Ketogenic Dieting Clinical Trial
Official title:
A Prospective, Case-control Evaluation of Ketogenic Dietary Therapy for New-onset Childhood Absence Epilepsy
The ketogenic diet is a medical therapy for epilepsy that is used nearly predominantly for refractory epilepsy (after 2-3 drugs have been tried and failed). However, there is both published evidence for first-line use (infantile spasms, Glut1 deficiency syndrome) and also anecdotal experience (families choosing to change the child's (or the family' own) diet rather than use anticonvulsant medications). Childhood absence epilepsy (refractory) has been published as being responsive to ketogenic diet therapy by the investigators' group previously. This is a small, prospective, 3 month trial to assess if using a modified Atkins diet is a feasible and effective option for new-onset childhood absence epilepsy. The investigators will compare to a group of children in which the parents have declined and chose to start anticonvulsant medications.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | May 1, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 12 Years |
Eligibility | Inclusion Criteria: - Children ages 3-12 years at seizure onset with classic childhood absence epilepsy clinically. - Normal intellect or mild disability - EEG with confirmed 3/second spike-wave discharges, usually with hyperventilation - Daily reported absence seizures. - Generalized convulsions allowed Exclusion Criteria: - Previous treatment with any anticonvulsant drug - Previous use of a ketogenic dietary therapy for epilepsy or any other condition - Glut1 deficiency syndrome - Metabolic disorder known that would preclude dietary therapy - Dietary restrictions for which a high fat, low carbohydrate diet would be precluded. - Prior history of epilepsy (febrile seizures allowed) - Unwilling to consent to study procedures or return for visits |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Groomes LB, Pyzik PL, Turner Z, Dorward JL, Goode VH, Kossoff EH. Do patients with absence epilepsy respond to ketogenic diets? J Child Neurol. 2011 Feb;26(2):160-5. doi: 10.1177/0883073810376443. Epub 2010 Jul 20. — View Citation
Kossoff EH, Hedderick EF, Turner Z, Freeman JM. A case-control evaluation of the ketogenic diet versus ACTH for new-onset infantile spasms. Epilepsia. 2008 Sep;49(9):1504-9. doi: 10.1111/j.1528-1167.2008.01606.x. Epub 2008 Apr 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in seizure frequency | Parental report of seizure frequency. | At 1 and 3 months post treatment | |
Secondary | Tolerability of diet therapy as assessed by restrictiveness of the diet therapy | Diet therapy restrictiveness will be assessed with an open ended questionnaire that asks "how hard has it been for the child?". Completely subjective with no scale or scoring. | At 3 months | |
Secondary | Tolerability of diet therapy as assessed by restrictiveness of the diet therapy | Diet therapy restrictiveness will be assessed with an open ended questionnaire that asks "how hard has it been for the child?". Completely subjective with no scale or scoring. | At 6 months | |
Secondary | Duration of diet therapy | Duration of diet therapy in months. | Up to 3 months post treatment | |
Secondary | Tolerability of diet therapy as assessed by change in urinary ketones | Urinary ketones in mg/dl will be measured (80-160mg/dl is considered large ketosis). | At 1 and 3 months post treatment | |
Secondary | EEG changes (normalization of the baseline spike-wave bursts) | 30 minute routine EEG including hyperventilation to induce seizures, compare 3 months to baseline | Baseline and at 3 months post treatment |
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