A randomized controlled trial of two ketogenic diets in the treatment of childhood epilepsy

This thesis describes the first randomized controlled trial on the ketogenic diet as a treatment for children with drug-resistant epilepsy. It asks two main questions. Firstly, are there clear benefits on seizure control in children treated with the ketogenic diet as compared with no additional treatment and secondly, is the classical ketogenic diet more efficacious than the medium chain triglyceride (MCT) ketogenic diet, as often claimed but not supported by scientific evidence The trial also examines the tolerability of the two diets, and their effect on growth. 145 children were randomized to receive the classical or MCT diet, either immediately or after a 3-month delay with no change in treatment (control group). Seizure frequency was assessed after 3 months, compared to that of controls. Efficacy and tolerability of the two diets was compared at 3, 6 and 12 months. Growth was assessed during the study period. Clear guidelines on calculation of both diets were developed, as was an electronic ketogenic calculator to reduce the burden of time spent on recipe calculations. Results show children on a ketogenic diet to have significantly reduced numbers of seizures after 3 months, as compared to the control group. Despite increased ketone levels in classical diet children, there was no difference in efficacy between the two diets at 3, 6 or 12 months. There was no difference in gastro-intestinal tolerability both diets caused increased cholesterol levels, but increased triglyceride levels were seen in the classical group only. Many children did show compromised growth during the study, but after 12 months, there was no significant difference in growth outcome between the two diets. These results strongly support using the ketogenic diet in childhood epilepsy. Classical and MCT diets are comparable in efficacy, tolerability and growth outcomes both protocols continue to have their place in the treatment of this group of children.