Use of the Atkins Diet for Adults With Intractable Epilepsy

Overview

This is a prospective study to determine whether the Atkins diet reduces seizures, creates ketosis, and is well tolerated in adults with epilepsy. Approximately 30 patients will be enrolled, expecting 20 to complete the 6-month study. The investigators plan to establish the seizure baseline and type, initiate the Atkins diet, then monitor its administration in terms of seizure reduction, ketosis, and side effects for a 6-month period.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Detailed Description

Patients are seen in the Johns Hopkins General Clinical Research Center (GCRC) and started on a modified Atkins diet (15g/day of carbohydrates). Medications remain unchanged and labs are drawn. Followup is at 1 month, 3 months, and 6 months into the study. After 1 month, carbohydrates and medications can be altered. Ketosis (urine) is measured by patients semiweekly, weight weekly, and seizures daily and recorded on a calendar. This study is ongoing with approximately 20 patients of 30 enrolled as of February 2006.

Interventions

  • Behavioral: Atkins diet (15 grams/day carbohydrates)

Clinical Trial Outcome Measures

Primary Measures

  • Seizure reduction

Secondary Measures

  • Ketosis
  • tolerability

Participating in This Clinical Trial

Inclusion Criteria

  • Ages 18 and over – Weekly seizures or 4 times per month – Use of at least 2 anticonvulsant drugs Exclusion Criteria:

  • Prior use of the Atkins diet for > 1 week – Prior use of the ketogenic diet within the past year – Kidney, heart disease, renal disease – Hypercholesterolemia – Pseudoseizures – Pregnancy – Body mass index (BMI) below 18.5 – Status epilepticus within the past 6 months – 2 week seizure-free period within the past 6 months

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Collaborator
    • National Center for Research Resources (NCRR)
  • Overall Official(s)
    • Eric H Kossoff, MD, Principal Investigator, Johns Hopkins University

References

Kossoff EH, Krauss GL, McGrogan JR, Freeman JM. Efficacy of the Atkins diet as therapy for intractable epilepsy. Neurology. 2003 Dec 23;61(12):1789-91. doi: 10.1212/01.wnl.0000098889.35155.72.

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