NCT01983163

Dietary Therapy in Children With Refractory Epilepsy

Efficacy of Modified Atkins Diet Versus Ketogenic Diet in Children With Refractory Epilepsy Aged 1 Year to 18 Years: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: All India Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to ongoing AED therapy would not be inferior compared to ketogenic diet \*\* in terms of seizure reduction from baseline seizure frequency at 6 months

Detailed description

Primary objective: To compare the efficacy of Modified Atkins diet compared to Ketogenic diet \* in children aged 1 year to 18 years of age with refractory epilepsy on anti epileptic drugs at 6 months of diet intake in terms of percentage of seizure reduction from base line. Secondary objective: Proportion of patients who achieve \> 50% seizure reduction from baseline after 6 months in both groups To evaluate the nature of adverse events in both the groups

Conditions

• Epilepsy

Interventions

Type	Name	Description
OTHER	Ketogenic diet (2.5 to 4:1)	Minimum ratio (2.5 to4:1) ketogenic diet causing ketosis will be given
OTHER	Modified Atkin's diet	1:1 fixed ketogenic ratio Modified atkins diet will be given

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2013-11-13
• Last updated: 2016-01-01

Locations

1 site across 1 country: India