Dietary Therapy in Children With Refractory Epilepsy

Phase 2CompletedNCT01983163

All India Institute of Medical Sciences30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy

Interventions

Ketogenic diet (2.5 to 4:1)OTHER

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

Modified Atkin's dietOTHER

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

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

Time frame: Baseline and 6 months

Data from ClinicalTrials.gov

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