Ketogenic Diet in Infants With Epilepsy (KIWE)

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

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
• Treatments: Anticonvulsants; Carbamazepine; Clobazam; Clonazepam; Ethosuximide; Lamotrigine; Levetiracetam; Nitrazepam; Phenytoin; Rufinamide; Stiripentol; Topiramate; Valproic Acid; Vigabatrin; Zonisamide

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