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van CCT (UK)

van CCT (UK)

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

- candidate number8425
- NTR NumberNTR2498
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-sep-2010
- Secondary IDs10-018/K METC
- Public TitleCost-effectiveness of a ketogenic diet in children with therapy-resistant epilepsy.
- Scientific TitleCost-effectiveness of a ketogenic diet in children with intractable epilepsy: A Dutch randomized controlled trial.
- hypothesisWe hypothesize that the Ketogenic diet will be cost-effective compared to usual care.
- Healt Condition(s) or Problem(s) studiedCost-effectiveness , Epilepsy, Therapy resistent , Seizures, Ketogenic diet, Economic evaluation
- Inclusion criteriaChildren and adolescents between 1-18 years old with intractable epilepsy.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2010
- planned closingdate1-jan-2015
- Target number of participants50
- InterventionsKetogenic 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 use at the time of inclusion in the study will be continued without changes (except when medically indicated). The initial calorie prescription for the Ketogenic diet is based on an average between the pre-diet intake and the recommendations for energy requirements, taking into account current and previous weight and height, recommended calorific requirements and levels of physical activity.

Waiting list control group:
In the event of the patient being randomized into the waiting list, he or she receive their usual care, which means that they will continue to take their anti-epileptic drugs and no changes will be made to the anti-epileptic drugs treatment. Since a Ketogenic diet is a last resort treatment, the children in the control group will also receive a Ketogenic diet after a 4-month delay. The controls will be treated and monitored according to the same protocol as described in this proposal; however, this is not part of our proposed study.
- Primary outcome1. 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 outcome1. 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.
- TimepointsBaseline (4 week period), visit 6 weeks and 4 months (after end baseline), 3, 6, 9, 12 months follow-up (after end intervention period).
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Epilepsy Centre Kempenhaeghe
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryEpilepsy is a cost-intensive neurological disorder, characterized by recurrent unprovoked seizures. In addition to the economic burden, epilepsy imposes a substantial burden on the patients themselves and their surroundings. Patients with uncontrolled epilepsy heavily depend on informal care and health care professionals. Although, epilepsy is treatable with anti-epileptic drugs in the majority of cases, about 30% of patients suffer from drug-resistant epilepsy. The Ketogenic diet is a last resort treatment for these children. Currently, the Ketogenic diet as a treatment option for children is often overlooked and underutilized. However, the beneficial effect of Ketogenic diet has been proven in multiple observational studies, reviews, and one randomized controlled trial but there is still lack of information about the cost-effectiveness. In the current study we will evaluate the (cost-) effectiveness of the Ketogenic Diet, compared to a waiting list, in children and adolescents with refractory epilepsy between 1 and 18 years of age.
Name study: KOEK (NL:KOsten-Effectiviteit van het Ketogeen dieet).
- Main changes (audit trail)
- RECORD10-sep-2010 - 26-sep-2010

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