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Low Glycemic Index Diet Therapy in Children With Refractory Epilepsy

NCT01645072 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-07-20

No results posted yet for this study

Summary

Epilepsy is a frequent cause of morbidity in the pediatric age group. Many catastrophic epilepsies present during infancy and childhood1. Seizures in these epileptic disorders are difficult to control; sometimes only at the expense of multiple and toxic levels of antiepileptic medications. The shortcomings of antiepileptic drug therapy and epilepsy surgery warrants the need for alternative treatments. Ketogenic diet is effective for refractory epilepsies (33% of patients with refractory epilepsy have more than 50% reduction in seizures from the baseline and 15-20% become seizure free) and has gained widespread acceptance. Low glycemic index diet treatment (LGIT) is designed as a variant of ketogenic diet. There are retrospective studies on LGIT in childhood refractory epilepsy reporting seizure reduction comparable to that of patients on ketogenic diet. There have been no randomized controlled trials assessing the efficacy of the low glycemic index diet in refractory epilepsy. In this study we plan to assess the efficacy of LGIT among children with drug refractory epilepsy.

Conditions

  • Refractory Epilepsy

Interventions

OTHER

Low glycemic index diet

Diet modification in addition to ongoing anti epileptic drug treatment. Medium and high-GI carbohydrates (GI \>55) will be eliminated from the diet and only food items with low glycemic index (GI \<55) will be allowed. Parent will be given a list of low glycemic index food items. They will also be given a list of food items (medium and high glycemic index) which should be avoided.

OTHER

Control group

The ongoing anti epileptic drug treatment will be continued without change.

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Sheffali Gulati, MD · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-08-31
Completion
2012-10-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01645072 on ClinicalTrials.gov