Raju 2011.

Methods	Randomised, non‐blinded, open‐label, parallel controlled trial, to compare a 4:1 and a 2.5:1 ratio KD over a 3‐month period
Participants	38 children aged 6 months to 5 years, with drug‐resistant epilepsy, at least 2 seizures/month, despite appropriate use of at least 2 AEDs and at least 1 newer AED Study undertaken in India
Interventions	Participants were randomised into 1 of 2 groups; a 4:1 ratio KD (19 participants) and 2.5:1 KD (19 participants) and followed for 3 months
Outcomes	> 50% reduction in seizure frequency Adverse effects
Notes	3 participants in each group dropped out of the study. Reasons for dropout in 4:1 KD group were refusal to eat, unsatisfactory seizure control and non‐acceptance by other family members. In 2.5:1 KD group, 2 participants dropped out due to unsatisfactory seizure control and 1 due to refusal to eat. Exclusion criteria: known or suspected inborn errors of metabolism, systemic illness or surgical remediable causes of epilepsy. 4:1 refers to 4 g fat to 1 g of carbohydrate and protein combined. 2.5:1 refers to 2.5 g fat to 1 g of carbohydrate and protein combined. No funding was received for this study.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Sequence generation 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	Study was unblinded
Incomplete outcome data (attrition bias)	Low risk	Attrition was reported and was fairly equal across the groups. ITT analysis carried out
Selective reporting (reporting bias)	Unclear risk	Protocol unavailable
Other bias	High risk	Participants were all < 18 years of age and there was a high rate of comorbidity