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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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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

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Drug Resistant Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daily LGIT

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

Group Type ACTIVE_COMPARATOR

Low Glycemic Index Therapy Diet

Intervention Type DIETARY_SUPPLEMENT

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.

Intermittent LGIT

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.

Group Type ACTIVE_COMPARATOR

Low Glycemic Index Therapy Diet

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No