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Cost-effectiveness of a ketogenic diet in children with therapy-resistant epilepsy.

Cost-effectiveness of a ketogenic diet in children with intractable epilepsy: A Dutch randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON19966
Enrollment
50
Registered
2010-09-10
Start date
2010-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EN:Epilepsy, Seizures, Intractable, Ketogenic diet, Cost-effectiveness, Economic evaluation NL:Epilepsie, Aanvallen, Therapie resistent, ketogeen dieet, Kosten-effectiviteit, Economische evaluatie

Interventions

however, this is not part of our proposed study.
Ketogenic diet: The Ketogenic diet is calculated on an individual basis by the dietician and is introduced during a hospitalization of 1 week. The anti-epileptic drugs the children and adolescents us

Sponsors

Epilepsiecentrum Kempenhaeghe
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactH.J.M. Majoie

Postbus 61

majoiem@kempenhaeghe.nl+31 (0)40 2279263

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)