NCT03464487

Comparison Between Efficacy of Daily and Intermittent Low Glycemic Index Therapy Diet

Comparison Between Efficacy of Daily and Intermittent Low Glycemic Index Therapy Diet Among Children With Drug Resistant Epilepsy Aged 1-15 Years: an Open Labeled Randomized Controlled Parallel Design Non-inferiority Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: All India Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 1 Year – 15 Years
• Healthy volunteers: Not accepted

Summary

Drug resistant epilepsy constitutes about one third of all children diagnosed with epilepsy. Although ketogenic diet is being used for drug resistant epilepsy for almost hundred years, its restrictiveness and adverse effects interferes with its compliance. So less restrictive alternatives like Low Glycemic Index Therapy diet is gradually becoming more popular and its effectiveness is well established. Still the restrictiveness of such monotonous diets is one of the most significant issues for long term maintenance of children on dietary therapy. In this study, we are planning to compare the efficacy of daily and intermittent Low Glycemic Index therapy Diet in children aged 1-15 years with drug resistant epilepsy in a open labelled randomized controlled non-inferiority trial. The children in intermittent LGIT arm will receive the dietary therapy for five days of each week, alternating with a liberal diet on the rest of the two days of the week.

Detailed description

Drug resistant epilepsy constitutes about one third of all children diagnosed with epilepsy. Although ketogenic diet is being used for drug resistant epilepsy for almost hundred years, its restrictiveness and adverse effects interferes with its compliance. So less restrictive alternatives like Low Glycemic Index Therapy diet is gradually becoming more popular and its effectiveness is well established. Still the restrictiveness of such monotonous diets is one of the most significant issues for long term maintenance of children on dietary therapy. In this study, we are planning to compare the efficacy of daily and intermittent Low Glycemic Index therapy Diet in children aged 1-15 years with drug resistant epilepsy in a open labelled randomized controlled non-inferiority trial. The children in intermittent LGIT arm will receive the dietary therapy for five days of each week, alternating with a liberal diet on the rest of the two days of the week. With a follow up period of 6 months, we are planning to enroll 55 children in each arm. Adverse effect profile in each arm will also be monitored during the study. Also the effect of the dietary therapy on behavior and cognition in each arm will be assessed.

Conditions

• Drug Resistant Epilepsy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low Glycemic Index Therapy Diet	Low Glycemic Index Therapy Diet allows only carbohydrates with Glycemic Index less than 50 and also restricts daily carbohydrate intake to less than 40-60 gram per day.

Timeline

• Start date: 2018-02-15
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2018-03-14
• Last updated: 2018-03-14

Locations

1 site across 1 country: India