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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by All India Institute of Medical Sciences, New Delhi
Sponsor:
Information provided by (Responsible Party):
Sheffali Gulati, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01983163
First received: November 4, 2013
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Ketogenic Diet, Modified Atkin's Diet, Refractory Epilepsy
Other: Ketogenic diet (2.5 to 4:1)
Other: Modified Atkin's diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Percentage of seizure reduction at 6 months ( sz frequency / wk average of 4 wks) from base line [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    To develop an optimal dietary therapy for management of refractory epilepsy in children and adolescents


Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ketogenic diet
ketogenic diet (2.5 to 4:1)
Other: Ketogenic diet (2.5 to 4:1)
Active Comparator: Modifid Atkin's diet
Modified Atkin's Diet
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

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983163

Contacts
Contact: Sheffali Gulati, MD Pediatrics 01126594679 sheffaligulati@gmail.com

Locations
India
All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: Sheffali Gulati, MD, Pediatrics    01126594679    sheffaligulati@gmail.com   
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Sheffali Gulati, Addl. Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01983163     History of Changes
Other Study ID Numbers: 9968480606
Study First Received: November 4, 2013
Last Updated: November 7, 2013
Health Authority: India: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014