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Completed

NCT Number: NCT01983163

Dietary Therapy in Children With Refractory Epilepsy

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

Completed

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketogenic diet (2.5 to 4:1)

Other

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

Modified Atkin's diet

Other

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

Primary outcomes

  1. Percentage of seizure reduction at 6 months ( sz frequency / wk average of 4 wks) from base line

    Time frame: Baseline and 6 months

    To develop an optimal dietary therapy for management of refractory epilepsy in children and adolescents

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 13, 2013
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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