Dietary Therapy in Children With Refractory Epilepsy

All India Institute Of Medical Science (AIIMS)

Status and phase

Completed

Phase 2

Conditions

Epilepsy

Treatments

Other: Modified Atkin's diet

Other: Ketogenic diet (2.5 to 4:1)

Study type

Interventional

Funder types

Other

Identifiers

NCT01983163

9968480606

Details and patient eligibility

About

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

Full 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

Enrollment

30 patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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