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The efficacy of the ketogenic diet in infants and young children with refractory epilepsies using a formula-based powder

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Abstract

To evaluate the efficacy, safety, and tolerability of a classic 4:1 ketogenic diet using a formula-based powder in infants and children with refractory seizures who are reluctant to eat homemade foods. We conducted an open label trial and administered a ketogenic diet using formula-based power (Ketocal®). Twenty-seven infants and children aged between 12 months and 5 years were enrolled who had refractory seizures and were reluctant to eat homemade foods. Of 27 children, 5 were lost to follow-up and 22 were remained at the end of the study. After 4 months, the median frequency of seizures per week was reduced >50% in 68.2% of patients, while 9/22 children (40.9%) showed a 50–90% reduction in seizure frequency per week, and 6/22 children (27.3%) showed more than 90% reduction in seizure frequency per week. Over the study course, 6/22 (27%) children who continued to receive the diet developed constipation, one child developed gastroesophageal reflux, and one child developed hypercholesterolemia. None of these children discontinued the diet because of the complications. Thirteen children and their parents (59%) reported that the diet was palatable and tolerable enough. The ketogenic diet using a formula-based powder (Ketocal®) is effective, safe, and tolerable in infants and children with refractory seizures who are reluctant to eat homemade foods according to the rules of the ketogenic diet.

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Acknowledgements

This paper is from the thesis of Seyed Ahmad Hosseini, M.D., registration number (IRCT20121001690N5). Nutricia company and the Research Deputy of Tehran University of Medical Sciences provided financial and logistic support for this study (IRCT20121001690N5) but had no role in study design; data collection, analysis, or interpretation; writing the report; or in the decision to submit the article for publication. The authors are grateful to all parents and patients for their participation in this study. We are extremely indebted to the authorities of Research Deputy of Tehran University of Medical Sciences and Nutricia Company especially Mr Abdullah Cem Atay and Mrs Mojdeh Zohari for their financial support and providing the Ketocal® formulas and the staff of the nutrition ward of the Children’s Medical Center for their kind cooperation.

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Correspondence to Reza Azizi Malamiri.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all parents of children included in the study.

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Ashrafi, M.R., Hosseini, S.A., Zamani, G.R. et al. The efficacy of the ketogenic diet in infants and young children with refractory epilepsies using a formula-based powder. Acta Neurol Belg 117, 175–182 (2017). https://doi.org/10.1007/s13760-016-0732-0

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