NCT01880333

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Lady Hardinge Medical College · Other Government
• Sex: All
• Age: 9 Months – 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Refractory Epilepsy

Interventions

Type	Name	Description
OTHER	Modified Atkin Diet	Eligible children will be started on Modified Atkins diet with help of trained dietician. Carbohydrates intake will be restricted to 5 grams/ day in children\<18 mo and 10grams/day in children 18mo- 3 years.Carbohydrate values of various food items will be explained in detail. Fats (e.g. cream, butter, oils, and ghee) will be encouraged. Proteins (cheese, fish, eggs, chicken, and soya products) will be unrestricted. Calcium and multivitamin supplementation will be done. Syrups will be restricted. Clear carbohydrates free fluids- will not be restricted. Medications will be changed to carbohydrate free preparations, wherever available. Diary of events will be recorded including seizure frequency and any adverse or positive effect. Urine ketones chart will be maintained.

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-06-18
• Last updated: 2019-01-15

Locations

1 site across 1 country: India