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Use of the Atkins Diet for Adults With Intractable Epilepsy

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ClinicalTrials.gov Identifier: NCT00121927
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : January 27, 2010
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: Atkins diet (15 grams/day carbohydrates) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of the Atkins Diet for Adults With Intractable Epilepsy
Study Start Date : June 2004
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy




Primary Outcome Measures :
  1. Seizure reduction

Secondary Outcome Measures :
  1. Ketosis
  2. tolerability


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00121927     History of Changes
Other Study ID Numbers: 04-02-27-08
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: January 27, 2010
Last Verified: February 2007

Keywords provided by Johns Hopkins University:
intractable
ketogenic
ketosis
Atkins

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