Clinical trial NCT03464487: Comparison Between Efficacy of Daily and Intermittent Low Glycemic Index Therapy Diet
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug Resistant Epilepsy
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of seizure reduction from baseline at 24 weeks in each arm
timeFrame: Percentage seizure reduction will be calculated for each child in each arm after 24 weeks follow up period is completed and finally mean seizure reduction in each arm will be computed at the end of 24 weeks
Secondary outcomes:
measure: Proportion of patients with >50% seizure reduction in each dietary arm
timeFrame: At the end of 24 weeks, it will be determined the proportion of children in each arm with >50% reduction in seizure frequency.
measure: Change in social quotient with each dietary therapy
timeFrame: Vineland Social Maturity Scale will be done for each child at baseline and at 24 weeks to calculate social quotient at baseline and 24 weeks
measure: Proportion of patients with different clinical adverse events in each group
timeFrame: Each child will be monitored for adverse effects clinically at 12 weeks and 24 weeks
measure: Correlate seizure frequency change at 24 weeks with blood HbA1c levels
timeFrame: Absolute level of HbA1c levels (in percentage) as compared to percentage change in seizure frequency at 3 and 6 months will be computed
measure: Correlate seizure frequency change at 24 weeks with blood betahydroxy butyrate levels levels
timeFrame: Blood beta hydroxyl butyrate levels(milimoles/liter) at 12 and 24 weeks as compared to percentage change in seizure frequency will be computed
measure: Proportion of patients with different biochemical adverse events in each group
timeFrame: Each child will be monitored by certain biochemical investigations like hemoglobin, liver and renal function tests and lipid profile at baseline, at 24 weeks and also in between if clinically indicated
Other outcomes:
Locations:
city: New Delhi
country: India
facility: AIIMS
state: Delhi
Study officials:
affiliation: AIIMS, New Delhi
name: Sheffali Gulati, M.D.
role: PRINCIPAL_INVESTIGATOR
References: