Low Glycemic Index Diet Therapy in Children With Refractory Epilepsy

NCT01645072 | Unknown Phase 3

• 1 other identifier: AIIMS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Drug refractory epilepsy; Dietary therapy; ketogenic diet; childhood epilepsy

Outcome Measures

Primary Outcomes (1)

• Seizure control

  Proportion of patients who achieve \> 50% seizure reduction (Seizure frequency measured as average seizure per week in the preceding 4 week period) from the baseline

  3 months

Secondary Outcomes (2)

• Adverse events

  3 months

• Withdrawal rate

  3 months.

Study Arms (2)

Low glycemic index diet

EXPERIMENTAL

The patients will be started on low glycemic index diet.

Other: Low glycemic index diet

Control group

OTHER

Standard care. The control group will receive their usual diet without any alteration. No changes will be made to the patients' antiepileptic medication during the 4-week baseline or the 3-month study periods in both the intervention and control groups, unless medically indicated; e.g. drug side effects, or status epilepticus; in which case appropriate changes will be made to their medications and same will be documented.

Other: Control group

Interventions

Low glycemic index diet OTHER

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.

Low glycemic index diet

Control group OTHER

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

Control group

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 2 -15 years with refractory epilepsy\*
• Willing to come for regular follow up

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

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

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sheffali Gulati, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheffali Gulati, MD

CONTACT

+91-11-26594679; sheffaligulati@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 20, 2012
• Study Start: June 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

IN (1)