Efficacy and tolerability of classical and polyunsaturated fatty acids ketogenic diet in controlling paediatric refractory epilepsy - A randomized study.
Level 2 - randomized trial
Randomized controlled trial
PubMed 38908324 · doi:10.1016/j.eplepsyres.2024.107395
What was done
Children aged 2 to 10 years with refractory epilepsy (n = 52) were randomized to either a classical ketogenic diet (CKD, n = 25) or a polyunsaturated fatty acids ketogenic diet (PUFAKD, n = 27, using unsaturated fats with an omega-3 to omega-6 ratio of 1:2.8). Both diets maintained a fat to carbohydrate plus protein ratio between 2.2:1 and 4:1. Seizure frequency was evaluated at 3, 6, 9, and 12 months, categorized by percentage reduction (<50%, 50–90%, >90%, 100%). Adverse events (vomiting, nausea, lethargy, constipation) and urine ketone levels were monitored.
What was found
Both diets combined produced a significant reduction in seizures (p = 0.001), with an overall mean seizure reduction of 71.1% and no significant difference between groups (p = 0.488 for mean reduction; p = 0.537 for group comparison). Mean overall compliance was 78.3%, and higher compliance was significantly associated with greater seizure reduction (p = 0.042, Z = 4.039). However, children receiving PUFAKD experienced significantly higher rates of nausea (p = 0.033) and vomiting (p = 0.014) compared to those on CKD.
Why it matters
Replacing saturated fats with polyunsaturated fats in a ketogenic diet does not improve seizure control and introduces substantial gastrointestinal intolerance, supporting classical ketogenic formulations as the preferred clinical option.
Limits
Small sample size (52 children total), limiting statistical power to detect small efficacy differences. The abstract does not report specific group-level seizure reduction percentages across the categorical response tiers (<50% to 100%), nor does it report long-term retention or lipid profile outcomes. Ketone monitoring relied on semi-quantitative urine dipsticks rather than quantitative blood beta-hydroxybutyrate.
Cited by
- supports The classical ketogenic diet used for drug-resistant epilepsy consists of approximately 85% to 90% fat and 8% to 10% protein.