname@example.org|
|Principal Investigator: Shakti Agrawal, MBBS|
|Bristol Royal Hospital for Children||Recruiting|
|Bristol, United Kingdom, BS2 8AE|
|Contact: Andrew Mallick, FRCPCH|
|Principal Investigator: Andrew Mallick|
|Cambridge, United Kingdom, CB2 0QQ|
|Contact: Alasdair Parker, MA 0044 1223 245151 email@example.com|
|Principal Investigator: Alasdair Parker, MA|
|Lancashire Teaching Hospitals NHS Foundation Trust||Recruiting|
|Lancashire, United Kingdom|
|Contact: Helen Basu Helen.Basu@lthtr.nhs.uk|
|Principal Investigator: Helen Basu|
|Leeds Teaching Hospital||Recruiting|
|Leeds, United Kingdom, LS1 3EX|
|Contact: Helen McCullagh, RCPCH 0044 113 243 2799 firstname.lastname@example.org|
|Principal Investigator: Helen McCullagh, RCPCH|
|Alder Hey Children's Hospital||Recruiting|
|Liverpool, United Kingdom, L12 2AP|
|Contact: Rachel Kneen, BMBS 0044 151 2525163 email@example.com|
|Principal Investigator: Rachel Kneen, BMBS|
|Great Ormond Street Hospital||Recruiting|
|London, United Kingdom, WC1N 3JH|
|Contact: Christin Eltze, MD Res 0044 207 405 9200 ext 5438 firstname.lastname@example.org|
|Principal Investigator: Christin Eltze, MD Res|
|St George's University Hospitals NHS Foundation Trust||Recruiting|
|London, United Kingdom|
|Contact: Penny Fallon Penny.Fallon@stgeorges.nhs.uk|
|Principal Investigator: Penny Fallon|
|Royal Manchester Children's Hospital||Recruiting|
|Manchester, United Kingdom, M13 0JE|
|Contact: Tim Martland, RCPCH 0044 161 276 1234 email@example.com|
|Principal Investigator: Tim Martland, RCPCH|
|The Newcastle Upon Tyne Hospitals NHS Foundation Trust||Recruiting|
|Newcastle upon Tyne, United Kingdom|
|Contact: Anita Devlin Anita.Devlin@nuth.nhs.uk|
|Principal Investigator: Anita Devlin|
|Sheffield Children's NHS Foundation Trust||Recruiting|
|Sheffield, United Kingdom|
|Contact: Archana Desurkar Archana.Desurkar@sch.nhs.uk|
|Principal Investigator: Archana Desurkar|
|Principal Investigator:||Helen Cross, FRCP(UK)||UCL Institute of Child Health|