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. 2018 Nov 7;2018(11):CD001903. doi: 10.1002/14651858.CD001903.pub4

Seo 2007.

Methods Single‐centre randomised controlled trial, to compare 3:1 and 4:1 KD. Baseline period lasted 2 months. After a 3‐month period of the diet, participants who were seizure free in the 4:1 group were recommended to change to a 3:1 ratio, and participants who were not seizure free in the 3:1 group were recommended to change to a 4:1 ratio and were re‐evaluated after a further 3 months.
Participants 76 children (aged 4 months to 16 years), with > 4 seizures/month and seizures were not controlled by at least 3 AEDs. Study completed in Korea. All seizure types included
Interventions Participants were randomised into 2 groups, 4:1 KD group (40 participants) and 3:1 KD group (36 participants) and the diet was followed for 3 months
Outcomes
  • Seizure reduction rate

  • Tolerability

Notes 6 participants dropped out in both of the original groups. 2 participants in the 3:1 group dropped out due to diet intolerance and 1 participant in the 4:1 KD group. 1 participant in the 3:1 group dropped out due to acute pancreatitis. Other reasons for dropout of participants were not stated.
Exclusion criteria: children with metabolic disorders, known or suspected neurological degenerative disorders, or both
4:1 refers to 4 g fat to 1 g of carbohydrate and protein combined. 3:1 refers to 3 g fat to 1 g carbohydrate and protein combined
This study was financially supported by Yonsei University Research Fund of 2003.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Although study stated that participants were randomly assigned to each group, there was no information regarding how randomisation was achieved
Allocation concealment (selection bias) Unclear risk Insufficient information
Blinding (performance bias and detection bias) 
 All outcomes High risk Study did not report whether blinding was undertaken although it seems from the design of the study that blinding would not be possible
Incomplete outcome data (attrition bias) Low risk Number of dropouts and reasons for dropouts were reported and an ITT analysis was completed
Selective reporting (reporting bias) Unclear risk Protocol unavailable
Other bias Low risk No other sources of bias identified