pharmacoresistant epilepsy
Conditions
Interventions
Ketogenic Diet Therapy (KDT) is a specialist medical diet for children with
pharmaco resistant (i.e.2-3 anti-epileptic drugs have failed) epilepsy. It is
an extremely high fat (71-90 en%), very low
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: -age 2-12 years -seizures inadequately responding to 2-3 anti-epileptic drugs -or experiencing severe side effects on anti-epileptic drugs -or on waiting list for epilepsy surgery -be able to read Dutch language -signed informed consent
Exclusion criteria
Exclusion criteria: -complex medical condition requiring hospitalization for ketogenic diet initiation -age 12 years -KDT used in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary parameter/endpoint Percentage of included patients having ketone levels > 3 mmol/l within4 months after start Ketogenic Diet Therapy by using the KetoEasy mealplan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints - Ketone levels (daily measured) during 4 month study period (median/mean and range mmol/l in blood week 1-5, month 2,3,4 and total study period) - Time to adequate ketosis (in days) after diet initiation - Number and kind of side effects: hyperketosis (>6.5 mmol/l), hypoglycemia (5 mmol/l , triglycerides >3 mmol/l), gastro-intestinal problems (constipation, vomiting, diarrhea), food refusal, weight loss (>5% of baseline weight) -Seizure reduction defined as > 50% seizure reduction 3 months after completing KDT dietinitiation -Number of drop outs and reason for stopping -Feasibility of KDT application by the use of the KetoEasy meal plan user-friendliness, variety and application in daily use by parents. -Nutritional composition of the food intake at baseline, at week 5 and end study (energy, protein, fat and carb) Other study parameters -Feasibility of KDT as use of KetoEasy meal plan during initiation, fine tuning and follow up by the dietitians and medical doctors of the ketoteam. | — |
Countries
Netherlands
Outcome results
None listed