Use of the Atkins Diet for Adults With Intractable Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atkins diet (15 grams/day carbohydrates)
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring intractable, ketogenic, ketosis, Atkins
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
Sites / Locations
- Johns Hopkins Hospital GCRC
Outcomes
Primary Outcome Measures
Seizure reduction
Secondary Outcome Measures
Ketosis
tolerability
Full Information
NCT ID
NCT00121927
First Posted
July 15, 2005
Last Updated
January 26, 2010
Sponsor
Johns Hopkins University
Collaborators
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00121927
Brief Title
Use of the Atkins Diet for Adults With Intractable Epilepsy
Official Title
Use of the Atkins Diet for Adults With Intractable Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins University
Collaborators
National Center for Research Resources (NCRR)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
intractable, ketogenic, ketosis, Atkins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Atkins diet (15 grams/day carbohydrates)
Primary Outcome Measure Information:
Title
Seizure reduction
Secondary Outcome Measure Information:
Title
Ketosis
Title
tolerability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric H Kossoff, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital GCRC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
14694049
Citation
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.
Results Reference
background
Links:
URL
http://www.hopkinsmedicine.org/neurology_neurosurgery/specialty_areas/epilepsy/
Description
Center website
URL
http://www.atkinsforseizures.com
Description
Patient support network (non-medical) website
Learn more about this trial
Use of the Atkins Diet for Adults With Intractable Epilepsy
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