Dietary Therapy in Children With Refractory Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01983163
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : January 1, 2016
Information provided by (Responsible Party):
Sheffali Gulati, All India Institute of Medical Sciences, New Delhi

Brief 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

Condition or disease Intervention/treatment Phase
Epilepsy Other: Ketogenic diet (2.5 to 4:1) Other: Modified Atkin's diet Phase 2

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Modified Atkins Diet Versus Ketogenic Diet in Children With Refractory Epilepsy Aged 1 Year to 18 Years: a Randomized Controlled Trial
Study Start Date : April 2013
Primary Completion Date : June 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01983163

All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Principal Investigator: Sheffali Gulati, MD AIIMS, New Delhi

Responsible Party: Sheffali Gulati, Addl. Professor, All India Institute of Medical Sciences, New Delhi Identifier: NCT01983163     History of Changes
Other Study ID Numbers: 9968480606
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases