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Clinical Trials/NCT00121927
NCT00121927
Completed
Not Applicable

Use of the Atkins Diet for Adults With Intractable Epilepsy

Johns Hopkins University1 site in 1 country30 target enrollmentJune 2004
ConditionsEpilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
Johns Hopkins University
Enrollment
30
Locations
1
Primary Endpoint
Seizure reduction
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
June 2007
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Seizure reduction

Secondary Outcomes

  • Ketosis
  • tolerability

Study Sites (1)

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