| Study characteristics |
| 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; Exclusion criteria: known or suspected inborn errors of metabolism, systemic illness or surgical remediable causes of epilepsy; Epilepsy syndromes included were West syndrome (9 participants in 4:1 KD group and 7 participants in 2.5:1 KD group), Lennox‐Gastaut syndrome (8 participants in 4:1 KD group and 9 participants in 2.5:1 KD group), Doose (no participants in 4:1 KD group and 2 participants in 2.5:1 KD group) and unclassified syndromes (2 participants in 4:1 KD group and 1 participant in 2.5:1 KD group). The trial included participants with cerebral palsy (15 participants in 4:1 KD group and 9 participants in 2.5:1 KD group). |
| 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; 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. |
| Outcomes |
|
| Notes |
3 participants in each group dropped out of the study. Reasons for drop out 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; 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 of participants and personnel (performance bias)
All outcomes |
High risk |
Open‐label study meaning participants and personnel were not blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Open‐label study meaning outcome assessors were not blinded. |
| 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. |
