Dietary Therapy in Children With Refractory Epilepsy

Efficacy of Modified Atkins Diet Versus Ketogenic Diet in Children With Refractory Epilepsy Aged 1 Year to 18 Years: a Randomized Controlled Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01983163

Enrollment

Registered

2013-11-13

Start date

2013-04-30

Completion date

2014-07-31

Last updated

2016-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

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

Interventions

OTHERKetogenic diet (2.5 to 4:1)

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

OTHERModified Atkin's diet

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026