Clinical Trial: Evaluation of the Modified Atkins Diet in Young Children With Refractory Epilepsy

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase 2/3 Study of the Modified Atkins Diet in Young Children With Refractory Epilepsy

Brief Summary: The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. This diet is started on an outpatient basis without a fast, allows unlimited protein and fat, and does not restrict calories or fluids. Modified Atkins diet is of special importance in resource constraint settings with paucity of trained dieticians. However, there is paucity published data on the use of the modified Atkins diet in refractory epilepsy in young children. This study aims to evaluate the efficacy and tolerability of the modified Atkins diet in refractory epilepsy in young children.

Detailed Summary:
Sponsor: Lady Hardinge Medical College

Current Primary Outcome: Proportion of children with > 50% seizure reduction at 3 months [ Time Frame: After 3 months of diet initiation ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Frequency of adverse effects of the modified Atkins diet. [ Time Frame: 3 months ]

Original Secondary Outcome: Same as current

Information By: Lady Hardinge Medical College

Dates:
Date Received: June 13, 2013
Date Started: March 2013
Date Completion: March 2014
Last Updated: July 9, 2013
Last Verified: June 2013