NCT01899898

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

Phase 2/3 Study of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Lady Hardinge Medical College · Other Government
• Sex: All
• Age: 2 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

One third of children with epilepsy have seizures that are medically intractable. Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and cognitive impairment. Epilepsy surgery is not a feasible option for most children with refractory epilepsy. The ketogenic diet and the modified Atkins diet have been shown to be effective alternative treatments in children with refractory epilepsy. However, these need parents to be educated, and understand complex instructions of weighing foods and diet preparation. Therefore, children with parents with low levels of literacy and poor socioeconomic status have not been able to benefit from these therapies. Also, the paucity of trained dieticians and limited availability of labeled foods in resource-constraint settings has made these dietary therapies even more inaccessible. This study aimed to to develop a simple-to-administer variation of the modified Atkins diet for use in children with refractory epilepsy and to evaluate the efficacy and tolerability of this simplified modified Atkins diet in children with refractory epilepsy in a randomized controlled open-label trial.

Conditions

• Refractory Epilepsy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2013-07-16
• Last updated: 2019-01-15

Locations

1 site across 1 country: India