Dietary Therapy in Children With Refractory Epilepsy

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983163
• Other study ID #: 9968480606
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2013
• Last updated: December 31, 2015
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2015
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Ketogenic diet (2.5 to 4:1)
Minimum ratio (2.5 to4:1) ketogenic diet causing ketosis will be given
• Modified Atkin's diet
1:1 fixed ketogenic ratio Modified atkins diet will be given

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No