Sharma 2013.

Methods	Open‐label, single‐centre, parallel‐group, randomised controlled trial, to compare the MAD to a control group over a 3‐month period. Authors noted the study design to be similar to that of Neal 2008. There was a 4‐week baseline of seizure frequency.
Participants	102 children aged 2‐14 years with drug‐resistant epilepsy and 2‐14 daily seizures, having previously tried 3 AEDs. Study conducted in India
Interventions	Randomised into 1 of 2 groups; MAD (50 participants) or a normal diet (52 participants) for a period of 3 months
Outcomes	Seizure frequency Tolerability Adverse effects
Notes	4 children reported to have dropped out of the trial. 2 secondary to lower respiratory tract infections, 1 secondary to hyperammonaemic encephalopathy and 1 as the child and family found the diet too restrictive. In the control group, 3 participants were lost to follow‐up. Exclusion criteria: known or suspected inborn errors of metabolism, systemic illness or motivational issues the family that would prelude compliance. The lead author (Sharma) was financially supported as a Senior Research Associate in the “Scientists pool scheme” of the Council for Scientific and Industrial Research (CSIR), Government. of India, for this study.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation sequence was computer generated
Allocation concealment (selection bias)	Low risk	Opaque sealed envelopes were used to conceal allocation.
Blinding (performance bias and detection bias) All outcomes	High risk	Unblinded
Incomplete outcome data (attrition bias)	Low risk	Study attrition reported an ITT analysis carried out
Selective reporting (reporting bias)	Low risk	Protocol available 15 August 2015 (clinicaltrials.gov/ct2/show/NCT00836836; Sharma 2009)
Other bias	High risk	Excluded participants where motivational issues within the family were noted