NCT03764956.

Study name	Comparison of efficacy of LGIT and MAD among children with drug resistant epilepsy
Methods	An open‐label randomised, non‐inferiority trial with parallel‐group design
Participants	Intend to enrol 110 children, aged 1 to 15 years with drug‐resistant epilepsy, willing to come for regular follow‐up, seizure frequency > 4 seizures per month, receiving optimal doses of ≥ 2 AEDs. For West syndrome, participants required to have ≥ 4 spasm cluster per month despite treatment with AEDs and adrenocorticotrophic hormone or vigabatrin; Participants excluded if they had a surgically remediable cause for their epilepsy, an inborn error of metabolism, previously received KD, MAD or LGIT diet, had chronic kidney disease, chronic liver disease/gastrointestinal illness, chronic heart disease (congenital and acquired), or a chronic respiratory illness.
Interventions	Intervention group received LGIT (food items with glycaemic index < 50 only) for 24 weeks; Intervention group received MAD (20 g carbohydrate per day, increased fat and protein ratio) for 24 weeks.
Outcomes	Primary outcome: Percentage seizure reduction from baseline to 24 weeks; Secondary outcomes: Greater than 50% seizure reduction at 24 weeks; Rate of adverse effects at 24 weeks; Compliance assessed each week (satisfactory or unsatisfactory); Change in social quotient at 24 weeks measured by Vineland Social Maturity scale; Change in quality of life of participants < 4 years measured by Pediatric Quality of Life inventory at 24 weeks; Change in quality of life of participants ≥ 4 years measured by Quality of Life in Childhood Epilepsy questionnaire at 24 weeks; Change in quality of life of caregivers measured by the World Health Organization Quality of Life questionnaire at 24 weeks; Gut microbiota analysis pre‐ and post‐dietary therapy at 24 weeks; Change in behavioural abnormalities at 24 weeks.
Starting date	26/12/2018
Contact information	sheffaligulati@gmail.com drvyshakhanandmp@gmail.com
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