NCT03464487.

Study name	Comparison between efficacy of daily and intermittent low glycaemic index therapy diet among children with drug resistant epilepsy aged 1‐15 years: an open labeled randomized controlled parallel design non‐inferiority trial
Methods	An open‐label, randomised, controlled, parallel‐group design, non‐inferiority trial.
Participants	Aim to enrol 110 children, aged 1 to 15 years, with drug‐resistant epilepsy who were willing to attend regular follow‐up; Exclusion criteria: if there was a surgically remediable cause for their epilepsy, a proven inborn error of metabolism except in which dietary therapy for epilepsy is indicated (i.e. pyruvate carboxylase deficiency and glucose transporter type 1 (GLUT 1) deficiency), 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 daily LGIT, alongside AEDs (40 g to 60 g carbohydrate per day, carbohydrates required to have glycemic index less than 50) for 6 months; Intervention group received daily LGIT for five days of each week, alongside AEDs, plus two days of liberal diet (40 g to 60 g carbohydrate per day for five days per week, carbohydrates required to have glycemic index less than 50) for 6 months.
Outcomes	Primary outcome: Percentage of seizure reduction from baseline at 24 weeks; Secondary outcomes: Greater than 50% seizure reduction at 6 months; Improvement in social quotient at 6 months, measured by Vineland Social Maturity scale; Rate of adverse effects at 3 months and 6 months; Correlation between seizure frequency and change with blood haemoglobin A1c levels at 3 months and 6 months; Correlation between seizure frequency and change with blood betahydroxybutyrate levels at 3 months and 6 months; Rate of biochemical adverse effects at 6 months.
Starting date	15/02/2018
Contact information	sheffaligulati@gmail.com
Notes	Estimated study completion date was January 2019 however, at the time of publishing, the ClinicalTrials.gov entry reported that the study was still recruiting participants.