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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
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.
AIIMS
New Delhi, National Capital Territory of Delhi, India
RECRUITINGPercentage of seizure reduction from baseline at 24 weeks in each arm
Percentage of seizure reduction from baseline at 24 weeks in each arm will be calculated from Daily Seizure Log maintained by parents Percentage of seizure reduction at 24 weeks=x-y/x X 100 Y=Mean daily seizures at 24 weeks as measured over past 4 weeks X=Mean daily seizures at baseline as measured over 4 weeks Seizure log will contain details of number, duration and type of seizures as recorded by parents
Time frame: 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
Proportion of patients with >50% seizure reduction in each dietary arm
Proportion of patients with \>50% seizure reduction in each dietary arm will be computed from daily seizure log maintained by parents
Time frame: At the end of 24 weeks, it will be determined the proportion of children in each arm with >50% reduction in seizure frequency.
Change in social quotient with each dietary therapy
Proportion of children with improvement in social quotient at 24 weeks as compared to baseline measured by Vineland Social Maturity scale
Time frame: 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
Proportion of patients with different clinical adverse events in each group
Each participant will be monitored clinically for adverse effects like nausea, vomiting, constipation
Time frame: Each child will be monitored for adverse effects clinically at 12 weeks and 24 weeks
Correlate seizure frequency change at 24 weeks with blood HbA1c levels
Absolute level of blood HbA1c(in percentage) as compared to percentage change in seizure frequency at 3 and 6 months will be computed
Time frame: Absolute level of HbA1c levels (in percentage) as compared to percentage change in seizure frequency at 3 and 6 months will be computed
Correlate seizure frequency change at 24 weeks with blood betahydroxy butyrate levels levels
Blood beta hydroxyl butyrate levels(milimoles/liter) at 12 and 24 weeks as compared to percentage change in seizure frequency will be computed
Time frame: Blood beta hydroxyl butyrate levels(milimoles/liter) at 12 and 24 weeks as compared to percentage change in seizure frequency will be computed
Proportion of patients with different biochemical adverse events in each group
Each participant will be monitored for side effects like anemia, dyslipidemia, deranged liver and renal function tests
Time frame: 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
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