Effects of a Formula-Based Ketogenic Diet on Refractory Epilepsy in 1 to 3 Year-Old Patients under Classic Ketogenic Diet

OBJECTIVES: The classic ketogenic diet (CKD) as a potential epilepsy treatment with high-fat has not good tolerability in some patients, and so many families refuse to use this diet for long term especially in children younger than 2 year. In the present study, the efficacy and tolerability of the CKD only diet were compared with CKD combined a formula-based powder in children between 1 and 3 yr with intractable epilepsy. MATERIALS & METHODS: We randomly enrolled 45 children referred to Mofid Children’s Hospital, Tehran, Iran from April 2016 to May 2017 with refractory epilepsy for CKD only (control group), and formula based CKD (experimental group) treatment. Subjects were followed up for at least six months. RESULTS: Most of the patients in CKD only group did not tolerate the diet and were reluctant to eat homemade foods with high fat. All families of the patients younger than 2 yr old in this group chose to discontinue CKD and pursued other options. About 33% of the families of the patients younger than 2 yr old and 41.6% of the total patients between 1-3 yr old in experimental group stayed to the end of the trial, and all of them showed more than 90% reduction in seizure frequency after 6 months. Moreover, regardless of the other variables, using formula increased the chance of responding to treatment 7.32 times. CONCLUSION: A ketogenic diet using a powder ketogenic formula is effective, safe, and tolerable in infants and children with refractory seizure especially for younger patients who are reluctant to eat ketogenic homemade foods.