Introduction: There are scant data regarding the efficacy and tolerability of the modified Atkins diet (MAD) in young children with refractory epilepsy. This study was conducted to address these issues.

Methods: This prospective interventional study was carried out between March 2013 and November 2013 at a tertiary care centre in North India. Children aged 9 months to 3 years who had at least 3 seizures per week for > 1-month despite the appropriate use of at least two anticonvulsant drugs were enrolled. The eligible children were initiated on the MAD. The ongoing anticonvulsant medications were continued unchanged. The seizure control at 3 and 6-months were the end points. Analysis was intention to treat. Adverse effects of the diet were assessed by the parental reports (ClinicalTrials.gov Identifier: NCT01880333).

Results: Twenty-two children were enrolled during the study period. The median age at first seizures and diet initiation were 4 months (1 day-17 months) and 18.5 months (10-27 months), respectively. At 3-months, 13 children were on diet. One (4.5%) was seizure free, 10 (45.5%) had > 50% reduction of seizures as compared to baseline, 2 (9%) had <50% seizure reduction. At 6-months, 7 children were on diet. Two (9%) was seizure free, 4 (18%) had > 50% reduction of seizures as compared to baseline, 1 (4.5%) had <50% seizure reduction. Constipation was the most common adverse effect among children on the diet (6, 22%).

Conclusions: The MAD was found to be effective and well tolerated in children with refractory epilepsy.