EN:Epilepsy, Seizures, Intractable, Ketogenic diet, Cost-effectiveness, Economic evaluation NL:Epilepsie, Aanvallen, Therapie resistent, ketogeen dieet, Kosten-effectiviteit, Economische evaluatie
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Children and adolescents between 1-18 years old with intractable epilepsy.
Exclusion criteria
Exclusion criteria: 1. Fatty acid oxidation disorders and related diseases; 2. Diabetes and hyperinsulinism; 3. Prolonged QT-time syndrome; 4. Hypercholesterolemia, hypertriglyceridemia; 5. Severe liver, kidney or pancreas diseases; 6. Renal tubular acidosis; 7. Treatment with topiramate or acetazolamide and a positive family history or other risk factors for kidney stones or acidosis; 8. Severe behavioural disorder; 9. Malnutrition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. A 50% reduction of the proportion of seizures, timepoint: 16 months; 2. Cost per seizure reduction, timepoint: 16 months; 3. Cost per QALY, timepoint: 16 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Seizure frequency and severity, timepoint:16 months; 2. Side effects, timepoint:16 months; 3. Psychological assessment, timepoint: 16 months; 4. Quality of life, timepoint: 16 months; 5. Costs and productivity losses, timepoint: 16 months; 6. Credibility and expectancy, timepoint: 16 months. | — |
Contacts
Postbus 61