childhood epilepsy refractory epilepsy
Conditions
Interventions
Replacement of the usual formula into Ketocal Infant formula and therefore
changing from carbohydrate to fat burning for energy supply. This results in
state of ketosis which can influence the seizu
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Infant aged 0-24 clinical indication for use of the ketogenic diet for either treatment of epilepsy or disorder of carbohydrate metabolism responsive to the ketogenic diet will take the majority of prescribed calorie intake from Ketocal Infant (70-100%) Informed consent obtained
Exclusion criteria
Exclusion criteria: infant over 24 months presence of other acute ilness like vomiting, sepsis diabetes mellitus metabolic disorders such a fatty acid disorders carnitine deficiency Pyruvate carboxylase deficiency ketotic hypoglycemia clinical suspicion of mitochondrial enzym deficiency less than 70% of intake of prescribed calorie requirements from Ketocal Infant milkintolerance Unable to adhere to protocol instructions investigators uncertainty about willingness of ability of the subject to comply with the protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intake and tolerance will be assassed by - comparising of the amount of Ketocal Infant consumed versus prescribed intake - documentation of tolerance to Ketocal Infant by the prescriber with due considerations given to intake and effect on GI symptoms (constipation, diarrhoea, vomiting ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Seizure and ketosis effect by - bloodketones to determine the effect of Ketocal Infant on ketosis - Seizure type and frequency recorded to determine effect on seizure reduction - Effect on symptoms ( level of sedation, muscle tone ) and reduction in medication will be recorded Growth will be measurede and recorded by - weight - length - head circumference | — |
Countries
Netherlands
Outcome results
None listed