Dietary Therapy in Children With Refractory Epilepsy

NCT01983163 | Completed Phase 2 DMC

• 1 other identifier: 9968480606
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ketogenic diet

ACTIVE COMPARATOR

ketogenic diet (2.5 to 4:1)

Other: Ketogenic diet (2.5 to 4:1)

Modifid Atkin's diet

ACTIVE COMPARATOR

Modified Atkin's Diet

Other: Modified Atkin's diet

Interventions

Ketogenic diet (2.5 to 4:1) OTHER

Minimum ratio (2.5 to4:1) ketogenic diet causing ketosis will be given

ketogenic diet

Modified Atkin's diet OTHER

1:1 fixed ketogenic ratio Modified atkins diet will be given

Modifid Atkin's diet

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sheffali Gulati, MD

  AIIMS, New Delhi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Addl. Professor

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 13, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 1, 2016

Record last verified: 2015-12

Locations

IN (1)