Dietary Therapy in Children With Refractory Epilepsy

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

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

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: ketogenic diet
    • ketogenic diet (2.5 to 4:1)
  • Active Comparator: Modifid Atkin’s diet
    • Modified Atkin’s Diet

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • All India Institute of Medical Sciences, New Delhi
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sheffali Gulati, Addl. Professor – All India Institute of Medical Sciences, New Delhi
  • Overall Official(s)
    • Sheffali Gulati, MD, Principal Investigator, AIIMS, New Delhi

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