Aim: This study evaluated the efficacy and tolerability of the ketogenic diet (KD) in young Indian children with refractory epilepsy. The changes in biochemical and lipid profile with KD were also assessed.
Methods: Children aged 6 months to 5 years who had daily seizures (or at least 7 seizures/week) despite the appropriate use of at least three antiepileptic drugs were enrolled. KD was introduced using a non-fasting gradual initiation protocol. Seizure frequency, biochemical profile (liver and kidney function tests, fasting lipid profile, and spot urinary calcium-creatinine ratio) and adverse effects were recorded. Patients continuing KD were followed up for a minimum period of 12 months.
Results: Twenty-seven children were enrolled. Non-fasting gradual KD initiation was well tolerated. Eighty-eight percent remained on KD at 3 months, 55% remained on KD at 6 months, and 37% remained on it at 1 year. Intention-to-treat analysis revealed that 48% (13 of 27) had >50% reduction in seizures, and four children (15 %) were seizure free at 6 months. At 1 year, 37% had >50% reduction in seizures and five children (18.5%) were seizure free. Adverse effects included constipation (74%), weight loss (14.8%), edema due to hypo-albuminemia (7.4%) and renal stones (3.7%). Biochemical profile did not reveal significant changes over time, except for reduced serum albumin and increased spot urinary calcium-creatinine ratio.
Conclusion: KD is an effective and well-tolerated treatment option in young Indian children with refractory epilepsy. However, careful ongoing medical supervision is needed.