Refractory Epilepsy Clinical Trial
Official title:
Efficacy of Low Glycemic Index Diet Therapy in Children With Refractory Epilepsy - A Randomized Controlled Trial
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.
Status | Unknown status |
Enrollment | 40 |
Est. completion date | October 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 15 Years |
Eligibility |
Inclusion Criteria: 1. Children aged 2 -15 years with refractory epilepsy* 2. Willing to come for regular follow up 3. No motivational or psychosocial issues in the family which would preclude compliance with the diet * Refractory epilepsy is defined as seizures persisting daily or more than 7 per week despite the adequate trials of at least three tolerated and appropriately chosen anti-epileptic drugs including one newer antiepileptic drug (either alone or in combination). In case of infantile spasms, epileptic spasms with the onset before 2 years of age, with or without electroencephalographic evidence of hypsarrhythmia or its variants, persisting for more than 3 weeks, at least 7 cluster per week, despite treatment with at least 2 appropriate AEDs, and any one of the following; corticosteroids or vigabatrin will be considered as eligible for inclusion. Exclusion Criteria: 1. Surgically remediable cause for refractory epilepsy 2. Suspected mitochondrial disorder or diagnosed with a disorder in which high fat diet is contraindicated 3. Previously received ketogenic diet or modified Atkins diet 4. Chronic systemic disease like chronic kidney disease, chronic liver disease, heart disease (congenital and acquired) and chronic respiratory illness |
Country | Name | City | State |
---|---|---|---|
India | All India Institute of Medical Sciences | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Adverse events | Proportion and nature of adverse events in both the groups | 3 months | |
Secondary | Withdrawal rate | Proportion of patients withdrawing from the LGIT plus antiepileptic drug treatment group during the study period and reasons for withdrawal. | 3 months. |
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