Clinical Trial: Low Glycemic Index Diet Therapy in Children With Refractory Epilepsy
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Efficacy of Low Glycemic Index Diet Therapy in Children With Refractory Epilepsy - A Randomized Controlled Trial
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.
Detailed Summary:
Each patient will undergo detailed clinical evaluation according to a structured proforma. Seizure type, frequency, age at onset, perinatal details, family history, developmental status and treatment history will be recorded. Corticosteroids or ACTH (if patient is already on) would be tapered off 2 weeks before starting LGIT. All co-medications will be changed to carbohydrate free preparations, wherever available only in the intervention group.
Eligible patients will be randomized in to two groups: the intervention and the control arm. Both groups will undergo a baseline four week observation period, during which parents will be asked to maintain a daily seizure log; recording seizure type, duration and frequency. In the intervention arm, the children will be started on low glycemic index diet after this 4-week baseline period. 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. The drop out from the intervention group will be documented along with the reason for the same. At the end of the 3 month study period patient in the intervention arm will be continued with the LGIT but that will not come under the purview of this study. At the end of three months study period, patients in the control arm will be offered the option of low glycemic index diet treatment.
Low glycemic index diet administration
- Three day food intake by recall method will be documented
Sponsor: All India Institute of Medical Sciences, New Delhi
Current Primary Outcome: Seizure control [ Time Frame: 3 months ]
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
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adverse events [ Time Frame: 3 months ]Proportion and nature of adverse events in both the groups
- Withdrawal rate [ Time Frame: 3 months. ]Proportion of patients withdrawing from the LGIT plus antiepileptic drug treatment group during the study period and reasons for withdrawal.
Original Secondary Outcome: Same as current
Information By: All India Institute of Medical Sciences, New Delhi
Dates:
Date Received: July 16, 2012
Date Started: June 2011
Date Completion: October 2012
Last Updated: July 17, 2012
Last Verified: July 2012
- Adverse events [ Time Frame: 3 months ]
