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Ketogenic Diet in Infancy (KIWE)

 

 

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The Ketogenic Diet in Infancy (KIWE) trial

KIWE is a multicentre randomised trial to investigate the effectiveness and safety of the ketogenic diet in children with epilepsy under the age of 2 years, who have failed to respond to two or more anti-epileptic drugs. 
 

About Us

We are interested in determining the effectiveness on seizure control of the ketogenic diet (KD) compared to further anti-epileptic drug (AED) treatment in children with epilepsy aged 1 month to 2 years who have failed to respond to two or more pharmacological treatments.

Why do we need to study children presenting with epilepsy?

Epilepsy, a condition where individuals are prone to recurrent epileptic seizures, is the most common chronic neurological disorder in children.  Currently, the first line management for children presenting with epilepsy is antiepileptic medication. There are currently guidelines which exist on which drugs to use, however, management is still based on a somewhat 'trial and error approach'.

Why do we need to study this age range?

Epilepsy onset is most common in the first 2 years of life and at this age is particularly associated with poor prognosis for seizure control and neurodevelopmental outcome.

What is the ketogenic diet? 

The ketogenic diet (KD) is a medically supervised dietary intervention that is high in fat and restricted in carbohydrate and protein, designed to mimic the effects of starvation on the body. KD therapy has been shown to be an effective treatment for seizure control in children with epilepsy older than 2 years of age.

KIWE is, therefore, an important trial to optimise choices in epilepsy treatment, aiming to improve outcomes and thus determine whether and when the KD should be considered in this young age group. We are in an excellent position to lead this trial having successfully conducted the first randomised trial investigating KD in older children at Great Ormond Street Hospital.

The trial is supported by Priment CTU

Who can join?

Main inclusion criteria

Children aged between 1 months and 24 months of age (not beyond second birthday at baseline) with a confirmed diagnosis of epilepsy

 

Main exclusion criteria

  • Metabolic disease contraindicating use of the ketogenic diet
  • Progressive neurological disease
  • Severe gastroesophageal reflux
  • Previous treatement with the ketogenic diet
  • At least an average of 4 seizures/week
  • Failed response to at least two anti-epileptic drugs
Trial Design

Children for this study will be recruited from 12 paediatric neurology centres in England who have an established KD service. After baseline assessment and one/two week observation period, children will be randomly assigned to either receive the ketogenic diet or a further anti-epileptic drug. The allocated treatment will be started and it's effectiveness assessed after 8 weeks of treatment. 

Standardised seizure diaries will be used to record seizures and related events, questionnaires will be used to assess tolerability of treatment, quality of life and
neurodevelopment, and growth and blood biochemistry will be monitored.

Trial Design Flowchart 
AClinical assessment including weight, length, head circumference, general examination
BBlood evaluation including for full blood count, liver function tests, renal function, calcium, urate, glucose, phosphate, β hydroxbutyrate & acetoacetate, vitamin D, selenium, zinc, cholesterol and carnitine profile (KD)
CIssue/collect seizure diaries
DAdminister side effects questionnaire (KD)
ETelephone or clinical review
FInfant Toddler Quality of Life questionnaire
GVineland Adaptive Behaviour questionnaire
HSeizure recording must be captured daily 28 days before 12  month review

 

Meet the team

KIWE Chief Investigator

Professor Helen Cross

KIWE Trial Manager:

Laura Lyons

KIWE Trial Assistant

Maryam Balogun

We are currently recruiting at the following centres:

Great Ormond Street Hospital (Dr Christin Eltze)

Bristol Royal Hospital For Children (Dr Andrew Mallick)

St George's University Hospitals NHS Foundation Trust (Dr Penny Fallon)

Leeds Teaching Hospital NHS Trust (Dr Helen McCullagh)

Alder Hey Children's Hospital (Dr Rachel Kneen)

Royal Manchester Children's Hospital (Dr Tim Martland)

Addenbrookes NHS Trust (Dr Alasdair Parker)

Birmingham Children's Hospital (Dr Shakti Agrawal)

Sheffield Teaching Hospitals NHS Foundation Trust (Dr Archana Desurkar)

Royal Preston Hospital (Dr Helen Basu)

The Great North Children's Hospital (Dr Anita Devlin)

Leicester Royal Infirmary (Dr Rajib Samanta)

Participant identification centres:

University Hospital Southampton NHS Foundation Trust (Dr Andrea Whitney)

Latest News

We are pleased to welcome 4 new recruiting centres to the KIWE trial

Sheffield Teaching Hospitals NHS Foundation Trust (Dr Archana Desurkar)

Royal Preston Hospital (Dr Helen Basu)

The Great North Children's Hospital (Dr Anita Devlin)

Leicester Royal Infirmary (Dr Rajib Samanta)

Contact Us

If you would like to find out more about the study, please contact Laura Lyons (KIWE trial manager) or Maryam Balogun (KIWE trial assistant) on 020 7905 2968 or by email at laura.lyons@ucl.ac.uk  / maryam.balogun.17@ucl.ac.uk

Postal address:

Developmental Neurosciences

UCL GOS Institute of Child Health

30 Guilford Street

London WC1N 1EH