epilepsy or seizure attacks
Conditions
Interventions
Description of the ketogenic diet:
The ketogenic diet is introduced during a hospitalization for one week or
longer if medically indicated. The diet is calculated on an individual basis
by the dieti
Sponsors
Epilepsiecentrum Kempenhaeghe
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: Male and female children with uncontrolled seizures, aged between 1-18 years who are not eligible for epilepsy surgery.
Exclusion criteria
Exclusion criteria: The following medical contraindications of the ketogenic diet are criteria for exclusion: • Fatty acid oxidation disorders and related diseases • Diabetes and hyperinsulinism • Prolonged QT-time syndrome • Hypercholesterolemia, hypertriglyceridemia • Severe liver, kidney or pancreas diseases • Renal tubular acidosis • Treatment with topiramate or acetazolamide and a positive family history or other risk factors for kidney stones or acidosis • Severe behavioural disorder • Malnutrition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical outcome: proportion of children with a 50% or more reduction in seizure frequency. Economic evaluation: • Quality of life and quality adjusted life years (QALYs). • Societal costs | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary parameters are: • Mean number of seizures as a percentage of the number of seizures during the 4-week baseline period. • Seizure severity: National Hospital Seizure Severity Scale (NHS3). • Side effects/complaints: Side Effects of Anti-Epileptic Drugs questionnaire (SIDEAD). • Psychological assessment : o Cognition o Behavioural and social-emotional functioning o Psychosocial adjustment | — |
Countries
Netherlands
Outcome results
None listed