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

All India Institute Of Medical Science (AIIMS)

Status: Unknown

Conditions: Drug Resistant Epilepsy

Treatments: Dietary Supplement: Low Glycemic Index Therapy Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03464487

Daily vs Intermittent LGIT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 1 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children aged 1-15 years with drug resistant epilepsy
2. Willing to come for regular follow up

Exclusion criteria

1. Surgically remediable cause for drug resistant epilepsy

2. Proven in born error of metabolism except in which dietary therapy for epilepsy is indicated(i.e. pyruvate carboxylase deficiency and GLUT 1 deficiency)

3. Previously received KD, MAD or LGIT

4. Known case of

   • Chronic kidney disease
   • Chronic liver disease/GI illness
   • Chronic heart disease(congenital and acquired)
   • Chronic respiratory illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Daily LGIT

Active Comparator group

Description:

The children with drug resistant epilepsy in this arm will receive Low Glycemic Index Therapy diet everyday along with the antiepileptic drugs.

Treatment:

Dietary Supplement: Low Glycemic Index Therapy Diet

Intermittent LGIT

Active Comparator group

Description:

The children with drug resistant epilepsy in this arm will receive Low Glycemic Index Therapy Diet on five days of each week along with antiepileptic drugs. Rest of the two days, they will receive a liberal diet.

Treatment:

Dietary Supplement: Low Glycemic Index Therapy Diet