Tanya J W McDonald1, Bobbie J Henry-Barron2, Elizabeth A Felton3, Erie G Gutierrez4, Joanne Barnett5, Rebecca Fisher6, MonYi Lwin7, Amanda Jan8, Diane Vizthum9, Eric H Kossoff10, Mackenzie C Cervenka11. 1. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States. Electronic address: twill145@jhmi.edu. 2. Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, United States. Electronic address: bjhenry@jhu.edu. 3. Department of Neurology, University of Wisconsin, Madison, WI, United States. Electronic address: felton@neurology.wisc.edu. 4. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States. Electronic address: egonz24@jhmi.edu. 5. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States. Electronic address: jbarne14@jhmi.edu. 6. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States. Electronic address: rfisher2@jhmi.edu. 7. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States. Electronic address: mlwin3@jhu.edu. 8. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States. Electronic address: amanda@thejans.net. 9. Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, United States. Electronic address: dblahut1@jhmi.edu. 10. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States; Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, United States. Electronic address: ekossoff@jhmi.edu. 11. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States. Electronic address: mcerven1@jhmi.edu.
Abstract
PURPOSE: To determine whether use of a ketogenic formula during the first month of the modified Atkins diet (MAD) in adults with drug-resistant epilepsy (DRE) improves seizure reduction and compliance compared to MAD alone. METHODS:Eighty adults (age ≥18 years) with DRE and ≥4 reliably quantifiable seizures/month were enrolled. All participants were trained to follow a 20 g/day net carbohydrate limit MAD. Patients were randomized to receive one 8-ounce (237 mL) tetrapak of KetoCal®, a 4:1 ketogenic ratio formula, daily in combination with MAD during the first month (treatment arm) or second month (control/cross-over arm). Patients recorded urine ketones, weight, and seizure frequency and followed up at 1 and 2 months. RESULTS: By 1 month, 84% of patients achieved ketosis (median of 4-4.5 days). At 1 month, the treatment arm had a significantly higher ketogenic ratio and more patients with a ≥1:1 ketogenic ratio compared to the control arm. There was no difference in median seizure frequency, proportion of responders (≥50% seizure reduction), or median seizure reduction from baseline between groups. However, patients treated with KetoCal® during the first month were significantly more likely to continue MAD for 6 months or more. CONCLUSION: Although supplementing MAD with a ketogenic formula in the first month did not increase the likelihood of reducing seizures compared to MAD alone, significantly more adults remained on MAD long-term with this approach. This suggests a potential strategy for encouraging compliance with MAD in adults with DRE.
RCT Entities:
PURPOSE: To determine whether use of a ketogenic formula during the first month of the modified Atkins diet (MAD) in adults with drug-resistant epilepsy (DRE) improves seizure reduction and compliance compared to MAD alone. METHODS: Eighty adults (age ≥18 years) with DRE and ≥4 reliably quantifiable seizures/month were enrolled. All participants were trained to follow a 20 g/day net carbohydrate limit MAD. Patients were randomized to receive one 8-ounce (237 mL) tetrapak of KetoCal®, a 4:1 ketogenic ratio formula, daily in combination with MAD during the first month (treatment arm) or second month (control/cross-over arm). Patients recorded urine ketones, weight, and seizure frequency and followed up at 1 and 2 months. RESULTS: By 1 month, 84% of patients achieved ketosis (median of 4-4.5 days). At 1 month, the treatment arm had a significantly higher ketogenic ratio and more patients with a ≥1:1 ketogenic ratio compared to the control arm. There was no difference in median seizure frequency, proportion of responders (≥50% seizure reduction), or median seizure reduction from baseline between groups. However, patients treated with KetoCal® during the first month were significantly more likely to continue MAD for 6 months or more. CONCLUSION: Although supplementing MAD with a ketogenic formula in the first month did not increase the likelihood of reducing seizures compared to MAD alone, significantly more adults remained on MAD long-term with this approach. This suggests a potential strategy for encouraging compliance with MAD in adults with DRE.
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