A Prospective, Case-control Evaluation of Ketogenic Dietary Therapy for New-onset Childhood Absence Epilepsy

What this Trial Is About

Researchers are evaluating the use of the ketogenic diet, specifically a modified Atkins diet, as a treatment option for children aged 3 to 12 years with new-onset childhood absence epilepsy. This small, prospective, non-randomized trial compares dietary therapy to standard anticonvulsant medications, aiming to assess whether the diet is a feasible and effective first-line treatment. The study addresses a gap in current knowledge about dietary approaches for new epilepsy cases, building on prior evidence supporting diet use in refractory epilepsy and certain rare conditions. Participants will either follow a modified Atkins diet, which is a low carbohydrate, high fat, and moderate protein diet started as an outpatient approach, or receive usual care with anticonvulsant medications like ethosuximide, valproate, or lamotrigine. The diet group will monitor urine ketones twice weekly and receive dietitian support, with lab tests at baseline and 3 months. The medication group will have dose adjustments and drug level monitoring as usual. The study includes baseline, 1 month, and 3-month visits with EEG and lab assessments. During the study, children will have clinic visits at the start, after 1 month, and after 3 months to evaluate seizure frequency and EEG changes. Researchers will measure the primary outcome of seizure frequency changes and secondary outcomes including diet tolerability, duration, urinary ketone changes, and EEG normalization. Families will follow up with their neurologists and insurance will cover routine labs and clinic visits. This trial aims to understand if dietary therapy can be an alternative to medication for new-onset childhood absence epilepsy.

Ketogenic Diet for New-Onset Absence Epilepsy