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Efficacy of Ketogenic Diets for Infant Epilepsy


Clinical trial examines the effect of a keto diet on infants with epilepsy

Epilepsy in infants poses significant challenges, often leading to difficulties in controlling seizures and impacting their neurological development. A phase 4 clinical trial investigated the potential of using a classic ketogenic diet as an alternative treatment method for infants with drug-resistant epilepsy. This article aims to present the findings of this trial, shedding light on its significance in managing epilepsy in infants.


Clinical Trial

Conducted in multiple hospitals across the UK, the trial enrolled infants aged 1–24 months who experienced drug-resistant epilepsy, characterized by frequent seizures despite trying two or more antiseizure medications. The study involved two groups: one received a classic ketogenic diet, and the other was given additional antiseizure medication, both for 8 weeks.



The primary aim of the trial was to measure the average number of seizures per day during weeks 6–8. Surprisingly, the trial results indicated that the ketogenic diet didn’t significantly reduce seizure frequency compared to providing additional antiseizure medication. Both groups showed similar median seizure rates during these weeks, with the ketogenic diet group experiencing an average of 5 seizures per day and the medication group facing around 3 seizures per day.


Safety and Tolerability

While the efficacy between the two treatments didn’t show a noticeable difference, the trial confirmed the safety of ketogenic diets for infants with drug-resistant epilepsy. Serious adverse events occurred at similar rates in both groups, with seizures being the most common event. However, the trial reported three unfortunate deaths, all occurring in infants assigned to the ketogenic diet group. Nevertheless, thorough investigations by local principal investigators and the data safety monitoring committee concluded that these deaths were unrelated to the treatment.



Though the trial didn’t demonstrate a significant difference in reducing seizure frequency between the ketogenic diet and additional medication, it did shed light on the safety and potential of ketogenic diets as an alternative treatment option. This finding may pave the way for considering dietary interventions in cases where conventional treatments prove ineffective.

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While the trial didn’t show a substantial difference in reducing seizure frequency between the ketogenic diet and further antiseizure medication in infants with drug-resistant epilepsy, it emphasized the safety and potential of ketogenic diets as an alternative treatment. These diets might be considered for infants experiencing persistent seizures despite multiple antiseizure medications, offering a new avenue for managing this challenging condition.


It is crucial to consult healthcare professionals for personalized treatment plans. Furthermore, further research is necessary to gain a deeper understanding of the role of dietary interventions in managing epilepsy in infants.


The Lancet, Dec-2023

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This content is for informational and educational purposes only. It is not intended to provide medical advice or to take the place of such advice or treatment from a personal physician. All readers/viewers of this content are advised to consult their doctors or qualified health professionals regarding specific health questions. CenTrial Data Ltd. does not take responsibility for possible health consequences of any person or persons reading or following the information in this educational content. Treatments and clinical trials mentioned may not be appropriate or available for all trial participants. Outcomes from treatments and clinical trials may vary from person to person. Consult with your doctor as to whether a clinical trial is a suitable option for your condition. Assistance from generative AI tools may have been used in writing this article.