Dietary Therapy in Children With Refractory Epilepsy

This study has been completed.
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: December 31, 2015
Last verified: December 2015
  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
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
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

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


Enrollment: 30
Study Start Date: April 2013
Study Completion Date: July 2014
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)
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

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   (Child, Adult)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01983163

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

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: December 31, 2015
Health Authority: India: Ministry of Health

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

ClinicalTrials.gov processed this record on August 22, 2016