Dietary Therapy In Epilepsy Treatment (DIET-Trial): A Randomised Non Inferiority Trial Comparing KD, MAD & LGIT for Drug Resistant Epilepsy (DIET)
Drug Resistant Epilepsy
About this trial
This is an interventional treatment trial for Drug Resistant Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Children aged 1-15 years with drug resistant epilepsy (Drug resistant epilepsy for the study will be defined as seizure frequency >4 seizures per month, and treatment failure of ≥2 prescribed antiepileptic drugs).
- Willing to come for regular follow up
Exclusion Criteria:
- Surgically remediable cause for drug resistant epilepsy
- Proven inborn error of metabolism except those in which KD is indicated (i.e., Pyruvate Carboxylase deficiency and GLUT-1 Deficiency)
- Previously received KD, MAD or LGIT
Known case of
- Chronic kidney disease
- Chronic liver disease/ GI illness
- Chronic heart disease (congenital and acquired)
- Chronic respiratory illness
Sites / Locations
- All India Institute of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Ketogenic Diet
Modified Atkins Diet
Low Glycemic Index Therapy
Ketogenic diet (KD) will be administered by the non-fasting protocol. The child will be admitted to the hospital, and KD will be started in 1:1 ratio. The ratio will increased every 48hours to a maximum of 4:1 or ketosis (urinary ketones 40-80mg/dL) is attained. The child will thereafter be discharged and followed up on Out patient basis.
Modified Atkins Diet (MAD) will be administered on out patient basis. Parents of children will be advised to monitor for seizure frequency and ketosis at home.
Low Glycemic Index Therapy (LGIT) will be administered on out patient basis. Parents of children will be advised to monitor for seizure frequency and ketosis at home.