Use of the Atkins Diet for Adults With Intractable Epilepsy

January 26, 2010 updated by: Johns Hopkins University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital GCRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Seizure reduction

Secondary Outcome Measures

Outcome Measure
Ketosis
tolerability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Center for Research Resources (NCRR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion

June 1, 2007

Study Registration Dates

First Submitted

July 15, 2005

First Submitted That Met QC Criteria

July 15, 2005

First Posted (Estimate)

July 21, 2005

Study Record Updates

Last Update Posted (Estimate)

January 27, 2010

Last Update Submitted That Met QC Criteria

January 26, 2010

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-02-27-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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