Dietary Therapy in Children With Refractory Epilepsy

Phase 2

Completed

• Conditions: Epilepsy
• Interventions: Other: Modified Atkin's diet

• Registration Number: NCT01983163
• Lead Sponsor: 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

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-13
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-31
• Last Update Posted: 2016-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modifid Atkin's diet	Modified Atkin's diet	Modified Atkin's Diet

Primary Outcome Measures

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

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India