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 |
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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. |
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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 |