Efficacy of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Refractory Epilepsy
Interventions
OTHER

Simplified Modified Atkins Diet

"Modified Atkins diet with the following modifications:~1. Pictorial representation of various food items and exchange lists will be provided.~2. Instead of weights, we will provide standardized measures~3. We will calculate the amount of carbohydrates of daily readily available foods in the standardized measures~4. We will formulate recipes and diets based on locally available and culturally acceptable foods.~5. We will develop a parent instruction manual.~6. We will also develop methods for parents with low levels of literacy to maintain seizure logs. This will be done by using bars and color codes.~7. We will develop methods for parents with low levels of literacy to measure and record urine ketones. This will be done by using color codes."

DRUG

Antiepileptic drugs alone

The anti-epileptic drugs will be continued alone for 3 months following which they will be offered Simplified Modified Atkins Diet

Trial Locations (1)

110001

Division of Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi

All Listed Sponsors
lead

Lady Hardinge Medical College

OTHER_GOV

NCT01899898 - Efficacy of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy | Biotech Hunter | Biotech Hunter