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Trial record 61 of 1572 for:    epilepsy

Ketogenic Diet in Infants With Epilepsy (KIWE) (KIWE)

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ClinicalTrials.gov Identifier: NCT02205931
Recruitment Status : Recruiting
First Posted : August 1, 2014
Last Update Posted : May 4, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Other Names:
  • Carbamazepine
  • Clobazam
  • Clonazepam
  • Ethosuximide
  • Lacosmide
  • Lamotrigine
  • Levetiracetam
  • Nitrazepam
  • Phenytoin
  • Rufinamide
  • Sodium Valproate
  • Stiripentol
  • Topiramate
  • Vigabatrin
  • Zonisamide


Outcome Measures

Primary Outcome Measures :
  1. Number of seizures [ Time Frame: 6 - 8 weeks ]
    Number of seizures experienced during weeks 6 - 8


Secondary Outcome Measures :
  1. Responder rate [ Time Frame: 8 weeks ]
    number of children seizure free and relationship between medium chain fatty acids and seizure control


Other Outcome Measures:
  1. Retention on treatment [ Time Frame: 12 months ]
    retention on treatment, quality of life and neurodevelopmental outcome


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 1 month and 24 months of age (not beyond second birthday at baseline).
  2. Diagnosis of epilepsy confirmed.
  3. At least an average of 4 seizures/week in baseline period.
  4. Failed response to previous trial of two anti-epileptic drugs. In the case of infantile spasms this could include a trial of corticosteroids.
  5. Children with written informed consent from parent/guardian.

Exclusion Criteria:

  1. Age <1m or > 24 months of age
  2. No secure diagnosis of epilepsy
  3. < 4 seizures/week on average in baseline period
  4. Trial of < 2 AEDs
  5. Continues on corticosteroids in previous 3 months prior to randomisation
  6. Metabolic disease contraindicating use of the ketogenic diet e.g. pyruvate carboxylase deficiency, MCAD from previous medical investigation and screening at baseline.
  7. Progressive neurological disease
  8. Severe gastroesophageal reflux
  9. Previous treatment with the ketogenic diet
  10. Concurrent participation in another clinical trial of an investigational medicinal product.
  11. Patients who are prescribed AEDs not listed in the trial IMPs
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Helen Cross, FRCP(UK) 0044 207 599 4105 h.cross@ucl.ac.uk
Contact: Siobhan Titre-Johnson, MSc s.titre-johnson@ucl.ac.uk

Locations
United Kingdom
Birmingham Children's Hospital Recruiting
Birmingham, United Kingdom, B4 6NH
Contact: Shakti Agrawal, MBBS    0044 1213338149    shakti.agrawal@bch.nhs.uk   
Principal Investigator: Shakti Agrawal, MBBS         
Bristol Royal Hospital for Children Recruiting
Bristol, United Kingdom, BS2 8AE
Contact: Andrew Mallick, FRCPCH         
Principal Investigator: Andrew Mallick         
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Alasdair Parker, MA    0044 1223 245151    alasdair.parker@addenbrookes.nhs.uk   
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    h.mccullagh@nhs.net   
Principal Investigator: Helen McCullagh, RCPCH         
Alder Hey Children's Hospital Recruiting
Liverpool, United Kingdom, L12 2AP
Contact: Rachel Kneen, BMBS    0044 151 2525163    rachel.kneen@liverpool.ac.uk   
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    christin.eltze@gosh.nhs.uk   
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    timothy.martland@cmft.nhs.uk   
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         
Sponsors and Collaborators
University College, London
Great Ormond Street Hospital for Children NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Alder Hey Children's NHS Foundation Trust
Bristol Royal Hospital for Children
Birmingham Women's and Children's NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
Central Manchester University Hospitals NHS Foundation Trust
Sheffield Children's NHS Foundation Trust
National Institute for Health Research, United Kingdom
Lancashire Care NHS Foundation Trust
Newcastle-upon-Tyne Hospitals NHS Trust
St George's University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Helen Cross, FRCP(UK) UCL Institute of Child Health
More Information

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02205931     History of Changes
Other Study ID Numbers: 13/0656
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by University College, London:
Epilepsy
Ketogenic diet
Antiepileptic drugs
Randomised controlled trial

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Carbamazepine
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action