CTRI/2015/07/006048.

Study name	Modified Atkins diet in adolescence and adults with drug‐resistant epilepsy
Methods	An unblinded, randomised controlled trial.
Participants	Aimed to recruit 160 people, aged 10 to 55 years, with drug‐resistant epilepsy. Included participants experiencing persistent, daily countable seizures (more than 2 per month for 6 months), willing to attend regular follow‐up and maintain seizure frequency accurately and willing to perform induction phase of diet. Potencial participants excluded if less than 10 years of age, surgically remediable causes of epilepsy, clinical features of inborn metabolism, suspicion of a metabolic disorder, refusal to give consent, tried KD in past year, BMI < 18 and > 30 kg/m2, two or more of the following: high blood ammonia (> 80 mmol/L), high arterial lactate (> 2 mmol/L), metabolic acidosis (pH > 7.2), hypoglycaemia (< 40 mg/dL)
Interventions	Intervention group treated with MAD (20 g carbohydrate per day) for 6 months; Control arm receive normal diet with no dietetic input for 6 months, following which MAD can be offered.
Outcomes	Primary outcome: Greater than 50% seizure reduction at 6 months; Secondary outcomes: Rate and characteristics of short‐term adverse effects while on MAD; Rate of withdrawal from the MAD diet during the study period and reasons for withdrawal; Change in quality of life of both groups during the study period.
Starting date	18 August 2015
Contact information	manjari2tripathi@gmail.com
Notes	Recruitment expected to be complete June 2018.