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Use of the Atkins Diet for Adults With Intractable Epilepsy

This study has been completed.
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00121927
First received: July 15, 2005
Last updated: January 26, 2010
Last verified: February 2007
History of Changes
  Purpose

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.


Condition Intervention
Epilepsy
 Behavioral: Atkins diet (15 grams/day carbohydrates)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of the Atkins Diet for Adults With Intractable Epilepsy

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Seizure reduction

Secondary Outcome Measures:
  • Ketosis
  • tolerability

Estimated Enrollment: 30
Study Start Date: June 2004
Estimated Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121927

Locations
United States, Maryland
Johns Hopkins Hospital GCRC
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Eric H Kossoff, MD Johns Hopkins Medical Institutions
  More Information

Additional Information:
Center website  This link exits the ClinicalTrials.gov site
Patient support network (non-medical) website  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00121927     History of Changes
Other Study ID Numbers: 04-02-27-08
Study First Received: July 15, 2005
Last Updated: January 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
intractable
ketogenic
ketosis
Atkins

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013