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

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

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Other: Ketogenic diet (2.5 to 4:1); Other: Modified Atkin's diet

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110029
      • All India Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children aged 1-18 years with refractory epilepsy*
• Willing to come for regular follow up
• No motivational or psychosocial issues in the family which would preclude compliance with the diet

Exclusion Criteria

• Surgically remediable cause for refractory epilepsy
• Suspected mitochondrial disorder or diagnosed with a disorder in which high fat diet is contraindicated
• Previously received ketogenic diet or modified Atkins diet
• Chronic systemic disease like chronic kidney disease, chronic liver disease, heart disease (congenital and acquired) and chronic respiratory illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ketogenic diet; ketogenic diet (2.5 to 4:1)	Other: Ketogenic diet (2.5 to 4:1); Minimum ratio (2.5 to4:1) ketogenic diet causing ketosis will be given
Active Comparator: Modifid Atkin's diet; Modified Atkin's Diet	Other: Modified Atkin's diet; 1:1 fixed ketogenic ratio Modified atkins diet will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of seizure reduction at 6 months ( sz frequency / wk average of 4 wks) from base line	To develop an optimal dietary therapy for management of refractory epilepsy in children and adolescents	Baseline and 6 months

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Investigators: Principal Investigator: Sheffali Gulati, MD, AIIMS, New Delhi

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 4, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 13, 2013

Study Record Updates

• Last Update Posted (Estimate): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 31, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: 9968480606